Brief Title
Study of Drug to Reduce Thrombocytopenia in Patients Receiving Chemo for Ovarian, Fallopian Tube or Peritoneal Cancer
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 Ovarian, Fallopian Tube, or Peritoneal Carcinoma
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 Description
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Chemotherapy Cycles During Which the Platelet Count Measures Below 50,000/mm3
Secondary Outcome
Subjects With Platelet Counts Below 50,000/mm3
Condition
Thrombocytopenia
Intervention
TXA127
Study Arms / Comparison Groups
Placebo
Description: Combination gemcitabine and platinum-based chemotherapy with concurrent placebo
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
34
Start Date
October 2008
Completion Date
December 2011
Primary Completion Date
December 2011
Eligibility Criteria
Inclusion Criteria:
- Females at least 18 years of age with ovarian carcinoma who are one of the following:
- Newly diagnosed with ovarian cancer and chemotherapy naïve, or
- Post a single previous course of chemotherapy, with a 3-month disease-progression
and treatment-free interval, with the exception of antibody therapy, prior to the
study screening visit, or
- Post two or more previous courses of chemotherapy with a 6-month
disease-progression and treatment-free interval, with the exception of antibody
therapy, prior to the study screening visit.
- Must be scheduled for a course of combination chemotherapy consisting of gemcitabine
and cisplatin or gemcitabine and carboplatin to be administered in 21-day cycles
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
- Adequate bone marrow, renal, and hepatic functions as measured by standard chemistry
and hematology blood tests
- Adequate blood coagulation parameters as measured by standard blood tests for
coagulation
Exclusion Criteria:
- Any clinical or laboratory abnormality greater than Grade 2 toxicity (NCI criteria),
with the exception of laboratory parameters specified in the inclusion criteria
- Significant unstable cardiovascular disease
- Uncontrolled high blood pressure
- Current use of an angiotensin converting enzyme (ACE) inhibitor or angiotensin II
antagonists
- Evidence of metastatic disease to the bone
- Metastatic disease to the CNS requiring treatment or radiation therapy
- Uncontrolled infection(s)
- Radiation therapy or chemotherapy (except as specified in the inclusion criteria)
within the previous 5 years
- Concurrent use of hematopoietic or erythropoietic agents
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Gere S diZerega, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00771810
Organization ID
TXA127-2007-002
Responsible Party
Sponsor
Study Sponsor
Tarix Pharmaceuticals
Study Sponsor
Gere S diZerega, MD, Study Director, US Biotest, Inc.
Verification Date
October 2017