Anemia Clinical Trial
Official title:
Ph IIb Study Evaluating the Safety & 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 research study will investigate the safety and effectiveness of two different dose levels of a new, unapproved drug to be given along with the chemotherapy regimens gemcitabine and carboplatin or gemcitabine and cisplatin prescribed to women for the treatment of ovarian cancer. This experimental drug is called TXA127 and is being tested for effectiveness to see if it will help reduce some of the side effects of the chemotherapy, primarily low blood platelet levels that lead to excess bleeding. This study also intends to test the safety of TXA127 when given as an injection under the skin on a daily basis concurrently with up to 6 cycles of the prescribed chemotherapy.
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
solution.
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:
Regimen A
- 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.
Regimen B
- 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.
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