Clinical Trial: Proof-of-concept Study of Birinapant in Combination With Platinum Based Chemotherapy in Subjects With High Grade Serous Carcinomas
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: A Phase II, Single Center, Proof-of-concept Study of Birinapant in Combination With Platinum Based Chemotherapy in Participants With Advanced Newly Diagnosed or Recurrent High Grade Serous Carcinomas
Brief Summary: This clinical trial is a Phase II, single center, open label, proof-of-concept study evaluating the efficacy of birinapant in combination with platinum based chemotherapy. This pilot study is aimed at determining the efficacy of carboplatin and birinapant co-therapy in treating patients with advanced newly diagnosed or recurrent high grade serous carcinomas. Only bio-assay positive patients will be enrolled
Detailed Summary:
Participants with newly diagnosed disease will receive the following treatment Each participant will receive a total of six 21-day cycles of chemotherapy with treatment on day 1 and day 8. Patients will undergo an interval debulking surgery (IDS) after completing 3 cycles of chemotherapy followed by the remaining 3 cycles of chemotherapy.
Day 1:
Paclitaxel 175 mg/m2 IV over 3 hour Carboplatin AUC (area under the curve) 5 IV Birinapant 35 mg/m2 IV over 30 minutes
Day 8:
Birinapant 35 mg/m2 IV over 30 minutes Participants with recurrent disease will receive the following treatment
Day 1:
Carboplatin AUC (area under the curve) 5 IV Birinapant 35 mg/m2 IV over 30 minutes
Day 8:
Birinapant 35 mg/m2 IV over 30 minutes
Sponsor: Jonsson Comprehensive Cancer Center
Current Primary Outcome: Assess Progression-free survival (PFS) as measured by RECIST 1.1 [ Time Frame: 24 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Assess Overall Survival (OS) by measuring number of months from the initiation of birinapant to the date of death due to any cause [ Time Frame: 24 months ]Assess number of months from the initiation of birinapant to the date of death due to any cause
- Assess Response at interval debulking surgery for newly diagnosed patients as measured by RECIST 1.1 [ Time Frame: 24 months ]Assess Response at interval debulking surgery for newly diagnosed patients as measured by RECIST 1.1
- Assess levels of cIAP (cellular inhibitor of apoptosis) proteins in CA125 negative tumor cells measured by western blot. [ Time Frame: 24 months ]Assess levels of cIAP (cellular inhibitor of apoptosis) proteins in CA125 negative tumor cells measured by western blot.
- Assess percentage of cIAP (cellular inhibitor of apoptosis) positive/CA125 negative tumor cells measured by immunohistochemistry. [ Time Frame: 24 months ]Assess percentage of cIAP (cellular inhibitor of apoptosis) positive/CA125 negative tumor cells measured by immunohistochemistry
Original Secondary Outcome: Same as current
Information By: Jonsson Comprehensive Cancer Center
Dates:
Date Received: April 22, 2016
Date Started: January 2017
Date Completion: June 2020
Last Updated: January 20, 2017
Last Verified: October 2016