Roche trials database

Trial information

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

Status:

Completed

Protocol number:

NP25158

Sponsor:

Hoffmann-La Roche

Company division:

Pharmaceutical

Official Scientific Title:

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

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. Target sample size is 7.

Study phase:

I

Study type:

Interventional; Treatment; Non-randomized; Open label; Single group; Pharmacokinetics study

Conditions:

• Malignant Melanoma

Primary outcome:

1. Pharmacokinetics: Mass balance, metabolism, routes and rates of elimination of 14C-labeled RO5185426 Time frame: Day 14 to Day 36

Key secondary outcomes:

1. Safety and tolerability: Adverse events, laboratory parameters, ECG Time frame: from baseline to disease progression, withdrawal from study or death of any cause
2. Efficacy: Best Overall Response Rate (ORR): tumor assessments by CT/MRI/bone scan, according to RECIST criteria Time frame: from baseline to disease progression, withdrawal from study or death of any cause
3. Overall Survival Time frame: from baseline to death of any cause

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

Gender:

Males or Females

Age limits:

Min: 18 years Max: N/A (No limit)

Accepts healthy volunteers:

No

Anticipated start date:

July, 2010

Trial registration date:

30.06.2010

Date last updated:

16.05.2013

This trial was conducted at the following locations:

Switzerland

• ZÜRICH

Link to trial result