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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


Phase 2
18 Years
N/A
Not Enrolling
Female
Thrombocytopenia, Neutropenia, Lymphopenia, Anemia

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Trial Information

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 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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

Chemotherapy Cycles During Which the Platelet Count Measures Below 50,000/mm3

Outcome Description:

Mean percentage of cycles with platelet counts below 50,000/mm3

Outcome Time Frame:

During a maximum of six 3-week chemotherapy cycles

Safety Issue:

No

Principal Investigator

Gere S diZerega, MD

Investigator Role:

Study Director

Investigator Affiliation:

US Biotest, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

TXA127-2007-002

NCT ID:

NCT00771810

Start Date:

October 2008

Completion Date:

December 2011

Related Keywords:

  • Thrombocytopenia
  • Neutropenia
  • Lymphopenia
  • Anemia
  • Ovarian Cancer
  • Thrombocytopenia
  • Cytopenia
  • Chemotherapy
  • Anemia
  • Lymphopenia
  • Neutropenia
  • Thrombocytopenia

Name

Location

Rush University Medical CenterChicago, Illinois  60612-3824
Associates in Women's HealthWichita, Kansas  67214
Schwartz Gynecologic Oncology, PLLCBabylon, New York  11702
University of Southern Alabama Mitchell Cancer InstituteMobile, Alabama  36604
USC - LAC Medical CenterLos Angeles, California  90033
University of California - Irvine, Chao Family Comprehensive Cancer CenterOrange, California  92868