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

NCT01226277 | Completed Phase 1

• 2 other identifiers: 4914gGO01306
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (3)

• Changes in vital signs, ECGs, and clinical laboratory results

  Throughout study or until early discontinuation

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

  Throughout study or until early discontinuation

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

  Throughout study or until early discontinuation

Secondary Outcomes (1)

• 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

Study Arms (1)

A

EXPERIMENTAL

Drug: GDC-0917

Interventions

GDC-0917 DRUG

Oral repeating dose

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (2)

Unknown Facility

Nashville, Tennessee, 37203, United States

Location

Unknown Facility

San Antonio, Texas, 98229, United States

Location

Study Officials

• Chia Portera, M.D., Ph.D.

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2010
• First Posted: October 22, 2010
• Study Start: October 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

US (2)