C4471001 A Two-Part, Phase 1A/B, Open-Label, Multicenter Trial Evaluating Pharmacokinetics, Safety And Efficacy Of Pf 07284890 (Arry 461) In Participants With Braf V600 Mutant Solid Tumors With And Without Brain Involvement
Posted Date: Dec 15, 2021
- Investigator: Trisha Wise-Draper
- Specialties: Cancer, Oncology
- Type of Study: Drug
The purpose of this study is to assess the safety, tolerability, PK, and preliminary activity of PF-07284890 as a single agent and in combination with binimetinib in participants with BRAF V600-mutated advanced solid tumor malignancies with and without brain involvement. Efficacy will be measured by number of participants with dose limiting toxicities, number of participants with treatment emergent adverse events, number of participants with clinically significant change from baseline in laboratory abnormalities, number of dose interruptions, dose modifications, and discontinuations due to AEs, and overall response. There will be 3 different drugs used in this trial: PF-07284890, Binimetinib, and Midazolam.
Criteria:
Histologically Confirmed Diagnosis Of Advanced/Metastatic Solid Tumor Including Primary Brain Tumor. Documented Evidence Of A Braf V600 Mutation In Tumor Tissue Or Blood. Confirmation Of Availability Of Adequate Tumor Tissue For Submission To The Sponsor/Central Laboratory. Disease Progression Despite Prior Treatment And No Acceptable Alternative Treatment Options Available Unless Specified Below. Eastern Cooperative Oncology Group (Ecog) Performance Status Of 0 Or 1. No Brain Metastasis/Primary Brain Tumor Requiring Immediate Local Intervention. No History Of Or Current Leptomeningeal Metastases.No Any Other Active Malignancy Within 2 Years Prior To Enrollment. No Radiation Therapy To Visceral Metastases Within 14 Days Prior To Study Treatment. Wbrt Within 28 Days Prior To Study Treatment. No Systemic Anti-Cancer Therapy Or Small-Molecular Therapeutic(S) Within 2 Weeks Prior To Start Of Study Treatment; Antibody Based Agents Within 4 Weeks Prior To Start Of Study Treatment. No History Or Current Evidence Of Rvo Or Current Risk Factors For Rvo; History Of Retinal Degenerative Disease.
Keywords:
Phase 1, Solid Tumors, Brain
For More Information:
Uc Cancer Center
5135847698
cancer@uchealth.com