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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00771810
Recruitment Status : Completed
First Posted : October 13, 2008
Results First Posted : June 7, 2013
Last Update Posted : November 13, 2017
Sponsor:
Information provided by (Responsible Party):
Tarix Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE October 9, 2008
First Posted Date  ICMJE October 13, 2008
Results First Submitted Date  ICMJE February 25, 2013
Results First Posted Date  ICMJE June 7, 2013
Last Update Posted Date November 13, 2017
Study Start Date  ICMJE October 2008
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2013)
Chemotherapy Cycles During Which the Platelet Count Measures Below 50,000/mm3 [ Time Frame: During a maximum of six 3-week chemotherapy cycles ]
Mean percentage of cycles with platelet counts below 50,000/mm3
Original Primary Outcome Measures  ICMJE
 (submitted: October 9, 2008)
The severity and incidence of thrombocytopenia as determined by the number of patient chemotherapy cycles during which the platelet count measures below 50,000/mm3 (NCI Grade 3 and/or 4 thrombocytopenia). [ Time Frame: During a maximum of six 3-week chemotherapy cycles ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2013)
  • Subjects With Platelet Counts Below 50,000/mm3 [ Time Frame: During a maximum of six 3-week chemotherapy cycles ]
    Number of subjects who experienced a platelet count below 50,000/mm3
  • Treatment Cycles With Platelets Counts Below 25,000/mm3 [ Time Frame: During a maximum of six 3-week chemotherapy cycles ]
    Mean percentage of treatment cycles where platelets counts were below 25,000/mm3
  • Chemotherapy Dose Intensity and Dose Density [ Time Frame: During a maximum of six 3-week chemotherapy cycles ]
    Mean percentage of cycles where projected (target) chemotherapy dose was maintained
  • Lymphopenia as Determined by Lymphocyte Count [ Time Frame: During a maximum of six 3-week chemotherapy cycles ]
    Number of subjects with a treatment emergent adverse event of lymphopenia
  • Neutropenia [ Time Frame: During a maximum of six 3-week chemotherapy cycles ]
    Number of subjects with a treatment emergent adverse event of neutropenia
  • Anemia [ Time Frame: During a maximum of six 3-week chemotherapy cycles ]
    Number of subjects with a treatment emergent adverse event of anemia
  • Mucositis [ Time Frame: During a maximum of six 3-week chemotherapy cycles ]
    Number of subjects with a treatment emergent adverse event of mucositis
  • Alopecia [ Time Frame: During a maximum of six 3-week chemotherapy cycles ]
    Number of subjects with a treatment emergent adverse event of alopecia
  • Rescue Treatment for Hematopoiesis and Mucositis [ Time Frame: During a maximum of six 3-week chemotherapy cycles ]
    Number of subjects with a treatment emergent adverse event of hematopoiesis and mucositis who received rescue treatment as determined by the administration of:
    1. Transfusions
    2. Filgrastim or Pegfilgrastim
    3. Erythropoietin
    4. Palifermin
Original Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2008)
  • The severity and incidence of thrombocytopenia as determined by the number of patients who experience a platelet count below 50,000/mm3 (NCI Grade 3 and/or 4 thrombocytopenia). [ Time Frame: During a maximum of six 3-week chemotherapy cycles ]
  • The severity and incidence of thrombocytopenia as determined by absolute nadir and time to recovery of platelet count for each treatment cycle and study subject. [ Time Frame: During a maximum of six 3-week chemotherapy cycles ]
  • The frequency and severity of Serious Adverse Events [ Time Frame: During a maximum of six 3-week chemotherapy cycles ]
  • The incidence and grade of toxicity experienced by each dose group, changes in biochemistry, hematology, urinalysis, physical findings, and adverse events [ Time Frame: During a maximum of six 3-week chemotherapy cycles ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Drug to Reduce Thrombocytopenia in Patients Receiving Chemo for Ovarian, Fallopian Tube or Peritoneal Cancer
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Thrombocytopenia
  • Neutropenia
  • Lymphopenia
  • Anemia
Intervention  ICMJE
  • Drug: TXA127
    Once daily subcutaneous injection of 100 ug/kg
    Other Name: Angiotensin 1-7
  • Drug: TXA127
    Once daily subcutaneous injection of 300 ug/kg
    Other Name: Angiotensin 1-7
  • Drug: Placebo
    Once daily subcutaneous injection of placebo
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Combination gemcitabine and platinum-based chemotherapy with concurrent placebo
    Intervention: Drug: Placebo
  • Experimental: TXA127 100 ug/kg
    Combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
    Intervention: Drug: TXA127
  • Experimental: TXA127 300 ug/kg
    Combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
    Intervention: Drug: TXA127
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 21, 2011)
34
Original Estimated Enrollment  ICMJE
 (submitted: October 9, 2008)
75
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00771810
Other Study ID Numbers  ICMJE TXA127-2007-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tarix Pharmaceuticals
Study Sponsor  ICMJE Tarix Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gere S diZerega, MD US Biotest, Inc.
PRS Account Tarix Pharmaceuticals
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP