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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03964727
Registration number
NCT03964727
Ethics application status
Date submitted
29/04/2019
Date registered
28/05/2019
Titles & IDs
Public title
Study of Sacituzumab Govitecan in Participants With Metastatic Solid Tumors
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Scientific title
A Phase 2 Open-Label Study of Sacituzumab Govitecan (IMMU-132) in Subjects With Metastatic Solid Tumors
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Secondary ID [1]
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2019-000579-18
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Secondary ID [2]
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IMMU-132-11
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Universal Trial Number (UTN)
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Trial acronym
TROPiCS-03
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metastatic Solid Tumor
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Sacituzumab Govitecan-hziy
Experimental: Sacituzumab Govitecan-hziy - Participants with non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), endometrial cancer, or metastatic small cell lung cancer (mSCLC) will receive sacituzumab govitecan-hziy 10 mg/kg intravenously on Days 1 and 8 of a 21-day cycle until disease progression (PD), toxicity or withdrawal of consent.
Treatment: Drugs: Sacituzumab Govitecan-hziy
Administered intravenously
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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 (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator's Assessment
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Assessment method [1]
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ORR, is defined as the proportion of participants who achieve the best overall response, confirmed complete response (CR) or partial response (PR). Responses are based on the investigator-assessed tumor response using RECIST 1.1 criteria.
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Timepoint [1]
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Up to 3 years
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Secondary outcome [1]
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Objective Response Rate (ORR) According to RECIST 1.1 by Blinded Independent Central Review (BICR) Assessment
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Assessment method [1]
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ORR, is defined as the proportion of participants who achieve the best overall response, confirmed CR or PR. Responses are based on BICR assessment using RECIST 1.1 criteria.
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Timepoint [1]
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Up to 3 years
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Secondary outcome [2]
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Duration of Response (DOR) According to RECIST 1.1 by BICR
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Assessment method [2]
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DOR, is calculated as the date of the first evaluation showing documented response, either PR or CR, to the date of the first progression of disease (PD) or death from any cause, whichever comes first. Response are according to RECIST 1.1 by BICR
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Timepoint [2]
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Up to 3 years
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Secondary outcome [3]
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Clinical Benefit Rate (CBR) According to RECIST 1.1 by BICR
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Assessment method [3]
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CBR is defined as the proportion of participants who achieve the best overall response, CR + PR + stable disease (SD). Responses are according to RECIST 1.1 by BICR.
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Timepoint [3]
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Up to 3 years
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Secondary outcome [4]
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Progression-free Survival (PFS) According to RECIST 1.1 by BICR
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Assessment method [4]
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PFS, is defined as the time from first dose until objective tumor progression or death from any cause, whichever comes first. Responses are according to RECIST 1.1 by BICR
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Timepoint [4]
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Up to 3 years
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Secondary outcome [5]
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DOR According to RECIST 1.1 by Investigator's Assessment
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Assessment method [5]
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DOR, is calculated as the date of the first evaluation showing documented response, either PR or CR, to the date of the first PD or death from any cause, whichever comes first. Responses are based on the investigator-assessed tumor response using RECIST 1.1 criteria.
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Timepoint [5]
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Up to 3 years
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Secondary outcome [6]
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Clinical Benefit Rate (CBR) According to RECIST 1.1 by Investigator's Assessment
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Assessment method [6]
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CBR, is defined as the proportion of participants who achieve the best overall response, CR + PR + SD. Responses are based on the investigator-assessed tumor response using RECIST 1.1 criteria.
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Timepoint [6]
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Up to 3 years
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Secondary outcome [7]
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Progression-free Survival (PFS) According to RECIST 1.1 by Investigator's Assessment
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Assessment method [7]
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PFS, is defined as the time from first dose until objective tumor progression or death from any cause, whichever comes first. Responses are based on the investigator-assessed tumor response using RECIST 1.1 criteria.
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Timepoint [7]
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Up to 3 years
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Secondary outcome [8]
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Overall Survival (OS)
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Assessment method [8]
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Overall survival is defined as the interval from the first dose date of drug to death from any cause.
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Timepoint [8]
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Up to 3 years
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Secondary outcome [9]
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Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs)
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Assessment method [9]
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Timepoint [9]
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Up to 3 years
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Secondary outcome [10]
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Percentage of Participants Experiencing Clinically Significant Laboratory Abnormalities
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Assessment method [10]
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Timepoint [10]
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Up to 3 years
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Secondary outcome [11]
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Pharmacokinetic (PK) Parameter: Serum Concentration of Sacituzumab Govitecan-hziy
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Assessment method [11]
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Timepoint [11]
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First dose date up to last dose date plus 30 days (up to 3 years)
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Secondary outcome [12]
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Immunogenicity Assessment
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Assessment method [12]
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Number of participants who test positive for anti-drug antibodies to sacituzumab govitecan-hziy will be reported.
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Timepoint [12]
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First dose date up to last dose date plus 30 days (up to 3 years)
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Eligibility
Key inclusion criteria
Key
* Individuals with the following histologically documented metastatic (M1, Stage IV) or locally advanced solid tumors
* NSCLC (adenocarcinoma or SCC) that has progressed after prior platinum-based chemotherapy and programmed death-(ligand) 1 (PD-(L)1) directed therapy
* HNSCC that has progressed after prior platinum-based chemotherapy and anti-PD-(L)1 directed therapy No more than 3 prior lines of systemic treatment is allowed
* Endometrial carcinoma that has progressed after prior platinum-based chemotherapy and anti-PD-(L)1 directed therapy No more than 3 prior lines of systemic treatment is allowed.
* Extensive stage SCLC that has progressed after prior platinum-based chemotherapy and PD-(L)1 directed therapy. No more than one prior line of systemic treatment is allowed (re-challenge with the same initial regimen is not allowed)
* Eastern Cooperative Oncology Group (ECOG) Performance status score of 0 or 1
* Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study drug initiation
* Adequate hepatic and renal function (CrCl =30mL/min)
* Individual must have at least a 3-month life expectancy
* Have measurable disease by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
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Minimum age
18
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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
* Have had a prior anti-cancer biologic agent within 4 weeks prior to study Day 1 or have had prior chemotherapy, targeted small molecule therapy, radiation therapy within 2 weeks prior to Study Day 1
* Have not recovered (i.e., = Grade 1) from adverse events due to a previously administered agent
* Have previously received topoisomerase I inhibitors
* Have an active second malignancy
* Have known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Individuals with previously treated brain metastases may participate provided they have stable CNS disease for at least 4 weeks prior to the first dose of study drug and all neurologic symptoms have returned to baseline, have no evidence of new or enlarging brain metastases and are taking =20 mg/day of prednisone or its equivalent. All individuals with carcinomatous meningitis are excluded regardless of clinical stability
* Additional cohort specific exclusion criteria
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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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
Single group
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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
15/10/2019
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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
1/03/2025
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Actual
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Sample size
Target
165
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Southern Highlands Cancer Center - Bowral
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Macquarie University - North Ryde
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Calvary Mater Newcastle Hospital - Waratah
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Blacktown Hospital - Westmead
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Pindara Private Hospital - Benowa
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Mater Cancer Centre, Mater Misericordiae Limited - South Brisbane
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Lyell McEwin Hospital - Elizabeth Vale
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Monash Medical Centre, Monash Health - Clayton
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Recruitment hospital [9]
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The Andrew Love Cancer Centre, Geelong Hospital - Geelong
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Recruitment postcode(s) [1]
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2576 - Bowral
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Recruitment postcode(s) [2]
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2109 - North Ryde
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Recruitment postcode(s) [3]
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2298 - Waratah
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2145 - Westmead
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Recruitment postcode(s) [5]
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4217 - Benowa
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Recruitment postcode(s) [6]
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4101 - South Brisbane
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Recruitment postcode(s) [7]
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5112 - Elizabeth Vale
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Recruitment postcode(s) [8]
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3168 - Clayton
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Recruitment postcode(s) [9]
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3220 - Geelong
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Recruitment outside Australia
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United States of America
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Alaska
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Gilead Sciences
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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
The goal of this clinical study is to learn more about the study drug, sacituzumab govitecan-hziy, in participants with metastatic (cancer that has spread) solid tumors.
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Trial website
https://clinicaltrials.gov/study/NCT03964727
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Gilead Study Director
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Address
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Gilead Sciences
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03964727