A Study of RO5185426 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:
NCT01307397
First received: February 17, 2011
Last updated: October 13, 2014
Last verified: October 2014

February 17, 2011
October 13, 2014
March 2011
January 2015   (final data collection date for primary outcome measure)
Safety: Incidence of adverse events [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT01307397 on ClinicalTrials.gov Archive Site
Overall Response Rate, tumor assessments according to RECIST criteria [ Time Frame: 22 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
A Study of RO5185426 in Patients With Metastatic Melanoma
An Open-label, Multicenter Study to Assess the Safety of RO5185426 in Patients With Metastatic Melanoma

This open-label, multicenter study will evaluate the safety and efficacy of RO51 85426 in patients with BRAF V600 mutation-positive, surgically incurable and unr esectable stage IIIC or IV metastatic melanoma. Eligible patients will receive R O5185426 (960 mg twice daily orally) until disease progression or unacceptable t oxicity occurs, with a safety follow-up of 24 months after discontinuation of th e study drug.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Malignant Melanoma
Drug: RO5185426
960 mg twice daily orally
Experimental: Single Arm
Intervention: Drug: RO5185426
Larkin J, Del Vecchio M, Ascierto PA, Krajsova I, Schachter J, Neyns B, Espinosa E, Garbe C, Sileni VC, Gogas H, Miller WH Jr, Mandalà M, Hospers GA, Arance A, Queirolo P, Hauschild A, Brown MP, Mitchell L, Veronese L, Blank CU. Vemurafenib in patients with BRAF(V600) mutated metastatic melanoma: an open-label, multicentre, safety study. Lancet Oncol. 2014 Apr;15(4):436-44. doi: 10.1016/S1470-2045(14)70051-8. Epub 2014 Feb 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
3255
January 2015
January 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients, >/= 16 years of age
  • Histologically confirmed metastatic melanoma (surgically incurable and unresectable stage IIIC or stage IV; AJCC) with BRAF V600 mutation determined by Cobas 4800 BRAF Mutation Test
  • Patients may or may not have received prior systemic therapy for metastatic melanoma
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Adequate hematologic, renal and liver function

Exclusion Criteria:

  • Evidence of symptomatic CNS lesions, use of steroids or anti-seizure medications for treatment of brain metastases prior to the first administration of RO5185426
  • Previous malignancy (other than melanoma) within the past 2 years, except for treated and controlled basal or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix
  • Concurrent administration of any anti-cancer therapies other than those administered in the study
  • Clinically significant cardiovascular disease or event within the 6 months prior to first administration of study drug
  • Refractory nausea or vomiting, external biliary shunt, or significant bowel resection that would preclude adequate absorption
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Albania,   Argentina,   Australia,   Austria,   Belgium,   Bosnia and Herzegovina,   Brazil,   Bulgaria,   Canada,   Colombia,   Croatia,   Czech Republic,   Denmark,   Ecuador,   Estonia,   Finland,   Germany,   Greece,   Hungary,   India,   Ireland,   Israel,   Italy,   Korea, Republic of,   Latvia,   Lithuania,   Macedonia, The Former Yugoslav Republic of,   Mexico,   Netherlands,   Norway,   Peru,   Poland,   Portugal,   Romania,   Russian Federation,   Serbia,   Slovakia,   Slovenia,   South Africa,   Spain,   Sweden,   Switzerland,   Turkey,   United Kingdom
 
NCT01307397
MO25515
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
October 2014

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