Clinical trial · Interventional
A Study to Evaluate RAF265, an Oral Drug Administered to Subjects With Locally Advanced or Metastatic Melanoma
A Phase I/II, Open-label, Dose Escalation Trial to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of RAF265 (CHIR-265)Administered Orally to Patients With Locally Advanced or 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)
The purpose of this study is to determine the safety profile, pharmacokinetics, pharmacodynamics and maximum tolerated dose of RAF265 in patients with locally advanced and metastatic melanoma. Phase II portion of study (dose expansion) has been cancelled with Amendment 7 as of Dec 2011.
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 |
|---|---|---|---|
| Metastatic Melanoma | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RAF265 | Drug | B-Raf/VEGFR-2 Inhibitor RAF265 | ALIAS |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- RAF265 - Arm 1
- description
- Patients received 10mg RAF265 as a once weekly dose until progressive disease was confirmed.
- interventionNames
- Drug: RAF265
- type
- EXPERIMENTAL
- label
- RAF265 - Arm 2
- description
- RAF265 is given as a single "PK run-in" dose, a single loading dose on day 1 of cycle 1, followed by once daily maintenance doses.
- interventionNames
- Drug: RAF265
- type
- EXPERIMENTAL
- label
- RAF265 - Arm 3
- description
- Patients were treated with once weekly dosing of RAF265
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Confirmed diagnosis of melanoma, locally advanced AJCC Stage IIIB to metastatic Stage IV 2. Measurable disease - at least one lesion measured in at least one dimension as ≥ 20 mm with conventional techniques or ≥ 10 mm with spiral computed tomography (CT) scan 3. ECOG performance status of 0 or 1 4. No concurrent anticancer or investigational therapy for at least 4 weeks prior to enrollment 5. No major surgery for at least 4 weeks prior to enrollment Exclusion Criteria: 1. Significant cardiac disease or other significant medical/psychiatric disease 2. History of primary central nervous system tumor or brain metastases 3. History of melena, hematemesis, or hemoptysis within the last 3 months 4. Previous therapy with certain molecularly targeted agents
References
Publications (0)
Data not yet available