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.

Not yet recruiting

• Conditions: melanoma; skin cancer; 10040900

• Registration Number: NL-OMON33745
• Lead Sponsor: ovartis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2024-05-06

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

Age > 18 years;Histologically confirmed diagnosis of locally advanced or metastatic melanoma (for cutaneous melanoma American Joint Committee on Cancer (AJCC) Stage IIIb to IV, pathologic Stage III and IV for noncutaneous melanoma ), (see Appendix 1 for the AJCC Staging System for Cutaneous Melanoma).;Must have either archival tumor tissue or tumor that can be biopsied in order to determine whether it contains mutated or wild-type BRAF.;Evidence of measurable disease.;ECOG 0-1

Exclusion Criteria

Previous therapy with the following molecularly-targeted agents: MEK inhibitors VEGF or VEGFR inhibitors, RAF inhibitors;Patients with a history of primary central nervous system tumors or brain metastases or who have signs/symptoms attributable to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases.;Clinically significant cardiac disease including congestive heart failure.;Previous or concurrent malignancy except adequately treated basal cell or squamous cell skin cancer, in situ carcinoma of the cervix, or other solid tumor treated curatively, and without evidence of recurrence for at least 3 years prior to study entry.;Chronic anticoagulation therapy with full strength acetylsalicylic acid, warfarin, sodium, or heparin;History of thromboembolic or cerebrovascular events within the last 12 months, including transient ischemic attack, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism.;Prior acute or chronic pancreatitis of any etiology.;Prior intra or extrahepatic biliary obstruction within the previous 12 months, or history of malignant obstruction requiring a biliary stent, unless stably treated with no prior obstruction or blockage of the stent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified