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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01991184
Registration number
NCT01991184
Ethics application status
Date submitted
18/11/2013
Date registered
25/11/2013
Date last updated
21/06/2022
Titles & IDs
Public title
A Study of GDC-0853 in Patients With Resistant B-Cell Lymphoma or Chronic Lymphocytic Leukemia.
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Scientific title
An Open-Label, Phase I, Dose-Escalation Study Evaluating The Safety And Tolerability Of Gdc-0853 In Patients With Relapsed Or Refractory B-Cell Non-Hodgkin's Lymphoma And Chronic Lymphocytic Leukemia
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Secondary ID [1]
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GO29089
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Lymphocytic Leukemia, Chronic, Diffuse Large B-Cell Lymphoma
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Cancer
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Leukaemia - Acute leukaemia
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Cancer
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0
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Leukaemia - Chronic leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - GDC-0853
Experimental: Dose-escalation -
Treatment: Drugs: GDC-0853
Multiple escalating doses
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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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Safety: Incidence of dose-limiting toxicities (DLTs) of GDC-0853
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Assessment method [1]
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Timepoint [1]
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Approximately 1 year
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Primary outcome [2]
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Safety: Maximum tolerated dose (MTD) of GDC-0853
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Assessment method [2]
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Timepoint [2]
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Approximately 1 year
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Secondary outcome [1]
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Safety: Incidence of adverse events
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Assessment method [1]
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Timepoint [1]
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Approximately 2 years
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Secondary outcome [2]
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Pharmacokinetics: Area under the concentration-time curve (AUC) of GDC-0853
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Assessment method [2]
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Timepoint [2]
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35 days
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Secondary outcome [3]
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Pharmacokinetics: Maximum concentration (Cmax) of GDC-0853
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Assessment method [3]
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Timepoint [3]
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35 days
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Secondary outcome [4]
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Objective response to GDC-0853
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Assessment method [4]
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Timepoint [4]
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Approximately 2 years
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Secondary outcome [5]
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Progression-free survival
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Assessment method [5]
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Timepoint [5]
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Approximately 2 years
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Eligibility
Key inclusion criteria
* Age >/= 18 years
* ECOG score of 0-1
* One of the following histologically-documented hematologic malignancies for which no effective standard therapy exists: indolent non Hodgkin's lymphoma (NHL), follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), or chronic lymphocytic leukemia (CLL)
* At least one site of disease that, as seen on CT scan, is > 1.5 cm in the greatest transverse diameter or > 1.0 cm in short axis diameter (except for patients with CLL)
* An available tumor specimen
* Adequate hematologic and organ function
* For female patients of childbearing potential and male patients with partners of childbearing potential, use of effective contraceptive(s) as defined by protocol for the duration of the study
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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
* Life expectancy < 12 weeks
* < 3 weeks since the last anti-tumor therapy, including chemotherapy, biologic, experimental, hormonal or radiotherapy (with the exception of leuprolide or similar medications for prostate cancer)
* Recent major surgical procedure or traumatic injury, or unhealed incisions or wounds
* Active infection requiring IV antibiotics
* Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis.
* Primary CNS malignancy or untreated/active CNS metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control)
* History of other malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin cancer, Stage I uterine cancer, or other cancers with a similar outcome
* Cardiovascular dysfunction, including ventricular dysrhythmias or risk factors for ventricular dysrhythmias
* Pregnancy, or lactation
* Any other diseases that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
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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 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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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
16/12/2013
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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
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Actual
8/03/2022
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Sample size
Target
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Accrual to date
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Final
24
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Recruitment in Australia
Recruitment state(s)
QLD,VIC,WA
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Recruitment hospital [1]
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Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology - Woolloongabba
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Recruitment hospital [2]
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Peter MacCallum Cancer Centre; Department of Haematology - Melbourne
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Recruitment hospital [3]
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Linear Clinical Research Limited - Nedlands
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Recruitment postcode(s) [1]
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4102 - Woolloongabba
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Recruitment postcode(s) [2]
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3002 - Melbourne
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Recruitment postcode(s) [3]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Missouri
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Country [3]
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United States of America
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State/province [3]
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Ohio
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Country [4]
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United States of America
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State/province [4]
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Oregon
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Country [5]
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United States of America
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State/province [5]
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Tennessee
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Country [6]
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United States of America
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State/province [6]
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Washington
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Genentech, Inc.
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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 open-label, Phase I study will evaluate the safety, tolerability, and pharmacokinetics of increasing doses of GDC-0853 in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia. In a dose-expansion part, GDC-0853 will be assessed in subsets of patients.
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Trial website
https://clinicaltrials.gov/study/NCT01991184
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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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Clinical Trials
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Address
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Genentech, Inc.
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
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/NCT01991184
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