A Pharmacokinetic/Pharmacodynamic Study of RO5185426 in Previously Treated Patients With Metastatic Melanoma
NCT ID: NCT01107418
Last Updated: 2015-08-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
52 participants
INTERVENTIONAL
2010-05-31
2013-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
RO5185426
960 mg orally twice daily, from day 22 onward
RO5185426
dosage a) orally twice daily, days 1-15 (morning dose)
2
RO5185426
dosage b) orally twice daily, days 1-15 (morning dose)
RO5185426
960 mg orally twice daily, from day 22 onward
3
RO5185426
dosage c) orally twice daily, days 1-15 (morning dose)
RO5185426
960 mg orally twice daily, from day 22 onward
4
RO5185426
dosage d) orally twice daily, days 1-15 (morning dose)
RO5185426
960 mg orally twice daily, from day 22 onward
Interventions
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RO5185426
dosage b) orally twice daily, days 1-15 (morning dose)
RO5185426
dosage c) orally twice daily, days 1-15 (morning dose)
RO5185426
dosage d) orally twice daily, days 1-15 (morning dose)
RO5185426
960 mg orally twice daily, from day 22 onward
RO5185426
dosage a) orally twice daily, days 1-15 (morning dose)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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La Jolla, California, United States
San Francisco, California, United States
Stanford, California, United States
New Haven, Connecticut, United States
Chicago, Illinois, United States
Park Ridge, Illinois, United States
Sioux City, Iowa, United States
Omaha, Nebraska, United States
Columbus, Ohio, United States
East Providence, Rhode Island, United States
Charlottesville, Virginia, United States
Adelaide, South Australia, Australia
Melbourne, Victoria, Australia
Countries
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References
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Frederick DT, Salas Fragomeni RA, Schalck A, Ferreiro-Neira I, Hoff T, Cooper ZA, Haq R, Panka DJ, Kwong LN, Davies MA, Cusack JC, Flaherty KT, Fisher DE, Mier JW, Wargo JA, Sullivan RJ. Clinical profiling of BCL-2 family members in the setting of BRAF inhibition offers a rationale for targeting de novo resistance using BH3 mimetics. PLoS One. 2014 Jul 1;9(7):e101286. doi: 10.1371/journal.pone.0101286. eCollection 2014.
Lacouture ME, Duvic M, Hauschild A, Prieto VG, Robert C, Schadendorf D, Kim CC, McCormack CJ, Myskowski PL, Spleiss O, Trunzer K, Su F, Nelson B, Nolop KB, Grippo JF, Lee RJ, Klimek MJ, Troy JL, Joe AK. Analysis of dermatologic events in vemurafenib-treated patients with melanoma. Oncologist. 2013;18(3):314-22. doi: 10.1634/theoncologist.2012-0333. Epub 2013 Mar 1.
Other Identifiers
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NP25163
Identifier Type: -
Identifier Source: org_study_id
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