A Study of the Effect of Food on the Pharmacokinetics of Single Dose RO5185426 And the Safety And Efficacy of Continuous Administration in Patients With BRAF V600E Mutation-Positive Metastatic Melanoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01264380
First received: December 20, 2010
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

This randomized, open-label, two period crossover study will evaluate the effect of food on the pharmacokinetics of a single dose of RO5185426 and the efficacy and safety of continuous administration in patients with BRAF V600E mutation-positive metastatic melanoma. Patients will be randomized to receive in a crossover design single oral doses of RO5185426 with or without food, with a 10-day washout period between doses. Following the crossover periods, patients will receive RO5185426 orally twice daily on a continuous basis until disease progression or unacceptable toxicity occurs.


Condition Intervention Phase
Malignant Melanoma
Drug: RO5185426
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I, Randomized, Open-label, Multi-center, Two Period Crossover Study to Investigate the Effect of Food on the Pharmacokinetics of a Single Oral Dose of RO5185426, Followed by Administration of 960 mg RO5185426 Twice Daily to BRAF V600E Positive Metastatic Melanoma Patients

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Effect of food (high fat meal) on the pharmacokinetics of vemurafenib: AUC, C max, C min, T max, t1/2, k el [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Best Overall Response Rate, tumour assessments according to RECIST criteria [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: January 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: RO5185426
Single oral dose, fasted
Experimental: 2 Drug: RO5185426
Single oral dose, with high fat meal
Experimental: C Drug: RO5185426
Continuous administration, orally twice daily

  Eligibility

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

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Histologically confirmed metastatic melanoma (Stage IV, American Joint Committee on Cancer)
  • Positive BRAF V600E mutation result determined by Cobas 4800 BRAF V600 Mutation Test
  • Previously treated patients must have failed at least one prior treatment regimen; if patients have received prior systemic treatments for metastatic melanoma, the time elapsed from previous therapy must be >/= 28 days; patients must have recovered fully from toxicities of all prior therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Evaluable disease (measurable for disease progression according to RECIST criteria)
  • Adequate hematological, renal and liver function

Exclusion Criteria:

  • Active CNS lesions
  • History of or known spinal cord compression or carcinomatous meningitis
  • Anticipated or ongoing administration of anti-cancer therapies other than those administered in this study
  • Previous malignancy within the past 5 years except for basal or squamous cell carcinoma of the skin, melanoma in-situ and carcinoma in-situ of the cervix
  • Previous treatment with BRAF inhibitor (sorafenib allowed) or MEK inhibitor
  • Refractory nausea or vomiting, malabsorption, external biliary shunt, or history of any type of gastrointestinal surgery that would preclude adequate absorption of study drug
  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: NCT01264380

Locations
United States, California
La Jolla, California, United States, 92037
Los Angeles, California, United States, 90095-1752
San Francisco, California, United States, 94115-1705
United States, Colorado
Aurora, Colorado, United States, 80045
United States, Indiana
Indianapolis, Indiana, United States, 46202
United States, Iowa
Iowa City, Iowa, United States, 52242
United States, Maryland
Baltimore, Maryland, United States, 21201
United States, New Hampshire
Lebanon, New Hampshire, United States, 03756
United States, South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Nashville, Tennessee, United States, 37232
United States, Texas
Dallas, Texas, United States, 75246
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: NCT01264380     History of Changes
Other Study ID Numbers: NP25396
Study First Received: December 20, 2010
Last Updated: March 3, 2014
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 July 24, 2014