Clinical trial · Interventional
A Pharmacokinetic and Metabolism Study of 14C-labeled RO5185426 on Patients With Metastatic Melanoma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Melanoma | Melanoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RO5185426 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Arm
- interventionNames
- Drug: RO5185426
Primary outcomes (13)
- measure
- Plasma RO5185426 Trough Concentrations on Days 15,16, and 17
- timeFrame
- Pre-dose on Days 15, 16 and 17
- measure
- Maximum Plasma Concentration of 14C-labeled RO5185426 (Cmax) in Both Blood and Plasma
- timeFrame
- 0 hour (prior to evening dose) on Day 14; 0 hour (pre dose), 1, 2, 4, 6, 12, 24, 36, 48, 72, 96, 168, 216, 312 hours post dose on Day 15, and then every 96 hour until recovery criteria met (maximum: 432 hours)
- description
- Collection of samples continued until the recovery criterion was met (radioactivity recovered from urine and feces ≤ 1 % of the radioactivity in the administered dose between any two successive 48-hour interval assessments). 14C-labeled RO5185426 given was equivalent to ≤1 millisieverts (mSv).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available