- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
-
-
Alabama
-
Mobile, Alabama, États-Unis, 36604
- University of Southern Alabama Mitchell Cancer Institute
-
-
California
-
Los Angeles, California, États-Unis, 90033
- USC - LAC Medical Center
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Orange, California, États-Unis, 92868
- University of California - Irvine, Chao Family Comprehensive Cancer Center
-
-
Illinois
-
Chicago, Illinois, États-Unis, 60612
- Rush University Medical Center
-
-
Kansas
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Wichita, Kansas, États-Unis, 67208
- Associates in Women's Health
-
-
New York
-
Brightwaters, New York, États-Unis, 11718
- Schwartz Gynecologic Oncology, PLLC
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur placebo: Placebo
Combination gemcitabine and platinum-based chemotherapy with concurrent placebo
|
Once daily subcutaneous injection of placebo
|
Expérimental: 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
Autres noms:
Once daily subcutaneous injection of 300 ug/kg
Autres noms:
|
Expérimental: 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
Autres noms:
Once daily subcutaneous injection of 300 ug/kg
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Chemotherapy Cycles During Which the Platelet Count Measures Below 50,000/mm3
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Subjects With Platelet Counts Below 50,000/mm3
Délai: 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
Délai: 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
Délai: 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
Délai: During a maximum of six 3-week chemotherapy cycles
|
Number of subjects with a treatment emergent adverse event of lymphopenia
|
During a maximum of six 3-week chemotherapy cycles
|
Neutropenia
Délai: During a maximum of six 3-week chemotherapy cycles
|
Number of subjects with a treatment emergent adverse event of neutropenia
|
During a maximum of six 3-week chemotherapy cycles
|
Anemia
Délai: During a maximum of six 3-week chemotherapy cycles
|
Number of subjects with a treatment emergent adverse event of anemia
|
During a maximum of six 3-week chemotherapy cycles
|
Mucositis
Délai: During a maximum of six 3-week chemotherapy cycles
|
Number of subjects with a treatment emergent adverse event of mucositis
|
During a maximum of six 3-week chemotherapy cycles
|
Alopecia
Délai: During a maximum of six 3-week chemotherapy cycles
|
Number of subjects with a treatment emergent adverse event of alopecia
|
During a maximum of six 3-week chemotherapy cycles
|
Rescue Treatment for Hematopoiesis and Mucositis
Délai: 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:
|
During a maximum of six 3-week chemotherapy cycles
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- TXA127-2007-002
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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