Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Genentech, Inc.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01106599
First received: April 16, 2010
Last updated: November 19, 2014
Last verified: November 2014
  Purpose

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 sta ges: a dose-escalation stage (Stage I) followed by an expansion stage (Stage II

). Stage I will evaluate the safety, tolerability, and pharmacokinetics of incr easing doses of GDC-0623 administered orally on a 21 day on/7-day off dosing sch edule.


Condition Intervention Phase
Solid Cancers
Drug: GDC-0623
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Phase I, Dose Escalation Study Evaluating the Safety, Tolerability and Pharmacokinetics of GDC-0623 Administered Daily in Patients With Locally Advanced or Metastatic Solid Tumors

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Incidence and nature of dose-limiting toxicities (DLTs) [ Time Frame: Through study completion or early discontinuation ] [ Designated as safety issue: No ]
  • Incidence, nature, and severity of adverse events and serious adverse events, graded according to NCI CTCAE, v4.0 [ Time Frame: Through study completion or early discontinuation ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameters of GDC-0623 (total exposure, maximum and minimum plasma concentrations, time to maximum plasma concentration, elimination half-life) [ Time Frame: Through study completion or early discontinuation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response for patients with measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Through study completion or early discontinuation ] [ Designated as safety issue: No ]
  • Duration of objective response for patients with measurable disease according to RECIST [ Time Frame: Through study completion or early discontinuation ] [ Designated as safety issue: No ]
  • Progression-free survival (PFS) for patients with measurable disease according to RECIST [ Time Frame: Through study completion or early discontinuation ] [ Designated as safety issue: No ]

Estimated Enrollment: 62
Study Start Date: April 2010
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: GDC-0623
Repeating oral dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01106599

Contacts
Contact: Reference Study ID Number: MAP4834g www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

Locations
United States, California
Recruiting
Los Angeles, California, United States, 90033
Completed
Sacramento, California, United States, 95817
United States, Oklahoma
Completed
Oklahoma City, Oklahoma, United States, 73104
United States, Tennessee
Completed
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Genentech, Inc.
  More Information

No publications provided

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01106599     History of Changes
Other Study ID Numbers: MAP4834g, GO01327
Study First Received: April 16, 2010
Last Updated: November 19, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on November 24, 2014