Text Size

A Pharmacokinetic Study of RO5185426 in Combination With a Drug Cocktail in Patients With Metastatic Melanoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01001299
First received: October 21, 2009
Last updated: May 23, 2013
Last verified: May 2013
History of Changes

October 21, 2009
May 23, 2013
November 2009
August 2013   (final data collection date for primary outcome measure)
Pharmacokinetics: blood concentration levels of RO5185426 and of the 5 drugs of the drug cocktail and their metabolites [ Time Frame: Multiple sampling, days 1-25 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01001299 on ClinicalTrials.gov Archive Site
  • Efficacy: best overall response rate, duration of response, time to response, progression-free survival, overall survival [ Time Frame: Tumour assessment on day 28 and every 8 weeks thereafter ] [ Designated as safety issue: No ]
  • Safety and tolerability: AEs, laboratory parameters [ Time Frame: Throughout study, laboratory assessments on days 1, 2, 5, 18, 20, 22 and every 1-2 cycles thereafter ] [ Designated as safety issue: No ]
  • Efficacy: best overall response rate, duration of response, time to response, progression-free survival, overall survival [ Time Frame: Tumour assessment on day 28 and every 8 weeks thereafter ] [ Designated as safety issue: No ]
  • Safety and tolerability: AEs, laboratory parameters [ Time Frame: Throughout study, laboratory assessments on days 1, 3, 5, 19, 20, 22 and every 1-2 cycles thereafter ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Pharmacokinetic Study of RO5185426 in Combination With a Drug Cocktail in Patients With Metastatic Melanoma
A Multi-center, Open-label, Study to Investigate the Pharmacokinetic Interaction of RO5185426 With a "Cocktail" of Five Probe Drugs for CYP450 Dependent Metabolism in Patients With Previously Treated and Untreated Metastatic Melanoma

This open-label single-arm study will evaluate the effect of RO5185426 [RG7204; PLEXXIKON: PLX4032] on the pharmacokinetics of five CYP450 substrates (caffeine, warfarin + vitamin K, omeprazole, dextromethorphan, midazolam) administered as a drug cocktail to patients with metastatic melanoma. The study will also evaluate efficacy and safety of RO5185426. On day 1, patients will receive the drug cocktail. On days 6 to 19, patients will receive RO5185426 twice daily. On day 20, patients will receive RO5185426 and the drug cocktail and on days 21 to 25, patients will receive RO5185426. Assessments will be made at regular intervals during the dosing periods and at follow-up. Patients may continue on study treatment (RO5185426) until the development of progressive disease or unacceptable toxicity. Target sample size <50.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Malignant Melanoma
  • Drug: RO5185426
    960 mg orally twice daily
  • Drug: Drug cocktail
    Drug cocktail (caffeine, warfarin + vitamin K, omeprazole, dextromethorphan, midazolam) orally once daily, day 1 and day 20
Experimental: Single arm
Interventions:
  • Drug: RO5185426
  • Drug: Drug cocktail
Su F, Viros A, Milagre C, Trunzer K, Bollag G, Spleiss O, Reis-Filho JS, Kong X, Koya RC, Flaherty KT, Chapman PB, Kim MJ, Hayward R, Martin M, Yang H, Wang Q, Hilton H, Hang JS, Noe J, Lambros M, Geyer F, Dhomen N, Niculescu-Duvaz I, Zambon A, Niculescu-Duvaz D, Preece N, Robert L, Otte NJ, Mok S, Kee D, Ma Y, Zhang C, Habets G, Burton EA, Wong B, Nguyen H, Kockx M, Andries L, Lestini B, Nolop KB, Lee RJ, Joe AK, Troy JL, Gonzalez R, Hutson TE, Puzanov I, Chmielowski B, Springer CJ, McArthur GA, Sosman JA, Lo RS, Ribas A, Marais R. RAS mutations in cutaneous squamous-cell carcinomas in patients treated with BRAF inhibitors. N Engl J Med. 2012 Jan 19;366(3):207-15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
22
August 2013
August 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patient >/= 18 years of age
  • Malignant melanoma (Stage IV, AJCC)
  • Patients who are treatment-naive or have received prior systemic treatments for metastatic melanoma. Time elapsed between previous treatment for metastatic disease and first administration of study drug must be at least 28 days
  • Positive tested for BRAF mutation
  • Patients must not be poor metabolizers of CYP450 enzymes 2C9, 2C19, or 2D6 as determined by genotyping
  • Measurable disease by RECIST criteria
  • Negative pregnancy test; for fertile men and women, effective contraception during treatment and for 6 months after completion

Exclusion Criteria:

  • Active CNS lesions on CT/MRI within 28 days prior to enrollment
  • History of known spinal cord compression, or carcinomatous meningitis
  • Severe cardiovascular disease within 6 months prior to study
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01001299
NP22676
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
May 2013

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