Clinical trial NCT01253564: A Study of RO5185426 in Previously Treated Melanoma Patients With Brain Metastases
Official title: An Open-label, Pilot Study of RO5185426 in Previously Treated Metastatic Melanoma Patients With Brain Metastases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Malignant Melanoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-12-03
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This open-label study will assess the safety and efficacy of RO5185426 in previously treated metastatic melanoma patients with brain metastases. Patients will receive RO5185426 at a dose of 960 mg twice daily orally until disease progression or unacceptable toxicity occurs.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Metastatic melanoma (Stage IV, American Joint Committee on Cancer) with BRAF mutation (cobas 4800 BRAF V600 Mutation Test)
* Brain metastases for which surgical resection is not a treatment option
* Patients must have failed at least one previous treatment for brain metastases
* Requiring corticosteroids for symptom control
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Exclusion Criteria:

* Increasing corticosteroid dose during the 7 days prior to study entry
* Previous malignancy within the past 2 years, except for basal or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix
* Concurrent administration of any anticancer therapies other than those administered in the study
* Clinically significant cardiovascular disease or event within the 6 months prior to first dose of study drug

Primary outcomes:
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: From baseline up to last dose (0.1 to 11.3 months) plus 28 days
Secondary outcomes:
measure: Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) by Disease Site
timeFrame: Baseline, Week 4, Week 8 and thereafter every 8th week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months)
measure: Duration of Response by Disease Site
timeFrame: Baseline, Week 4, Week 8 and thereafter every 8th week until progressive disease or death (up to 16 months)
measure: Time to Response by Disease Site
timeFrame: Baseline, Week 4, Week 8 and thereafter every 8th week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months)
measure: Duration of Stable Disease (SD) by Disease Site
timeFrame: Baseline, Week 4, Week 8 and thereafter every 8th week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months)
measure: Time to New Lesion by Disease Site
timeFrame: Baseline, Week 4, Week 8 and thereafter every eighth week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months)
measure: Percentage of Participants With Disease Progression or Death by Disease Site
timeFrame: Baseline, Week 4, Week 8 and thereafter every 8th week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months)
measure: Progression Free Survival (PFS)
timeFrame: Baseline, Week 4, Week 8 and thereafter every eighth week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months)
measure: Percentage of Participants Who Died
timeFrame: Baseline up to end of the study and every 3 months during follow-up (up to 16 months)
measure: Overall Survival (OS)
timeFrame: From start of treatment up to end of the study and every 3 months during follow up (up to 16 months)
measure: Percentage of Participants With Improvement in Total Daily Dose of Corticosteroids
timeFrame: Baseline, every week during the first 8 weeks and every second week thereafter up to last dose (0.1 to 11.3 months) plus 28 days
measure: Percentage of Participants With Improvement in Total Daily Dose of Narcotic Pain Analgesic
timeFrame: Baseline, every week during the first 8 weeks and every second week thereafter up to last dose (0.1 to 11.3 months) plus 28 days
measure: Percentage of Participants With Improvement in Visual Analog Scale (VAS) Assessment of Pain
timeFrame: Baseline; Day 1 of Cycles 2-8 (28-day cycle) and at the end of study visit (up to 16 months)
measure: Percentage of Participants With Improvement in Physician's Assessment of Global Performance Status
timeFrame: Baseline, Day 1 of every 28-day cycle, at end of study and at the 28-day follow-up visit (up to 16 months)
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: CHUV; Departement d'Oncologie
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich; Dermatologische Klinik
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: