An Open-label, Phase I, Dose-escalation Study Evaluating GDC-0980 Administered Once Weekly in Patients With Refractory Solid Tumors and Non-hodgkin's Lymphoma

Genentech, Inc.0 sites38 target enrollmentMay 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: 38
Primary Endpoint: PK parameters after doses of GDC-0980
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

May 2009

End Date

July 2012

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
•A biopsy-accessible lesion from which tissue can be obtained safely
•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.
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening
•Life expectancy \>= 12 weeks
•Adequate hematologic and organ function within 28 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
•For patients participating in DCE-MRI assessments: at least one metastatic lesion measuring \>/= 3 cm in the liver or \>/= 2 cm elsewhere (lung and mediastinum lesions are ineligible) in at least one dimension (on CT scan)

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
•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
•Congenital long QT syndrome or screening QTc \> 470 msec
•Active congestive heart failure or ventricular arrhythmia requiring medication
•Ejection fraction that is \<50% or is below the LLN (whichever is higher), as determined by echocardiogram or MUGA scan
•Active infection requiring IV antibiotics
•Requirement for any daily supplemental oxygen

Arms & Interventions

1

Intervention: GDC-0980

Outcomes

Primary Outcomes

PK parameters after doses of GDC-0980

Time Frame: Length of study

Occurrence of adverse events

Time Frame: Length of study

Occurrence of dose-limiting toxicities

Time Frame: Length of study

Occurrence of Grade 3 and 4 abnormalities in safety-related laboratory parameters and associated dose of GDC-0980

Time Frame: Length of study

Secondary Outcomes

Best overall response, duration of objective response, and progression-free survival for patients with measurable disease according to RECIST(Length of study)
PET response for patients with detectable FDG tumor uptake at baseline(Length of study)