An Open-Label, Phase I, Dose-Escalation Study Evaluating the Safety, Tolerability and Pharmacokinetics of GDC-0917 Administered Daily in Patients With Refractory Solid Tumors or Lymphoma

Genentech, Inc.0 sites42 target enrollmentOctober 2010

ConditionsSolid Cancers

InterventionsGDC-0917

DrugsGDC-0917

Overview

Phase: Phase 1
Intervention: GDC-0917
Conditions: Solid Cancers
Sponsor: Genentech, Inc.
Enrollment: 42
Primary Endpoint: Changes in vital signs, ECGs, and clinical laboratory results
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 dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics (PK) of GDC-0917 in patients with refractory solid tumors or lymphoma.

Registry

clinicaltrials.gov

Start Date

October 2010

End Date

September 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 or cytologically documented, locally advanced or metastatic solid tumors or lymphoma for which standard therapy either does not exist or has proven ineffective or intolerable
•Life expectancy \>/= 12 weeks
•Adequate hematologic and end organ function
•For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use an effective form of contraception and to continue its use for the duration of the study.

Exclusion Criteria

•Clinically significant history of chronic liver disease, active hepatic infection, evidence of hepatic cirrhosis or Grade \>/= 2 liver dysfunction not due to hepatic metastases of cancer, current alcohol abuse, active infections with hepatitis B virus, or hepatitis C virus
•Grade \>/= 2 fever or associated constitutional symptoms, or a clinically significant systemic infection within the last month
•Autoimmune disease
•History of clinically significant pulmonary disease
•Need for chronic and continuous systemic or topical corticosteroids or immunosuppressive therapy within 2 weeks prior to study entry or anticipated need of continuous systemic corticosteroids or immunosuppressive therapy during study participation.
•Allergy or hypersensitivity to components of the GDC-0917 formulation
•Palliative radiotherapy within 2 weeks prior to first dose of study drug treatment in Cycle 1
•Experimental therapy within 4 weeks prior to first dose of study drug treatment in Cycle 1
•Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose of study drug treatment in Cycle 1, or anticipation of the need for major surgery during the course of study treatment
•Prior anti-cancer therapy within 4 weeks before the first dose of study drug treatment in Cycle 1

Arms & Interventions

A

Intervention: GDC-0917

Outcomes

Primary Outcomes

Changes in vital signs, ECGs, and clinical laboratory results

Time Frame: Throughout study or until early discontinuation

Incidence and nature of dose-limiting toxicities and adverse events of special interest

Time Frame: Throughout study or until early discontinuation

Incidence, nature, and severity of all adverse events and serious adverse events

Time Frame: Throughout study or until early discontinuation

Secondary Outcomes

Pharmacokinetic parameters of GDC-0917 (including total exposure, maximum and minimum serum concentration, time to maximum observed plasma concentration, elimination of half-life, accumulation at steady-state)(Throughout study or until early discontinuation)