Safety/Efficacy Study of a Drug to Reduce Thrombocytopenia in Patients Receiving Chemotherapy for Ovarian, Fallopian Tube or Peritoneal Cancer

• Chemotherapy Cycles During Which the Platelet Count Measures Below 50,000/mm3 [ Time Frame: During a maximum of six 3-week chemotherapy cycles ] [ Designated as safety issue: No ]
  Mean percentage of cycles with platelet counts below 50,000/mm3
  
  

• Subjects With Platelet Counts Below 50,000/mm3 [ Time Frame: During a maximum of six 3-week chemotherapy cycles ] [ Designated as safety issue: No ]
  Number of subjects who experienced a platelet count below 50,000/mm3
  
  
• Treatment Cycles With Platelets Counts Below 25,000/mm3 [ Time Frame: During a maximum of six 3-week chemotherapy cycles ] [ Designated as safety issue: No ]
  Mean percentage of treatment cycles where platelets counts were below 25,000/mm3
  
  
• Chemotherapy Dose Intensity and Dose Density [ Time Frame: During a maximum of six 3-week chemotherapy cycles ] [ Designated as safety issue: No ]
  Mean percentage of cycles where projected (target) chemotherapy dose was maintained
  
  
• Lymphopenia as Determined by Lymphocyte Count [ Time Frame: During a maximum of six 3-week chemotherapy cycles ] [ Designated as safety issue: No ]
  Number of subjects with a treatment emergent adverse event of lymphopenia
  
  
• Neutropenia [ Time Frame: During a maximum of six 3-week chemotherapy cycles ] [ Designated as safety issue: No ]
  Number of subjects with a treatment emergent adverse event of neutropenia
  
  
• Anemia [ Time Frame: During a maximum of six 3-week chemotherapy cycles ] [ Designated as safety issue: No ]
  Number of subjects with a treatment emergent adverse event of anemia
  
  
• Mucositis [ Time Frame: During a maximum of six 3-week chemotherapy cycles ] [ Designated as safety issue: No ]
  Number of subjects with a treatment emergent adverse event of mucositis
  
  
• Alopecia [ Time Frame: During a maximum of six 3-week chemotherapy cycles ] [ Designated as safety issue: No ]
  Number of subjects with a treatment emergent adverse event of alopecia
  
  
• Rescue Treatment for Hematopoiesis and Mucositis [ Time Frame: During a maximum of six 3-week chemotherapy cycles ] [ Designated as safety issue: No ]

  Number of subjects with a treatment emergent adverse event of hematopoiesis and mucositis who received rescue treatment as determined by the administration of:

  1. Transfusions
  2. Filgrastim or Pegfilgrastim
  3. Erythropoietin
  4. Palifermin
  
  

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.