Phase IIb Study Evaluating the Safety and Efficacy of TXA127 in the Reduction of Incidence and Severity of Thrombocytopenia in Patients Receiving Combination Gemcitabine and Platinum Therapy for Ovarian, Fallopian Tube, or Peritoneal Carcinoma
This is a Phase IIb, multicenter, randomized, double-blind, placebo-controlled study
comparing safety and efficacy of two dose levels of TXA127 when administered during 6 cycles
of combination gemcitabine and platinum-based chemotherapy. This study intends to
investigate the effectiveness of TXA127 for the mitigation of severity and/or incidence of
thrombocytopenia, as well as safety when administered as a self-injected, subcutaneous
Females 18 years of age or older with a confirmed diagnosis of ovarian carcinoma who are
scheduled to undergo combination chemotherapy with gemcitabine and carboplatin or
gemcitabine and cisplatin will be considered for this study. Subjects may be chemotherapy
naïve, newly diagnosed, or post a single course of chemotherapy followed by a progression-
and treatment-free interval of at least 3 months, or post 2 or more previous courses of
chemotherapy after a progression- and treatment-free interval of at least 6 months.
Subjects will be randomized in a 1:1:1 ratio to one of the following three blinded treatment
groups: placebo, 100 ug/kg/day TXA127 and 300 ug/kg/day TXA127.
Treatment will be concurrent with up to six consecutive 21-day cycles of one of the
following gemcitabine and platin regimens:
- Intravenous cisplatin therapy at a dose of 30-50 mg/m2 given on Day 1 of the cycle
- Intravenous gemcitabine at a dose of 800 mg/m2 given on Day 1 after cisplatin and on
Day 8 of the cycle.
- Intravenous gemcitabine at a dose of 1000 mg/m2 given on Days 1 and 8 of the cycle
- Intravenous carboplatin AUC 4 given after gemcitabine on Day 1 of the cycle
TXA127 will be self-administered as a subcutaneous injection by the subject once daily on
Days 2-6 and 9-15 during each cycle of chemotherapy. Blood specimens will be drawn for
hematologic analysis on Days 1, 8 and 15 of each treatment cycle.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Chemotherapy Cycles During Which the Platelet Count Measures Below 50,000/mm3
Mean percentage of cycles with platelet counts below 50,000/mm3
During a maximum of six 3-week chemotherapy cycles
Gere S diZerega, MD
US Biotest, Inc.
United States: Food and Drug Administration
|Rush University Medical Center||Chicago, Illinois 60612-3824|
|Associates in Women's Health||Wichita, Kansas 67214|
|Schwartz Gynecologic Oncology, PLLC||Babylon, New York 11702|
|University of Southern Alabama Mitchell Cancer Institute||Mobile, Alabama 36604|
|USC - LAC Medical Center||Los Angeles, California 90033|
|University of California - Irvine, Chao Family Comprehensive Cancer Center||Orange, California 92868|