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 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