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A Study of Vemurafenib And GDC-0973 in Patients With BRAF-Mutation Positive Metastatic Melanoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01271803
First received: January 5, 2011
Last updated: March 2, 2015
Last verified: March 2015
History of Changes
  Purpose

This open-label, dose-escalation study of vemurafenib in combination with GDC-0973 will evaluate the safety, tolerability and pharmacokinetics in patients with BRAF V600 mutation-positive metastatic melanoma. Patients with previously untreated, BRAFV600E mutation-positive, locally advanced/unresectable or metastatic melanoma or those who have progressed on vemurafenib monotherapy immediately prior to enrolling in this trial are eligible. Patients will be assigned to different cohorts with escalating oral doses of vemurafenib and GDC-0973. The anticipated time on study treatment is until disease progression, unacceptable toxicity or any other discontinuation criterion.


Condition Intervention Phase
Malignant Melanoma
 Drug: GDC-0973
Drug: vemurafenib
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase IB, Open-Label, Dose-Escalation Study Evaluating the Safety, Tolerability and Pharmacokinetics of Vemurafenib in Combination With GDC-0973 When Administered in BRAFV600E Mutation-Positive Patients Previously Treated (But Without Prior Exposure to BRAF or MEK Inhibitor Therapy) or Previously Untreated for Locally- Advanced/Unresectable or Metastatic Melanoma or Those Who Have Progressed After Treatment With Vemurafenib

Resource links provided by NLM:

MedlinePlus related topics: Melanoma
Drug Information available for: Vemurafenib
U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Dose-limiting toxicity of vemurafenib in combination with GDC-0973 [ Time Frame: Cycle 1: Day 28 ] [ Designated as safety issue: Yes ]
  • Maximum tolerated dose of vemurafenib in combination with GDC-0973 [ Time Frame: Cycle 1: Day 28 ] [ Designated as safety issue: Yes ]
  • Safety (Incidence of adverse events) [ Time Frame: Approximately 2 years ] [ Designated as safety issue: No ]
  • Steady state plasma concentrations [ Time Frame: Cycle 1: Predose, Days 1, 2, 8, 14, 15, 16, 17; Cycle 2: Day 1, 8; Cycle 3: Day 8; at disease progression ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response [ Time Frame: Approximately 2 years ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: Approximately 2 years ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Approximately 2 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Approximately 2 years ] [ Designated as safety issue: No ]
  • Pharmacodynamics: Change in fluorodeoxyglucose-positron emission tomography (FDG-PET) [ Time Frame: At baseline; Cycle 1, Day 14: Cycle 2, Day 14; at disease progression ] [ Designated as safety issue: No ]
  • Pharmacodynamics: Immunohistochemical assessment of biopsies (MAP kinase) [ Time Frame: At baseline; Cycle 1: Day 14; at disease progression ] [ Designated as safety issue: No ]
Enrollment: 131
Study Start Date: February 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: GDC-0973
Oral repeated dose
Drug: vemurafenib
Oral repeated dose

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients, age >/=18 years
  • Patients with histologically confirmed metastatic melanoma (unresectable Stage IIIc and Stage IV, American Joint Committee on Cancer (AJCC) metastatic melanoma)
  • Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of </=1

  • Patients must

    1. be previously untreated for locally advanced/unresectable or metastatic melanoma or
    2. previously treated but without prior exposure to any BRAF or MEK inhibitor therapy or
    3. progressed on vemurafenib while participating in a Phase I (including clinical pharmacology studies), II, or III clinical study or EAP immediately prior to enrollment in this study or
    4. progressed on vemurafenib administered in a postmarketing setting immediately prior to enrollment in this study.
  • Life expectancy >/=12 weeks

Exclusion Criteria:

  • History of prior significant toxicity from another RAF or MEK pathway inhibitor requiring discontinuation of treatment
  • Palliative radiotherapy within 2 weeks prior to first dose of study drug treatment
  • Experimental therapy within 4 weeks prior to first dose of study drug treatment except vemurafenib
  • Major surgery within 4 weeks of first dose of study drug treatment or planning a major surgery during the study
  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: NCT01271803

Locations
United States, California
Los Angeles, California, United States, 90024
San Francisco, California, United States, 94143
Santa Monica, California, United States, 90025
United States, Colorado
Aurora, Colorado, United States, 80045
United States, Illinois
Chicago, Illinois, United States, 60637
United States, Indiana
Indianapolis, Indiana, United States, 46202
United States, Michigan
Detroit, Michigan, United States, 48201
United States, New York
New York, New York, United States, 10016
United States, Tennessee
Nashville, Tennessee, United States, 37232
Australia, Victoria
Melbourne, Victoria, Australia, 3002
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01271803     History of Changes
Other Study ID Numbers: NO25395
Study First Received: January 5, 2011
Last Updated: March 2, 2015
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on March 03, 2015