A Study of RO5185426 in Previously Treated Melanoma Patients With Brain Metastases

NCT01253564 | Completed Phase 2 Results

• 1 other identifier: MO25653
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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.

Conditions

Malignant Melanoma

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Adverse Events (AEs)

  AE:any unfavorable and unintended sign, symptom, or disease associated with use of study drug, regardless of relation to study drug. Pre-existing conditions that worsened and laboratory or clinical tests that resulted in change in treatment or discontinuation from study drug were reported as AEs. Serious AE: resulted in death, life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect or was medically significant. Grade-1:discomfort but no disruption of normal daily activity. Grade-2:discomfort sufficient to reduce or affect daily activity,no intervention indicated.Grade-3:inability to perform normal daily activity,intervention indicated.Grade-4:immediate threat to life or leading to permanent mental or physical condition that prevented performing normal daily activities.Grade 5: death. Any AE included participants with serious and non-serious AE.

  From baseline up to last dose (0.1 to 11.3 months) plus 28 days

Secondary Outcomes (13)

• Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) by Disease Site

  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)

• Duration of Response by Disease Site

  Baseline, Week 4, Week 8 and thereafter every 8th week until progressive disease or death (up to 16 months)

• Time to Response by Disease Site

  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)

• Duration of Stable Disease (SD) by Disease Site

  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)

• Time to New Lesion by Disease Site

  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)

Study Arms (1)

Single Arm

EXPERIMENTAL

Drug: RO5185426

Interventions

RO5185426 DRUG

960 mg b.i.d. orally

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (2)

CHUV; Departement d'Oncologie

Lausanne, 1011, Switzerland

Location

Universitätsspital Zürich; Dermatologische Klinik

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-LaRoche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2010
• First Posted: December 3, 2010
• Study Start: November 22, 2010
• Primary Completion: March 14, 2012
• Study Completion: March 14, 2012
• Last Updated: July 31, 2017
• Results First Posted: August 7, 2015

Record last verified: 2017-06

Locations

CH (2)