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 ]

Assess Progression-free survival (PFS) as measured by RECIST 1.1


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