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



Status:Archived
Conditions:Lymphoma, Anemia, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:October 2008
End Date:December 2010

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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 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.


We found this trial at
6
sites
1983 Marengo St
Los Angeles, California 90033
(323) 226-2622
Los Angeles County-USC Medical Center The origins of LAC+USC Medical Center date back to 1878,...
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Brightwaters, New York 11718
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Chicago, IL
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Mobile, AL
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Orange, California 92868
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Orange, CA
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3232 E Murdock St
Wichita, Kansas 67208
(316) 685-7234
Associates in Women's Health Serving the Wichita region, the physicans and staff at Associates in...
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Wichita, KS
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