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A Phase I, Open-label, Excretion Balance, Pharmacokinetic and Metabolism Study After Single Oral Dose of 14C-labeled RO5185426 in Previously Treated and Untreated Patients With Metastatic Melanoma


Phase 1
18 Years
N/A
Not Enrolling
Both
Malignant Melanoma

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Trial Information

A Phase I, Open-label, Excretion Balance, Pharmacokinetic and Metabolism Study After Single Oral Dose of 14C-labeled RO5185426 in Previously Treated and Untreated Patients With Metastatic Melanoma


Inclusion Criteria:



- Adult patients, >/= 18 years of age

- Histologically confirmed metastatic melanoma, surgically incurable and unresectable
Stage IIIc or IV (AJCC)

- Prior treatment for metastatic melanoma allowed; >/= 28 days must be elapsed since
previous systemic treatment prior to first administration of study drug

- Positive BRAF V600E mutation result (by Roche CoDx test)

- ECOG performance status 0-1

- Adequate hematologic, renal and liver function

- Body Mass Index (BMI) 18 to 32 kg/m2 inclusive

Exclusion Criteria:

- Active CNS lesions

- History of or known spinal cord compression, or carcinomatous meningitis

- Anticipated or ongoing administration of any anticancer therapies other than those
administered in this study

- Refractory nausea or vomiting, or other medical conditions that are capable of
altering the absorption, metabolism or elimination of the study drug

- Known clinically significant active infection

- Known HIV positivity or AIDS-related illness, active HBV, or active HCV

- 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

- Clinically significant cardiovascular disease or incident within the 6 months prior
to study drug administration

- Patients who have had at least one dose of study drug (RO5185426 or comparator) in a
clinical trial that includes RO5185426

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pharmacokinetics: Mass balance, metabolism, routes and rates of elimination of 14C-labeled RO5185426

Outcome Time Frame:

Day 14 to Day 36

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Switzerland: Swissmedic

Study ID:

NP25158

NCT ID:

NCT01164891

Start Date:

July 2010

Completion Date:

December 2012

Related Keywords:

  • Malignant Melanoma
  • Melanoma

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