A Study of RO5185426 in Patients With Metastatic Melanoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01248936
First received: November 24, 2010
Last updated: October 15, 2015
Last verified: October 2015

November 24, 2010
October 15, 2015
December 2010
October 2011   (final data collection date for primary outcome measure)
Incidence, type, and severity of AEs [ Time Frame: Through study completion, an average of 1 year ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT01248936 on ClinicalTrials.gov Archive Site
Incidence and nature of serious adverse events (SAEs) [ Time Frame: Through study completion, an average of 1 year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
A Study of RO5185426 in Patients With Metastatic Melanoma
A SINGLE ARM, OPEN LABEL, EXPANDED ACCESS STUDY OF RG7204 IN PREVIOUSLY TREATED PATIENTS WITH METASTATIC MELANOMA
This is an open-label, non-comparative, multicenter, expanded access study of RO5185426 in patients who have received prior systemic therapy for metastatic melanoma and who have no other satisfactory treatment options.
Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Malignant Melanoma
Drug: RO5185426
Experimental: Single Arm
Intervention: Drug: RO5185426
Frederick DT, Salas Fragomeni RA, Schalck A, Ferreiro-Neira I, Hoff T, Cooper ZA, Haq R, Panka DJ, Kwong LN, Davies MA, Cusack JC, Flaherty KT, Fisher DE, Mier JW, Wargo JA, Sullivan RJ. Clinical profiling of BCL-2 family members in the setting of BRAF inhibition offers a rationale for targeting de novo resistance using BH3 mimetics. PLoS One. 2014 Jul 1;9(7):e101286. doi: 10.1371/journal.pone.0101286. eCollection 2014.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
374
October 2011
October 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically confirmed metastatic melanoma with documented BRAF V600E mutation, determined by the cobas BRAF V600 mutation test
  • Patients with clinical evidence of disease progression during or after at least one prior systemic therapy for metastatic melanoma
  • Patients with either measurable or non-measurable disease
  • Adequate recovery from most recent systemic or local treatment for metastatic melanoma
  • Adequate organ funcion
  • For women of childbearing potential, agreement to the use of two acceptable methods of contraception, including one barrier method, during the study and for 6 months after discontinuation of RO5185426
  • For men with female partners of childbearing potential, agreement to use a latex condom, and to advise their female partner to use an additional method of contraception during the study and for 6 months after discontinuation of RO5185426
  • Negative serum or urine pregnancy test within 7 days of commencement of treatment in premenopausal women. Women who are either surgically sterile or have been post-menopausal for at least 1 year are eligible to participate in this study
  • Agreement not to donate blood or blood products during the study and for at least 6 months after disconinuation of RO5185426; for male patients, agreement not to donate sperm during the study and for at least 6 months after discontinuation of RO5185426

Exclusion Criteria:

  • Evidence of symptomatic CNS lesions as determined by investigator
  • Patients with a previous malignancy within the past 2 years are excluded except for patients with basal or squamous cell carcinoma (SCC) of the skin or carcinoma in-situ of the cervix. Isolated elevation in PSA in absence of radiographic evidence of metastatic prostate cancer is allowed
  • Pregnant or breast-feeding
  • Concurrent anti-tumor therapy
  • Any of the following within 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, hypertension not adequately controlled by current medications
  • Uncontrolled medical illness
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01248936
ML25597
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
October 2015

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