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An Open-label, Multicenter Study to Assess the Safety of RO5185426 in Patients With Metastatic Melanoma


Phase 3
16 Years
N/A
Open (Enrolling)
Both
Malignant Melanoma

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Trial Information

An Open-label, Multicenter Study to Assess the Safety of RO5185426 in Patients With Metastatic Melanoma


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

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:

Safety: Incidence of adverse events

Outcome Time Frame:

approximately 4 years

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Greece: Ministry of Health

Study ID:

MO25515

NCT ID:

NCT01307397

Start Date:

March 2011

Completion Date:

March 2015

Related Keywords:

  • Malignant Melanoma
  • Melanoma

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