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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00771810
Other study ID # TXA127-2007-002
Secondary ID
Status Completed
Phase Phase 2
First received October 9, 2008
Last updated October 10, 2017
Start date October 2008
Est. completion date December 2011

Study information

Verified date October 2017
Source Tarix Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
TXA127
Once daily subcutaneous injection of 100 ug/kg
TXA127
Once daily subcutaneous injection of 300 ug/kg
Placebo
Once daily subcutaneous injection of placebo

Locations

Country Name City State
United States Schwartz Gynecologic Oncology, PLLC Brightwaters New York
United States Rush University Medical Center Chicago Illinois
United States USC - LAC Medical Center Los Angeles California
United States University of Southern Alabama Mitchell Cancer Institute Mobile Alabama
United States University of California - Irvine, Chao Family Comprehensive Cancer Center Orange California
United States Associates in Women's Health Wichita Kansas

Sponsors (1)

Lead Sponsor Collaborator
Tarix Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (2)

Ellefson DD, diZerega GS, Espinoza T, Roda N, Maldonado S, Rodgers KE. Synergistic effects of co-administration of angiotensin 1-7 and Neupogen on hematopoietic recovery in mice. Cancer Chemother Pharmacol. 2004 Jan;53(1):15-24. Epub 2003 Oct 16. — View Citation

Rodgers KE, Oliver J, diZerega GS. Phase I/II dose escalation study of angiotensin 1-7 [A(1-7)] administered before and after chemotherapy in patients with newly diagnosed breast cancer. Cancer Chemother Pharmacol. 2006 May;57(5):559-68. Epub 2005 Aug 12. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Chemotherapy Cycles During Which the Platelet Count Measures Below 50,000/mm3 Mean percentage of cycles with platelet counts below 50,000/mm3 During a maximum of six 3-week chemotherapy cycles
Secondary Subjects With Platelet Counts Below 50,000/mm3 Number of subjects who experienced a platelet count below 50,000/mm3 During a maximum of six 3-week chemotherapy cycles
Secondary Treatment Cycles With Platelets Counts Below 25,000/mm3 Mean percentage of treatment cycles where platelets counts were below 25,000/mm3 During a maximum of six 3-week chemotherapy cycles
Secondary Chemotherapy Dose Intensity and Dose Density Mean percentage of cycles where projected (target) chemotherapy dose was maintained During a maximum of six 3-week chemotherapy cycles
Secondary Lymphopenia as Determined by Lymphocyte Count Number of subjects with a treatment emergent adverse event of lymphopenia During a maximum of six 3-week chemotherapy cycles
Secondary Neutropenia Number of subjects with a treatment emergent adverse event of neutropenia During a maximum of six 3-week chemotherapy cycles
Secondary Anemia Number of subjects with a treatment emergent adverse event of anemia During a maximum of six 3-week chemotherapy cycles
Secondary Mucositis Number of subjects with a treatment emergent adverse event of mucositis During a maximum of six 3-week chemotherapy cycles
Secondary Alopecia Number of subjects with a treatment emergent adverse event of alopecia During a maximum of six 3-week chemotherapy cycles
Secondary Rescue Treatment for Hematopoiesis and Mucositis Number of subjects with a treatment emergent adverse event of hematopoiesis and mucositis who received rescue treatment as determined by the administration of:
Transfusions
Filgrastim or Pegfilgrastim
Erythropoietin
Palifermin
During a maximum of six 3-week chemotherapy cycles
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