- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT00771810
Study of Drug to Reduce Thrombocytopenia in Patients Receiving Chemo for Ovarian, Fallopian Tube or Peritoneal Cancer
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
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Tényleges)
Fázis
- 2. fázis
Kapcsolatok és helyek
Tanulmányi helyek
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Alabama
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Mobile, Alabama, Egyesült Államok, 36604
- University of Southern Alabama Mitchell Cancer Institute
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California
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Los Angeles, California, Egyesült Államok, 90033
- USC - LAC Medical Center
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Orange, California, Egyesült Államok, 92868
- University of California - Irvine, Chao Family Comprehensive Cancer Center
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Illinois
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Chicago, Illinois, Egyesült Államok, 60612
- Rush University Medical Center
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Kansas
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Wichita, Kansas, Egyesült Államok, 67208
- Associates in Women's Health
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New York
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Brightwaters, New York, Egyesült Államok, 11718
- Schwartz Gynecologic Oncology, PLLC
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
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
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Támogató gondoskodás
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Négyszeres
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
---|---|
Placebo Comparator: Placebo
Combination gemcitabine and platinum-based chemotherapy with concurrent placebo
|
Once daily subcutaneous injection of placebo
|
Kísérleti: TXA127 100 ug/kg
Combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
|
Once daily subcutaneous injection of 100 ug/kg
Más nevek:
Once daily subcutaneous injection of 300 ug/kg
Más nevek:
|
Kísérleti: TXA127 300 ug/kg
Combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
|
Once daily subcutaneous injection of 100 ug/kg
Más nevek:
Once daily subcutaneous injection of 300 ug/kg
Más nevek:
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Chemotherapy Cycles During Which the Platelet Count Measures Below 50,000/mm3
Időkeret: During a maximum of six 3-week chemotherapy cycles
|
Mean percentage of cycles with platelet counts below 50,000/mm3
|
During a maximum of six 3-week chemotherapy cycles
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Subjects With Platelet Counts Below 50,000/mm3
Időkeret: During a maximum of six 3-week chemotherapy cycles
|
Number of subjects who experienced a platelet count below 50,000/mm3
|
During a maximum of six 3-week chemotherapy cycles
|
Treatment Cycles With Platelets Counts Below 25,000/mm3
Időkeret: During a maximum of six 3-week chemotherapy cycles
|
Mean percentage of treatment cycles where platelets counts were below 25,000/mm3
|
During a maximum of six 3-week chemotherapy cycles
|
Chemotherapy Dose Intensity and Dose Density
Időkeret: During a maximum of six 3-week chemotherapy cycles
|
Mean percentage of cycles where projected (target) chemotherapy dose was maintained
|
During a maximum of six 3-week chemotherapy cycles
|
Lymphopenia as Determined by Lymphocyte Count
Időkeret: During a maximum of six 3-week chemotherapy cycles
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Number of subjects with a treatment emergent adverse event of lymphopenia
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During a maximum of six 3-week chemotherapy cycles
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Neutropenia
Időkeret: During a maximum of six 3-week chemotherapy cycles
|
Number of subjects with a treatment emergent adverse event of neutropenia
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During a maximum of six 3-week chemotherapy cycles
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Anemia
Időkeret: During a maximum of six 3-week chemotherapy cycles
|
Number of subjects with a treatment emergent adverse event of anemia
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During a maximum of six 3-week chemotherapy cycles
|
Mucositis
Időkeret: During a maximum of six 3-week chemotherapy cycles
|
Number of subjects with a treatment emergent adverse event of mucositis
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During a maximum of six 3-week chemotherapy cycles
|
Alopecia
Időkeret: During a maximum of six 3-week chemotherapy cycles
|
Number of subjects with a treatment emergent adverse event of alopecia
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During a maximum of six 3-week chemotherapy cycles
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Rescue Treatment for Hematopoiesis and Mucositis
Időkeret: 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:
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During a maximum of six 3-week chemotherapy cycles
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Együttműködők és nyomozók
Szponzor
Publikációk és hasznos linkek
Általános kiadványok
- 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. doi: 10.1007/s00280-005-0078-4. Epub 2005 Aug 12.
- 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. doi: 10.1007/s00280-003-0710-0. Epub 2003 Oct 16.
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Becslés)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- TXA127-2007-002
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