A Pharmacokinetic and Metabolism Study of 14C-labeled RO5185426 on Patients With Metastatic Melanoma

NCT ID: NCT01164891

Last Updated: 2023-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2012-12-31

Brief Summary

This open-label, non-randomized study will assess the mass balance, metabolism, routes and rates of elimination as well as efficacy and safety of RO5185426 (RG7204; PLEXXIKON; PLX4032) in previously treated or untreated patients with metastatic melanoma. Patients will receive continuous twice daily oral treatment with RO5185426. On Day 15, a 14C-labeled dose will be administered. Anticipated time on study treatment is until disease progression occurs.

Conditions

Malignant Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Arm

Group Type: EXPERIMENTAL

RO5185426

Intervention Type: DRUG

Continuous oral dosing b.i.d. , on Day 15 a C isotope labeled dose will be administered

Interventions

RO5185426

Continuous oral dosing b.i.d. , on Day 15 a C isotope labeled dose will be administered

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

NP25158

Identifier Type: -

Identifier Source: org_study_id