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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
Not Enrolling
Both
Malignant Melanoma

Thank you

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