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: August 26, 2014
Last verified: August 2014

January 5, 2011
August 26, 2014
February 2011
December 2016   (final data collection date for primary outcome measure)
  • 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 ]
  • 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 ]
  • Dose-limiting toxicity of RO5185426 in combination with GDC-0973 [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
  • Maximum tolerated dose of RO5185426 in combination with GDC-0973 [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
  • Safety (Incidence of adverse events) [ Time Frame: Approximately 2 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01271803 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
  • 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 ]
  • Steady state plasma concentrations [ Time Frame: Approximately 2 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of Vemurafenib And GDC-0973 in Patients With BRAF-Mutation Positive Metastatic Melanoma
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

This open-label, dose-escalation study of vemurafenib in combination with GDC-09 73 will evaluate the safety, tolerability and pharmacokinetics in patients with BRAF V600 mutation-positive metastatic melanoma. Patients with previously untrea ted, BRAFV600E mutation-positive, locally advanced/unresectable or metastatic me lanoma 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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Malignant Melanoma
  • Drug: GDC-0973
    Oral repeated dose
  • Drug: vemurafenib
    Oral repeated dose
Experimental: 1
Interventions:
  • Drug: GDC-0973
  • Drug: vemurafenib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
132
December 2016
December 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia
 
NCT01271803
NO25395
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP