Clinical Trial: Study of Drug to Reduce Thrombocytopenia in Patients Receiving Chemo for Ovarian, Fallopian Tube or Peritoneal Cancer
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
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 Ovaria
Brief 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.
Detailed Summary:
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
Sponsor: Tarix Pharmaceuticals
Current Primary Outcome: Chemotherapy Cycles During Which the Platelet Count Measures Below 50,000/mm3 [ Time Frame: During a maximum of six 3-week chemotherapy cycles ]
Mean percentage of cycles with platelet counts below 50,000/mm3
Original Primary Outcome: The severity and incidence of thrombocytopenia as determined by the number of patient chemotherapy cycles during which the platelet count measures below 50,000/mm3 (NCI Grade 3 and/or 4 thrombocytopenia). [ Time Frame: During a maximum of six 3-week chemotherapy cycles ]
Current Secondary Outcome:
- Subjects With Platelet Counts Below 50,000/mm3 [ Time Frame: During a maximum of six 3-week chemotherapy cycles ]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 ]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 ]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 ]Number of subjects with a treatment emergent adverse event of lymphopenia
- Neutropenia [ Time Frame: During a maximum of six 3-week chemotherapy cycles ]Number of subjects with a treatment emergent adverse event of neutropenia
- Anemia [ Time Frame: During a maximum of six 3-week chemotherapy cycles ]Number of subjects with a treatment emergent adverse event of anemia
- Mucositis [ Time Frame: During a maximum of six 3-week chemotherapy cycles ]Number of subjects with a treatment emergent adverse event of mucositis
- Alopecia [ Time Frame: During a maximum of six 3-week chemotherapy cycles ]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 ]
Number of subjects with a treatment emergent adverse event of hematopoiesis and mucositis who received rescue treatment as determined by the administration of:
- Transfusions
- Filgrastim or Pegfilgrastim
- Erythropoietin
- Palifermin
Original Secondary Outcome:
- The severity and incidence of thrombocytopenia as determined by the number of patients who experience a platelet count below 50,000/mm3 (NCI Grade 3 and/or 4 thrombocytopenia). [ Time Frame: During a maximum of six 3-week chemotherapy cycles ]
- The severity and incidence of thrombocytopenia as determined by absolute nadir and time to recovery of platelet count for each treatment cycle and study subject. [ Time Frame: During a maximum of six 3-week chemotherapy cycles ]
- The frequency and severity of Serious Adverse Events [ Time Frame: During a maximum of six 3-week chemotherapy cycles ]
- The incidence and grade of toxicity experienced by each dose group, changes in biochemistry, hematology, urinalysis, physical findings, and adverse events [ Time Frame: During a maximum of six 3-week chemotherapy cycles ]
Information By: Tarix Pharmaceuticals
Dates:
Date Received: October 9, 2008
Date Started: October 2008
Date Completion:
Last Updated: October 11, 2016
Last Verified: October 2016
- Subjects With Platelet Counts Below 50,000/mm3 [ Time Frame: During a maximum of six 3-week chemotherapy cycles ]
