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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Malignant Melanoma

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Trial Information

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


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
- 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose-limiting toxicity of vemurafenib in combination with GDC-0973

Outcome Time Frame:

Cycle 1: Day 28

Safety Issue:

Yes

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

United States: Food and Drug Administration

Study ID:

NO25395

NCT ID:

NCT01271803

Start Date:

February 2011

Completion Date:

October 2014

Related Keywords:

  • Malignant Melanoma
  • Melanoma

Name

Location

Hinsdale, Illinois  60521
Fountain Valley, California  92708
Albany, New York  12208
Nashville, Tennessee  37203-1632
Flint, Michigan  48532
Denver, Colorado  
Indianapolis, Indiana