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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02568267
Registration number
NCT02568267
Ethics application status
Date submitted
2/10/2015
Date registered
5/10/2015
Date last updated
21/06/2024
Titles & IDs
Public title
Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions)
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Scientific title
An Open-Label, Multicenter, Global Phase 2 Basket Study of Entrectinib for the Treatment of Patients With Locally Advanced or Metastatic Solid Tumors That Harbor NTRK1/2/3, ROS1, or ALK Gene Rearrangements
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Secondary ID [1]
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2015-003385-84
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Secondary ID [2]
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RXDX-101-02
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Universal Trial Number (UTN)
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Trial acronym
STARTRK-2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
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Cholangiocarcinoma
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Colorectal Cancer
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Head and Neck Neoplasms
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Lymphoma, Large-Cell, Anaplastic
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Melanoma
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Neuroendocrine Tumors
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Non-Small Cell Lung Cancer
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Ovarian Cancer
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Pancreatic Cancer
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Papillary Thyroid Cancer
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Primary Brain Tumors
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Renal Cell Carcinoma
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Sarcomas
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Salivary Gland Cancers
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Adult Solid Tumor
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Condition category
Condition code
Cancer
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Lung - Non small cell
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Cancer
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Bowel - Back passage (rectum) or large bowel (colon)
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Cancer
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0
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0
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Malignant melanoma
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Cancer
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Pancreatic
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Cancer
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Ovarian and primary peritoneal
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Cancer
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Sarcoma (also see 'Bone') - soft tissue
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Cancer
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0
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Bone
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Cancer
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Brain
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Cancer
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Thyroid
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Cancer
0
0
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Biliary tree (gall bladder and bile duct)
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Oral and Gastrointestinal
0
0
0
0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Cancer
0
0
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0
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Neuroendocrine tumour (NET)
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Cancer
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Head and neck
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Cancer
0
0
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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0
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0
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Drugs - Entrectinib
Experimental: NTRK1/2/3-rearranged NSCLC - Oral entrectinib (RXDX-101)
Experimental: ROS1-rearranged NSCLC - Oral entrectinib (RXDX-101)
Experimental: ALK- or ROS1-rearranged NSCLC - with CNS-only progression previously treated with crizotinib (NOTE: The ALK-rearranged portion of this arm is now closed to enrollment.)
Oral entrectinib (RXDX-101)
Experimental: NTRK/1/2/3-rearranged mCRC - Oral entrectinib (RXDX-101)
Experimental: ROS1-rearranged mCRC - Oral entrectinib (RXDX-101)
Experimental: ALK-rearranged mCRC - Oral entrectinib (RXDX-101)
Experimental: NTRK1/2/3-rearranged other solid tumor - Oral entrectinib (RXDX-101)
Experimental: ROS1-rearranged other solid tumor - Oral entrectinib (RXDX-101)
Experimental: ALK-rearranged other solid tumor - Oral entrectinib (RXDX-101)
Treatment: Drugs: Entrectinib
TrkA/B/C, ROS1, and ALK inhibitor
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Objective Response Rate
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Assessment method [1]
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Assessed by blinded independent central review (BICR) using RECIST v1.1
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Timepoint [1]
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Approximately 24 months
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Secondary outcome [1]
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Duration of Response
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Assessment method [1]
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Assessed by blinded independent central review (BICR) using RECIST v1.1
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Timepoint [1]
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Approximately 24 months
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Secondary outcome [2]
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Time to Response
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Assessment method [2]
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Assessed by blinded independent central review (BICR) using RECIST v1.1
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Timepoint [2]
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Approximately 24 months
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Secondary outcome [3]
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Clinical Benefit Rate
