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Sponsors and Collaborators: |
US Biotest, Inc. Tarix Pharmaceuticals, Inc. |
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Information provided by: | US Biotest, Inc. |
ClinicalTrials.gov Identifier: | NCT00771810 |
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 recurrent 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.
Condition | Intervention | Phase |
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Thrombocytopenia Neutropenia Lymphopenia Anemia |
Drug: Angiotensin 1-7 |
Phase II |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase IIb Study Evaluating the Safety and Efficacy of TXA127 in the Reduction of Incidence and Severity of Thrombocytopenia in Patients Receiving Second-Line Combination Gemcitabine and Platinum Therapy for Recurrent Ovarian Carcinoma |
Estimated Enrollment: | 75 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator
Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
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Drug: Angiotensin 1-7
Once daily subcutaneous injection of 10 microliters/kilogram/day of 10 mg/mL, 30 mg/mL or placebo solution
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2: Experimental
Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
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Drug: Angiotensin 1-7
Once daily subcutaneous injection of 10 microliters/kilogram/day of 10 mg/mL, 30 mg/mL or placebo solution
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3: Experimental
Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
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Drug: Angiotensin 1-7
Once daily subcutaneous injection of 10 microliters/kilogram/day of 10 mg/mL, 30 mg/mL or placebo solution
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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.
Patients diagnosed with recurrent ovarian cancer after a progression-free interval of at least 3 months following cytoreduction surgery and a single course of chemotherapy who are scheduled to undergo second-line, combination chemotherapy with gemcitabine and carboplatin or gemcitabine and cisplatin will be considered for this study.
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
Regimen B
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Rebecca Weegar | 805-595-1300 | Rebecca.Weegar@USBiotest.com |
United States, California | |
University of California - Irvine, Chao Family Comprehensive Cancer Center | Recruiting |
Orange, California, United States, 92868 | |
Contact: Clinical Research 877-827-8839 UCStudy@uci.edu | |
Principal Investigator: Krishnansu Tewari, MD | |
Sub-Investigator: Philip DiSaia, MD | |
Sub-Investigator: Bradley Monk, MD | |
Sub-Investigator: Leslie Randall, MD |
Study Director: | Gere S diZerega, MD | US Biotest, Inc. |
Responsible Party: | US Biotest, Inc. ( Gere S. diZerega, MD, President and CEO ) |
Study ID Numbers: | TXA127-2007-002 |
Study First Received: | October 9, 2008 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00771810 |
Health Authority: | United States: Food and Drug Administration |
Ovarian Cancer Thrombocytopenia Cytopenia Chemotherapy |
Gonadal Disorders Leukocyte Disorders Urogenital Neoplasms Ovarian Diseases Ovarian epithelial cancer Granulocytopenia Genital Diseases, Female Thrombocytopenia Gemcitabine Endocrine Gland Neoplasms Ovarian cancer Ovarian Neoplasms Hematologic Diseases Blood Platelet Disorders |
Agranulocytosis Lymphopenia Anemia Genital Neoplasms, Female Endocrine System Diseases Angiotensin I (1-7) Immunologic Deficiency Syndromes Recurrence Carcinoma Neutropenia Thrombocytopathy Endocrinopathy Leukopenia |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Immune System Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Cardiovascular Agents |
Antihypertensive Agents Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Adnexal Diseases Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses |