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

NCT01106599 | Completed Phase 1

• 2 other identifiers: MAP4834gGO01327
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (3)

• Incidence and nature of dose-limiting toxicities (DLTs)

  Through study completion or early discontinuation

• Incidence, nature, and severity of adverse events and serious adverse events, graded according to NCI CTCAE, v4.0

  Through study completion or early discontinuation

• Pharmacokinetic parameters of GDC-0623 (total exposure, maximum and minimum plasma concentrations, time to maximum plasma concentration, elimination half-life)

  Through study completion or early discontinuation

Secondary Outcomes (3)

• Objective response for patients with measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)

  Through study completion or early discontinuation

• Duration of objective response for patients with measurable disease according to RECIST

  Through study completion or early discontinuation

• Progression-free survival (PFS) for patients with measurable disease according to RECIST

  Through study completion or early discontinuation

Study Arms (1)

A

EXPERIMENTAL

Drug: GDC-0623

Interventions

GDC-0623 DRUG

Repeating oral 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 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 \[Stage IID\])

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (4)

Unknown Facility

Los Angeles, California, 90033, United States

Location

Unknown Facility

Sacramento, California, 95817, United States

Location

Unknown Facility

Oklahoma City, Oklahoma, 73104, United States

Location

Unknown Facility

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Interventions

GDC-0623

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: April 16, 2010
• First Posted: April 20, 2010
• Study Start: April 1, 2010
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

US (4)