A Study Evaluating GDC-0980 Administered Once Daily in Patients With Refractory Solid Tumors or Non-Hodgkin's Lymphoma
An Open-label, Phase I, Dose-Escalation Study Evaluating the Safety, Tolerability, and Maximally Tolerated Dose of GDC-0980 Administered Once Daily in Patients With Refractory Solid Tumors and Non-Hodgkin's Lymphoma
2 other identifiers
interventional
121
2 countries
5
Brief Summary
This is an open-label, multicenter, Phase I study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of GDC-0980 administered to patients with incurable, locally advanced or metastatic solid malignancy or NHL that has progressed or failed to respond to at least one prior regimen or for which there is no standard therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2009
Longer than P75 for phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2009
CompletedStudy Start
First participant enrolled
March 1, 2009
CompletedFirst Posted
Study publicly available on registry
March 3, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedNovember 2, 2016
November 1, 2016
5.7 years
February 27, 2009
November 1, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Occurrence of adverse events
Length of study
Occurrence of dose-limiting toxicities
Length of study
PK parameters after doses of GDC-0980
Length of study
Occurrence of Grade 3 and 4 abnormalities in safety-related laboratory parameters and associated dose of GDC-0980
Length of study
Secondary Outcomes (1)
Best overall response, duration of objective response, and progression-free survival for patients with measurable disease
Length of study
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Histologically documented, incurable, locally advanced or metastatic solid malignancies, or NHL without leukemic phase, that has progressed despite standard of care therapy or for which there is no standard therapy of proven clinical benefit
- ECOG performance status of 0 or 1 at screening
- Evaluable or measurable disease per RECIST and/or the following: prostate cancer patients with non-measurable disease are eligible if they have two rising prostate-specific antigen (PSA) levels that meet the PSA Working Group criteria for progression prior to initiation of study treatment; ovarian cancer patients with non-measurable disease are eligible if they have two rising CA-125 levels greater than the ULN \>= 2 weeks apart prior to initiation of study treatment.
- Life expectancy \>=12 weeks
- Adequate hematologic and organ function within 14 days before initiation of GDC-0980
- Documented willingness to use an effective means of contraception for both men and women while participating in the study
You may not qualify if:
- Leptomeningeal disease as the only manifestation of the current malignancy
- History of Type 1 or 2 diabetes mellitus requiring regular medication
- Grade \>= 2 hypercholesterolemia or hypertriglyceridemia
- Ejection fraction that is \<50% or below the LLN (whichever is higher), as determined by echocardiogram or MUGA scan
- DLCO \< 50% of predicted value corrected for hemoglobin and alveolar volume prior to initiation of GDC-0980
- Malabsorption syndrome or other condition that would interfere with enteral absorption
- Known untreated malignancies of the brain or spinal cord, or treated brain metastases that are not radiographically stable for \>= 3 months
- Active congestive heart failure or ventricular arrhythmia requiring medication
- Active infection requiring IV antibiotics
- Requirement for any daily supplemental oxygen
- Uncontrolled hypomagnesemia
- Hypercalcemia requiring continued use of bisphosphonate therapy
- Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
- Uncontrolled ascites requiring frequent paracentesis
- Known HIV infection
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
Study Sites (5)
Unknown Facility
Chicago, Illinois, 60637, United States
Unknown Facility
Boston, Massachusetts, 02115, United States
Unknown Facility
New York, New York, 10065, United States
Unknown Facility
Nashville, Tennessee, 37203, United States
Unknown Facility
Sutton, SM2 5PT, United Kingdom
Related Publications (1)
Moein A, Jin JY, Wright MR, Alicke B, Wong H. Retrospective Assessment of Translational Pharmacokinetic-Pharmacodynamic Modeling Performance: A Case Study with Apitolisib, a Dual PI3K/mTOR Inhibitor. Drugs R D. 2024 Jun;24(2):155-167. doi: 10.1007/s40268-024-00459-5. Epub 2024 May 3.
PMID: 38700808DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mika Derynck, M.D.
Genentech, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2009
First Posted
March 3, 2009
Study Start
March 1, 2009
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
November 2, 2016
Record last verified: 2016-11