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Assessment method [3]
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Assessed by blinded independent central review (BICR) using RECIST v1.1
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Timepoint [3]
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Approximately 24 months
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Secondary outcome [4]
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Intracranial Tumor Response
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Assessment method [4]
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Assessed by blinded independent central review (BICR) using RANO or RANO-BM, as applicable
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Timepoint [4]
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Approximately 24 months
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Secondary outcome [5]
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CNS Progression-free Survival
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Assessment method [5]
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Assessed by blinded independent central review (BICR) using RANO or RANO-BM, as applicable
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Timepoint [5]
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Approximately 24 months
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Secondary outcome [6]
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Progression-free Survival
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Assessment method [6]
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Assessed by Kaplan-Meier method
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Timepoint [6]
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Approximately 30 months
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Secondary outcome [7]
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Overall Survival
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Assessment method [7]
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Assessed by Kaplan-Meier method
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Timepoint [7]
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Approximately 36 months
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Secondary outcome [8]
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Population PK
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Assessment method [8]
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Assessed by Kaplan-Meier method
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Timepoint [8]
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Approximately 24 months
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Secondary outcome [9]
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Adverse Events
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Assessment method [9]
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Type, incidence, severity, timing, seriousness, and relatedness of adverse events and laboratory abnormalities, graded by the NCI CTCAE
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Timepoint [9]
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Approximately 36 months
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Secondary outcome [10]
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Quality of Life
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Assessment method [10]
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Assessed with the European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) and the Euro-QoL Group EQ-5D. NSCLC and mCRC patients will complete the lung cancer and colorectal cancer specific modules, QLQ-LC13 and QLQ-CR29, respectively
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Timepoint [10]
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Approximately 24 months
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Secondary outcome [11]
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Bone Growth and Bone Mineral Density
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Assessment method [11]
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Assessed with DHA scans
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Timepoint [11]
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Approximately 30 months
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Secondary outcome [12]
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Bone Biomarkers
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Assessment method [12]
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Measured by blood
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Timepoint [12]
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Approximately 30 months
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Eligibility
Key inclusion criteria
* Histologically- or cytologically-confirmed diagnosis of locally advanced or metastatic solid tumor that harbors an NTRK1/2/3, ROS1, or ALK gene rearrangement
* For patients enrolled via local molecular testing, an archival or fresh tumor tissue (unless medically contraindicated) is required to be submitted for independent central molecular testing at Ignyta's CLIA laboratory post-enrollment
* Measurable or evaluable disease
* Patients with CNS involvement, including leptomeningeal carcinomatosis, which is either asymptomatic or previously-treated and controlled, are allowed
* Prior anticancer therapy is allowed (excluding approved or investigational Trk, ROS1, or ALK inhibitors in patients who have tumors that harbor those respective gene rearrangements)
- Note: prior treatment with crizotinib is permitted only in ALK- or ROS1-rearranged NSCLC patients presenting with CNS-only progression. Other ALK inhibitors are prohibited.
* At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed after prior chemotherapy or small molecule targeted therapy
* At least 4 weeks must have elapsed since completion of antibody-directed therapy
* Prior radiotherapy is allowed if more than 14 days have elapsed since the end of treatment
* Eastern Cooperative Oncology Group (ECOG) performance status = 2 and minimum life expectancy of 4 weeks
* Adequate organ function as defined per protocol
* Ability to swallow entrectinib intact
* Other protocol specified criteria
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Current participation in another therapeutic clinical trial
* Prior treatment with approved or investigational Trk, ROS1, or ALK inhibitors in patients who have tumors that harbor those respective gene rearrangements
- Note: prior treatment with crizotinib is permitted only in ALK- or ROS1-rearranged NSCLC patients presenting with CNS-only progression. Other ALK inhibitors are prohibited.
