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

Genentech, Inc.0 sites121 target enrollmentMarch 2009

ConditionsNon-Hodgkin's Lymphoma, Solid Cancers

InterventionsGDC-0980

DrugsGDC-0980

Overview

Phase: Phase 1
Intervention: GDC-0980
Conditions: Non-Hodgkin's Lymphoma, Solid Cancers
Sponsor: Genentech, Inc.
Enrollment: 121
Primary Endpoint: Occurrence of adverse events
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2009

End Date

November 2014

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Genentech, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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