Study of Drug to Reduce Thrombocytopenia in Patients Receiving Chemo for Ovarian, Fallopian Tube or Peritoneal Cancer

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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