A Study of Vemurafenib And GDC-0973 in Patients With BRAF-Mutation Positive Metastatic Melanoma
This study is currently recruiting participants.
Verified June 2013 by Hoffmann-La Roche
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01271803
First received: January 5, 2011
Last updated: June 3, 2013
Last verified: June 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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: vemurafenib Drug: GDC-0973 |
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:
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 ]
| Estimated Enrollment: | 125 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: vemurafenib
Oral repeated dose
Drug: GDC-0973
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
- be previously untreated for locally advanced/unresectable or metastatic melanoma or
- previously treated but without prior exposure to any BRAF or MEK inhibitor therapy or
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01271803
Contacts
| Contact: Reference Study ID Number: NO25395 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, 90024 | |
| Recruiting | |
| San Francisco, California, United States, 94115 | |
| Recruiting | |
| Santa Monica, California, United States, 90025 | |
| United States, Colorado | |
| Recruiting | |
| Aurora, Colorado, United States, 80045 | |
| United States, Illinois | |
| Recruiting | |
| Chicago, Illinois, United States, 60637 | |
| United States, Indiana | |
| Recruiting | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Michigan | |
| Recruiting | |
| Detroit, Michigan, United States, 48201 | |
| United States, New York | |
| Recruiting | |
| New York, New York, United States, 10016 | |
| United States, Tennessee | |
| Recruiting | |
| Nashville, Tennessee, United States, 37232 | |
| Australia, Victoria | |
| Recruiting | |
| 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: | June 3, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |
ClinicalTrials.gov processed this record on June 13, 2013