A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0623 in Patients With Locally Advanced or Metastatic Solid Tumors

NCT ID: NCT01106599

Last Updated: 2016-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2014-08-31

Brief Summary

This is an open-label, multicenter, Phase I dose-escalation study to assess the safety, tolerability, and pharmacokinetics of GDC-0623 in patients with locally advanced or metastatic solid tumors. Patients will be enrolled in one of two stages: a dose-escalation stage (Stage I) followed by an expansion stage (Stage II). Stage I will evaluate the safety, tolerability, and pharmacokinetics of increasing doses of GDC-0623 administered orally on a 21 day on/7-day off dosing schedule.

Conditions

Solid Cancers

Study Design

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

Study Groups

A

Group Type: EXPERIMENTAL

GDC-0623

Intervention Type: DRUG

Repeating oral dose

Interventions

GDC-0623

Repeating oral dose

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Histologically or cytologically documented, locally advanced or metastatic solid tumors for which standard therapy either does not exist or has proven ineffective or intolerable
• Evaluable disease or disease measurable per RECIST
• Life expectancy >= 12 weeks
• Adequate hematologic and end organ function
• Agreement to use effective form of contraception for the duration of the study
• Consent to provide archival tissue
• For the cohort expansion stage (Stage II): Patients in this cohort must have had no more than four prior systemic therapies for cancer and must have KRAS mutant CRC (Stage II A and B), pancreatic cancer (Stage IIC, or KRAS mutant NSCLC [Stage IID])

Exclusion Criteria

• History of prior significant toxicity from a MEK pathway inhibitor requiring discontinuation of treatment
• History of parathyroid disorder or history of malignancy-associated hypercalcemia requiring therapy in the last 6 months
• History of retinal vein occlusion (RVO) or predisposing factors to RVO, including uncontrolled hypertension, uncontrolled diabetes, uncontrolled hyperlipidemia, and coagulopathy
• Evidence of visible retinal pathology considered a risk factor for retinal vein thrombosis
• History of glaucoma
• Palliative radiotherapy, experimental therapy, or anti-cancer therapy or major surgical procedure within a specified timeframe prior to first dose of study drug
• Current severe, uncontrolled systemic disease
• History of clinically significant cardiac dysfunction
• History of active gastrointestinal bleeding within 6 months prior to screening
• Clinically significant history of liver disease, current alcohol abuse, or current known active infection with HIV, or hepatitis B or C virus
• Active autoimmune disease
• Uncontrolled ascites
• Pregnancy, lactation, or breastfeeding
• Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms
• For the Exploratory PK Cohorts (Stage IB and Stage IC): Patients who have a history of or ongoing gastro-esophageal reflux disease or peptic ulcer, or who have gastric pathology or history of gastric surgery which could affect absorption of GDC-0623 from the stomach, will be excluded from these cohorts

• 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

Clinical Trials

Role: STUDY_DIRECTOR

Genentech, Inc.

Locations

Los Angeles, California, United States

Sacramento, California, United States

Oklahoma City, Oklahoma, United States

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

GO01327

Identifier Type: OTHER

Identifier Source: secondary_id

MAP4834g

Identifier Type: -

Identifier Source: org_study_id