A Study of the Effect of Food on the Pharmacokinetics of Single Dose RO5185426 And the Safety And Efficacy of Continuous Administration in Patients With BRAF V600E Mutation-Positive Metastatic Melanoma
NCT ID: NCT01264380
Last Updated: 2016-11-02
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE1
16 participants
INTERVENTIONAL
2011-01-31
2013-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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1
RO5185426
Single oral dose, fasted
2
RO5185426
Single oral dose, with high fat meal
C
RO5185426
Continuous administration, orally twice daily
Interventions
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RO5185426
Single oral dose, fasted
RO5185426
Single oral dose, with high fat meal
RO5185426
Continuous administration, orally twice daily
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed metastatic melanoma (Stage IV, American Joint Committee on Cancer)
* Positive BRAF V600E mutation result determined by Cobas 4800 BRAF V600 Mutation Test
* Previously treated patients must have failed at least one prior treatment regimen; if patients have received prior systemic treatments for metastatic melanoma, the time elapsed from previous therapy must be \>/= 28 days; patients must have recovered fully from toxicities of all prior therapy
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Evaluable disease (measurable for disease progression according to RECIST criteria)
* Adequate hematological, renal and liver function
Exclusion Criteria
* History of or known spinal cord compression or carcinomatous meningitis
* Anticipated or ongoing administration of anti-cancer therapies other than those administered in this 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
* Previous treatment with BRAF inhibitor (sorafenib allowed) or MEK inhibitor
* Refractory nausea or vomiting, malabsorption, external biliary shunt, or history of any type of gastrointestinal surgery that would preclude adequate absorption of study drug
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
Los Angeles, California, United States
San Francisco, California, United States
Aurora, Colorado, United States
Indianapolis, Indiana, United States
Iowa City, Iowa, United States
Lebanon, New Hampshire, United States
Charleston, South Carolina, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
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.
Other Identifiers
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NP25396
Identifier Type: -
Identifier Source: org_study_id