Anemia Clinical Trial
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
Verified date | October 2017 |
Source | Tarix Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Tarix Pharmaceuticals |
United States,
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
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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