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Sponsored by: |
Amgen |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00479817 |
This study is a phase 2, randomized, double-blind, placebo controlled, multi-center study to estimate the improvement in PFS (compared to control subjects) and evaluate the safety and tolerability of AMG 386 in combination with paclitaxel in the treatment of subjects with advanced recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Primary Outcome Measure:
Secondary Outcome Measures:
Condition | Intervention | Phase |
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Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer |
Drug: AMG 386 Drug: Paclitaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo Controlled, Phase 2 Trial of Paclitaxel in Combination With AMG 386 in Subjects With Advanced Recurrent Epithelial Ovarian or Primary Peritoneal Cancer |
Estimated Enrollment: | 150 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | April 2013 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm A: Experimental |
Drug: AMG 386
10mg/kg (Arm A) or 3mg/kg (Arm B) delivered IV weekly.
Drug: Paclitaxel
Chemotherapy. 80mg/m2 delivered IV QW (3 on / 1 off).
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Arm B: Experimental |
Drug: AMG 386
10mg/kg (Arm A) or 3mg/kg (Arm B) delivered IV weekly.
Drug: Paclitaxel
Chemotherapy. 80mg/m2 delivered IV QW (3 on / 1 off).
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Arm C: Active Comparator |
Drug: Paclitaxel
Chemotherapy. 80mg/m2 delivered IV QW (3 on / 1 off).
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Absolute neutrophil count (ANC) ≥ 1.5 x 109/L Platelet count ≥ 100 x 109/L and ≤ 850 x 109/L Hemoglobin ≥ 9 g/dL PTT or aPTT≤ 1.5 x ULN per institutional laboratory rand and INR ≤ 1.5 x 109/L per instiutiona laboratory range
Renal function, as follows:
Creatinine ≤ 2.0 mg/dL Calculated creatinine clearance > 40 cc/min according to the Cockcroft-Gault formula
Total bilirubin ≤ 2.0 x ULN SGOT (AST) and SGPT (ALT) ≤ 2.5 x ULN (≤ 5 x ULN if liver metastases are present) Nutritional
Exclusion Criteria
Investigators should document the frequency of paracenteses and/or thoracentesis that occurred prior to the enrollment of the subject in this study on the appropriate eCRFs. Investigators should also document each paracentesis and/or thoracentesis that occurs while a subject is on study on the appropriate eCRFs.
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20060342 |
Study First Received: | May 24, 2007 |
Last Updated: | January 22, 2009 |
ClinicalTrials.gov Identifier: | NCT00479817 History of Changes |
Health Authority: | Australia: Therapeutic Goods Administration; Belgium: Federal Agency for Medicines and Health Products (FAMHP); Canada: Health Canada; India: Central Drugs Standard Control Organization; United States: Food and Drug Administration; United States: Western Institutional Review Board |
Advanced Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer |
Fallopian Tube Cancer Digestive System Neoplasms Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Antimitotic Agents Ovarian Diseases Abdominal Neoplasms Fallopian Tube Neoplasms Recurrence |
Fallopian Tube Diseases Genital Diseases, Female Digestive System Diseases Paclitaxel Tubulin Modulators Peritoneal Diseases Ovarian Cancer Gastrointestinal Neoplasms Endocrinopathy Peritoneal Neoplasms Antineoplastic Agents, Phytogenic Endocrine Gland Neoplasms |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gonadal Disorders Urogenital Neoplasms Ovarian Diseases Genital Diseases, Female Neoplasms by Site Therapeutic Uses Peritoneal Diseases Endocrine Gland Neoplasms Ovarian Neoplasms Digestive System Neoplasms Mitosis Modulators Genital Neoplasms, Female |
Endocrine System Diseases Antimitotic Agents Abdominal Neoplasms Fallopian Tube Neoplasms Pharmacologic Actions Adnexal Diseases Fallopian Tube Diseases Neoplasms Digestive System Diseases Paclitaxel Tubulin Modulators Peritoneal Neoplasms Antineoplastic Agents, Phytogenic |