NCT02950064

A Study to Determine the Safety of BTP-114 for Treatment in Patients With Advanced Solid Tumors With BRCA Mutations

Escalation Study of BTP-114 in Patients With Advanced Solid Tumors and BRCA or DNA Repair Mutation

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 95 (estimated)
• Sponsor: Placon Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1, Open-label, multicenter Dose Escalation study of BTP-114, a novel platinum product, in patients with advanced solid tumors and BRCA or other DNA repair mutation. This clinical study is comprised of 2 sequential parts: Part 1 (Dose Escalation) and Part 2 (Expansion). The purpose of this study is to evaluate the safety, pharmacokinetics and the anti-cancer activity of BTP-114.

Conditions

• Pancreatic Neoplasms
• Ovarian Neoplasms
• Breast Neoplasms
• Prostatic Neoplasms

Interventions

Type	Name	Description
DRUG	BTP-114	Part 1 (Escalation) IV treatment of BTP-114 in 21-day cycles. Doses will be increased in sequential cohorts until the maximum tolerated dose is determined which will lead to the recommended phase 2 dose Part 2 (Expansion) 5 cohorts of patients will be treated at the RP2D of IV BTP-114 in 21-day cycles for the tumor types pancreatic cancer, castration-resistant prostate cancer, ovarian cancer, triple-negative breast cancer and deoxyribonucleic acid (DNA) repair mutation-positive advanced solid tumors.

Timeline

• Start date: 2016-09-01
• Primary completion: 2020-04-01
• Completion: 2020-08-01
• First posted: 2016-10-31
• Last updated: 2019-01-14

Locations

8 sites across 1 country: United States