A Phase I, Randomized, Open-label, Multi-center, Multiple Dose Study to Investigate the Pharmacokinetics and Pharmacodynamics of RO5185426 Administered as 240 mg Tablets to Previously Treated BRAF V600E Positive Metastatic Melanoma Patients
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Malignant Melanoma
Both
Malignant Melanoma
Trial Information
A Phase I, Randomized, Open-label, Multi-center, Multiple Dose Study to Investigate the Pharmacokinetics and Pharmacodynamics of RO5185426 Administered as 240 mg Tablets to Previously Treated BRAF V600E Positive Metastatic Melanoma Patients
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Pharmacokinetics: RO5185426 plasma concentration
Outcome Time Frame:
multiple sampling days 1, 2, 9, 11, 15, 16 and 18; and on day 1 cycles 1-8 and every other cycle starting cycle 9
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
United States: Food and Drug Administration
Study ID:
NP25163
NCT ID:
NCT01107418
Start Date:
May 2010
Completion Date:
February 2013
Related Keywords:
- Malignant Melanoma
- Melanoma
Name | Location |
|---|---|
| Hinsdale, Illinois 60521 | |
| New Britain, Connecticut 06052 | |
| Bettendorf, Iowa 52722 | |
| Fountain Valley, California 92708 | |
| Cleveland, Ohio 44195 | |
| McLean, Virginia 22101 | |
| Omaha, Nebraska 68114 | |
| Providence, Rhode Island 02908 |
