At a glance
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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
In Brief
A Phase 2 clinical trial evaluating TXA127 and Placebo for Thrombocytopenia and 3 related conditions. Completed, enrolled 34 participants across 6 sites.
Detailed Summary
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.
Study Details
Timeline
Interventions
Once daily subcutaneous injection of 100 ug/kg
Once daily subcutaneous injection of 300 ug/kg
Once daily subcutaneous injection of placebo