A Pharmacokinetic/Pharmacodynamic Study of RO5185426 in Previously Treated Patients With Metastatic Melanoma
This study is ongoing, but not recruiting participants.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01107418
First received: April 12, 2010
Last updated: April 29, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Malignant Melanoma |
Drug: RO5185426 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Pharmacokinetics: RO5185426 plasma concentration [ 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety and tolerability: Incidence of adverse events (AEs) [ Time Frame: throughout study ] [ Designated as safety issue: No ]
- Safety and tolerability: Assessment of routine laboratory values [ Time Frame: laboratory assessments every 3 weeks ] [ Designated as safety issue: No ]
- Efficacy: Best overall response (OR) [ Time Frame: tumor assessments every 2 cycles ] [ Designated as safety issue: No ]
- Efficacy: Overall survival (OS) [ Time Frame: event driven, assessed at study completion ] [ Designated as safety issue: No ]
| Enrollment: | 47 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: RO5185426
dosage a) orally twice daily, days 1-15 (morning dose)
Drug: RO5185426
960 mg orally twice daily, from day 22 onward
|
| Experimental: 2 |
Drug: RO5185426
dosage b) orally twice daily, days 1-15 (morning dose)
Drug: RO5185426
960 mg orally twice daily, from day 22 onward
|
| Experimental: 3 |
Drug: RO5185426
dosage c) orally twice daily, days 1-15 (morning dose)
Drug: RO5185426
960 mg orally twice daily, from day 22 onward
|
| Experimental: 4 |
Drug: RO5185426
dosage d) orally twice daily, days 1-15 (morning dose)
Drug: RO5185426
960 mg orally twice daily, from day 22 onward
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01107418
Locations
| United States, California | |
| La Jolla, California, United States, 92093 | |
| San Francisco, California, United States, 94143 | |
| Stanford, California, United States, 94305 | |
| United States, Connecticut | |
| New Haven, Connecticut, United States, 06510-3289 | |
| United States, Illinois | |
| Chicago, Illinois, United States, 60637 | |
| Niles, Illinois, United States, 60714 | |
| United States, Iowa | |
| Sioux City, Iowa, United States, 51108 | |
| United States, Nebraska | |
| Omaha, Nebraska, United States, 68114 | |
| United States, Ohio | |
| Columbus, Ohio, United States, 43219 | |
| United States, Rhode Island | |
| East Providence, Rhode Island, United States, 02915 | |
| United States, Virginia | |
| Charlottesville, Virginia, United States, 22908 | |
| Australia | |
| Adelaide, Australia, 5000 | |
| Melbourne, Australia, 3181 | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01107418 History of Changes |
| Other Study ID Numbers: | NP25163 |
| Study First Received: | April 12, 2010 |
| Last Updated: | April 29, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |
ClinicalTrials.gov processed this record on May 22, 2013