* History of other previous cancer that would interfere with the determination of safety or efficacy
* Familial or personal history of congenital bone disorders, or bone metabolism alterations
* Incomplete recovery from any surgery
* History of recent (within the past 3 months) symptomatic congestive heart failure or ejection fraction =50% observed during screening for the study
* History of non-pharmacologically induced prolonged QTc interval
* History of additional risk factors for torsades de pointes
* Peripheral neuropathy Grade = 2
* Known active infections
* Active gastrointestinal disease or other malabsorption syndromes
* Known interstitial lung disease, interstitial fibrosis, or history of tyrosine kinase inhibitor-induced pneumonitis
* Other protocol specified criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
19/11/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/04/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
534
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Recruitment hospital [1]
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Liverpool Hospital - Liverpool
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Recruitment hospital [2]
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Newcastle Private Hospital - New Lambton Heights
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Recruitment hospital [3]
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Flinders Medical Centre - Bedford Park
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Recruitment hospital [4]
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Austin Health - Heidelberg
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Recruitment postcode(s) [1]
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2170 - Liverpool
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Recruitment postcode(s) [2]
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2305 - New Lambton Heights
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Recruitment postcode(s) [3]
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5042 - Bedford Park
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Recruitment postcode(s) [4]
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3084 - Heidelberg
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Recruitment outside Australia
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United States of America
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Arizona
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Connecticut
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United States of America
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District of Columbia
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United States of America
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Florida
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Country [7]
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United States of America
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State/province [7]
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Georgia
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Country [8]
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United States of America
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State/province [8]
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Illinois
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Country [9]
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United States of America
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State/province [9]
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Maryland
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Country [10]
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United States of America
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State/province [10]
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Massachusetts
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Country [11]
0
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United States of America
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State/province [11]
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Michigan
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Country [12]
0
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United States of America
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State/province [12]
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Minnesota
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United States of America
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Missouri
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United States of America
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Nevada
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Oklahoma
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Country [19]
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United States of America
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Oregon
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United States of America
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Pennsylvania
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United States of America
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Texas
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United States of America
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Utah
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United States of America
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Virginia
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United States of America
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Washington
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Belgium
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State/province [25]
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Edegem
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Country [26]
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China
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Beijing
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Country [27]
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China
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Chengdu
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Country [28]
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China
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Guangzhou
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China
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Harbin
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Country [30]
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China
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Shanghai City
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China
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Shanghai
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China
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Shenzhen
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China
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State/province [33]
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Tianjin
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Country [34]
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China
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Wuhan City
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Country [35]
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China
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State/province [35]
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Zhejiang
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Country [36]
0
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France
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State/province [36]
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Angers
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Country [37]
0
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France
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Bordeaux
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France
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Lyon
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Country [39]
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France
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Marseille cedex 5
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France
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Marseille
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France
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Montpellier cedex 5
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France
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Paris
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France
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Saint Herblain
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France
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Toulouse
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France
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Villejuif cedex
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Germany
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Berlin
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Germany
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Dresden
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Germany
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Göttingen
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Germany
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Heidelberg
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Germany
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Köln
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Hong Kong
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Hong Kong
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Kowloon
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Hong Kong
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Shatin
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Italy
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Campania
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Italy
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Lazio
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Italy
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Lombardia
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Italy
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Toscana
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Italy
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Umbria
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Italy
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Veneto
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Japan
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Aichi
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Japan
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Ehime
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Japan
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Fukuoka
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Japan
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Hyogo
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Japan
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Kashiwa-shi
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Japan
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Miyagi
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Japan
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Niigata
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Japan
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Osaka
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Japan
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Shizuoka
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Korea, Republic of
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Seoul
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Netherlands
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Amsterdam
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Netherlands
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Leiden
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Poland
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Gdansk
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Poland
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Gliwice
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Poland
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Pozna?
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Poland
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Warszawa
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Singapore
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Singapore
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Spain
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Madrid
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Spain
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Barcelona
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Spain
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Malaga
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Spain
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Sevilla
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Taiwan
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Tainan
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Taiwan
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Taipei City
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Taiwan
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Taipei
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United Kingdom
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Cambridge
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United Kingdom
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London
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United Kingdom
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State/province [86]
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Manchester
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Hoffmann-La Roche
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is an open-label, multicenter, global Phase 2 basket study of entrectinib (RXDX-101) for the treatment of patients with solid tumors that harbor an NTRK1/2/3, ROS1, or ALK gene fusion. Patients will be assigned to different baskets according to tumor type and gene fusion.
