A Study Evaluating the Safety, Tolerability and Pharmacokinetics of GDC-0917 Administered to Patients With Refractory Solid Tumors or Lymphoma

NCT ID: NCT01226277

Last Updated: 2016-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2012-09-30

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.

Conditions

Solid Cancers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

Group Type: EXPERIMENTAL

GDC-0917

Intervention Type: DRUG

Oral repeating dose

Interventions

GDC-0917

Oral repeating dose

Intervention Type: DRUG

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
• All acute drug-related toxicities must have resolved prior to study entry, except for alopecia and Grade 1 neuropathy
• Current severe, uncontrolled systemic disease excluding cancer
• History of clinically significant cardiac dysfunction
• History of malabsorption or other condition that would interfere with enteral absorption
• Any history of active GI bleeding within the past 6 months prior to screening
• Known HIV infection
• Uncontrolled ascites, due to diseases other than cancer, requiring weekly large-volume paracentesis for 3 consecutive weeks prior to enrollment
• Pregnancy, lactation, breastfeeding or unwillingness to use birth control during the study and for 3 months after the last dose of GDC-0917
• Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chia Portera, M.D., Ph.D.

Role: STUDY_DIRECTOR

Genentech, Inc.

Locations

Nashville, Tennessee, United States

San Antonio, Texas, United States

Countries

United States

Other Identifiers

GO01306

Identifier Type: OTHER

Identifier Source: secondary_id

4914g

Identifier Type: -

Identifier Source: org_study_id