A Pharmacokinetic/Pharmacodynamic Study of RO5185426 in Previously Treated Patients With Metastatic Melanoma

Completed · Phase 1

Conditions studied: Malignant Melanoma

In brief

This open-label study will assess the pharmacokinetics, efficacy and safety of RO5185426 administered as 240mg tablets in previously treated patients with metastatic melanoma. Patients will be randomized to receive one of four dose-levels of RO5185426 \[RG7204; PLEXXIKON; PLX4032\] orally twice daily on days 1 to 15 (morning dose). Starting on day 22, treatment with RO5185426 may be resumed at a dose of 960 mg twice daily and continued until disease progression. Target sample size is \<100 patients.

Key facts

Study ID

NCT01107418

Run by

Hoffmann-La Roche

People needed

52

Starts

2010-05-01

Expected to finish

2013-02-01

Last updated by the study team

2015-08-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• adult patients, >/=18 years of age
• histologically confirmed metastatic melanoma, stage IIIc or IV (AJCC)
• failure of at least one prior standard of care regimen
• positive for BRAF V600E mutation (by Roche CoDx BRAF mutation assay)
• ECOG performance status 0 or 1
• adequate hematologic, renal and liver function

You may not qualify if…

• active CNS lesions on CT/MRI within 28 days prior to enrollment
• history of spinal cord compression o carcinomatous meningitis
• anticipated or ongoing anti-cancer therapies other than those administered in this study
• previous treatment with BRAF inhibitor (sorafenib allowed) or MEK inhibitor
• severe cardiovascular disease within 6 months prior to study
• previous malignancy within the past 5 years except for basal or squamous cell carcinoma of the skin, melanoma in-situ and carcinoma in-situ of the cervix

Where it is running

• Study site — La Jolla, California, United States
• Study site — San Francisco, California, United States
• Study site — Stanford, California, United States
• Study site — New Haven, Connecticut, United States
• Study site — Chicago, Illinois, United States
• Study site — Park Ridge, Illinois, United States
• Study site — Sioux City, Iowa, United States
• Study site — Omaha, Nebraska, United States
• Study site — Columbus, Ohio, United States
• Study site — East Providence, Rhode Island, United States
• Study site — Charlottesville, Virginia, United States
• Study site — Adelaide, South Australia, Australia
• Study site — Melbourne, Victoria, Australia

Full record on ClinicalTrials.gov

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