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Trial website
https://clinicaltrials.gov/study/NCT02568267
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Trial related presentations / publications
Sullivan WG, Hatswell AJ. Letter re: 'Intrapatient comparisons of efficacy in a single-arm trial of entrectinib in tumour-agnostic indications'. ESMO Open. 2021 Dec;6(6):100282. doi: 10.1016/j.esmoop.2021.100282. Epub 2021 Oct 28. No abstract available. Doebele RC, Perez L, Trinh H, Martinec M, Martina R, Riehl T, Krebs MG, Meropol NJ, Wong WB, Crane G. Comparative effectiveness analysis between entrectinib clinical trial and crizotinib real-world data in ROS1+ NSCLC. J Comp Eff Res. 2021 Dec;10(17):1271-1282. doi: 10.2217/cer-2021-0131. Epub 2021 Aug 24. Erratum In: J Comp Eff Res. 2022 May;11(7):545-548. doi: 10.2217/cer-2021-0131c1. Dziadziuszko R, Krebs MG, De Braud F, Siena S, Drilon A, Doebele RC, Patel MR, Cho BC, Liu SV, Ahn MJ, Chiu CH, Farago AF, Lin CC, Karapetis CS, Li YC, Day BM, Chen D, Wilson TR, Barlesi F. Updated Integrated Analysis of the Efficacy and Safety of Entrectinib in Locally Advanced or Metastatic ROS1 Fusion-Positive Non-Small-Cell Lung Cancer. J Clin Oncol. 2021 Apr 10;39(11):1253-1263. doi: 10.1200/JCO.20.03025. Epub 2021 Mar 1. Drilon A, Siena S, Dziadziuszko R, Barlesi F, Krebs MG, Shaw AT, de Braud F, Rolfo C, Ahn MJ, Wolf J, Seto T, Cho BC, Patel MR, Chiu CH, John T, Goto K, Karapetis CS, Arkenau HT, Kim SW, Ohe Y, Li YC, Chae YK, Chung CH, Otterson GA, Murakami H, Lin CC, Tan DSW, Prenen H, Riehl T, Chow-Maneval E, Simmons B, Cui N, Johnson A, Eng S, Wilson TR, Doebele RC; trial investigators. Entrectinib in ROS1 fusion-positive non-small-cell lung cancer: integrated analysis of three phase 1-2 trials. Lancet Oncol. 2020 Feb;21(2):261-270. doi: 10.1016/S1470-2045(19)30690-4. Epub 2019 Dec 11. Erratum In: Lancet Oncol. 2020 Feb;21(2):e70. doi: 10.1016/S1470-2045(20)30007-3. Lancet Oncol. 2020 Jul;21(7):e341. doi: 10.1016/S1470-2045(20)30346-6. Doebele RC, Drilon A, Paz-Ares L, Siena S, Shaw AT, Farago AF, Blakely CM, Seto T, Cho BC, Tosi D, Besse B, Chawla SP, Bazhenova L, Krauss JC, Chae YK, Barve M, Garrido-Laguna I, Liu SV, Conkling P, John T, Fakih M, Sigal D, Loong HH, Buchschacher GL Jr, Garrido P, Nieva J, Steuer C, Overbeck TR, Bowles DW, Fox E, Riehl T, Chow-Maneval E, Simmons B, Cui N, Johnson A, Eng S, Wilson TR, Demetri GD; trial investigators. Entrectinib in patients with advanced or metastatic NTRK fusion-positive solid tumours: integrated analysis of three phase 1-2 trials. Lancet Oncol. 2020 Feb;21(2):271-282. doi: 10.1016/S1470-2045(19)30691-6. Epub 2019 Dec 11. Erratum In: Lancet Oncol. 2020 Feb;21(2):e70. doi: 10.1016/S1470-2045(20)30029-2. Lancet Oncol. 2020 Jul;21(7):e341. doi: 10.1016/S1470-2045(20)30345-4. Lancet Oncol. 2020 Aug;21(8):e372. doi: 10.1016/S1470-2045(20)30382-X. Lancet Oncol. 2021 Oct;22(10):e428. doi: 10.1016/S1470-2045(21)00538-6. Sigal D, Tartar M, Xavier M, Bao F, Foley P, Luo D, Christiansen J, Hornby Z, Maneval EC, Multani P. Activity of Entrectinib in a Patient With the First Reported NTRK Fusion in Neuroendocrine Cancer. J Natl Compr Canc Netw. 2017 Nov;15(11):1317-1322. doi: 10.6004/jnccn.2017.7029.
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