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Sponsored by: |
Amgen |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00583674 |
This is a phase 2, randomized, double blind, placebo controlled, multi-center study to estimate the improvement in progression free survival (compared to control subjects) and evaluate the safety and tolerability of AMG 386 in combination with Cisplatin & Capecitabine in the treatment of subjects with Metastatic Gastric, Gastroesophageal Junction, or Distal Esophageal Adenocarcinoma. AMG 386 is a man-made medication that is designed to stop the development of blood vessels in cancer tissues. Cancer tissues rely on the development of new blood vessels, a process called angiogenesis, to obtain a supply of oxygen and nutrients to grow.
Condition | Intervention | Phase |
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Gastrointestinal Cancer |
Drug: AMG 386 placebo Drug: AMG 386 10mg/kg Drug: AMG 386 3mg/kg |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double Blind, Multi-Center, Phase 2 Study to Estimate the Efficacy and Evaluate the Safety and Tolerability of Cisplatin & Capecitabine (CX) in Combination With AMG 386 or Placebo in Subjects With Metastatic Gastric, Gastroesophageal Junction, or Distal Esophageal Adenocarcinoma |
Estimated Enrollment: | 165 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | March 2013 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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B: Experimental |
Drug: AMG 386 3mg/kg
Cisplatin 80 mg/m2 IV Q3W + capecitabine 1000 mg/m2 PO BID x 14 days Q3W + AMG 386 3 mg/kg IV QW until radiographic disease progression, clinical progression, unacceptable toxicity, subject withdrawal of consent, or death
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A: Experimental |
Drug: AMG 386 10mg/kg
Cisplatin 80 mg/m2 IV Q3W + capecitabine 1000 mg/m2 PO BID x 14 days Q3W + AMG 386 10 mg/kg IV QW until radiographic disease progression, clinical progression, unacceptable toxicity, subject withdrawal of consent, or death
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C: Active Comparator |
Drug: AMG 386 placebo
Cisplatin 80 mg/m2 IV Q3W + capecitabine1000 mg/m2 PO BID x 14 days Q3W + AMG 386 placebo IV QW until radiographic disease progression, clinical progression, unacceptable toxicity, subject withdrawal of consent, or death
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Disease Related
Demographic
•18 years of age or older at the time the written informed consent is obtained
General
Laboratory
Exclusion Criteria:
Disease Related
Medications
General
Contact: Amgen Call Center | 866-572-6436 |
Study Director: | MD | Amgen |
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20060439 |
Study First Received: | December 20, 2007 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00583674 |
Health Authority: | Australia: Therapeutic Goods Administration; Austria: AGES - PharmaMed Austria Institut Wissenschaft & Information; Austria: Bundesamt für Sicherheit im Gesundheitswesen; Belgium: Directorate-General for Medicinal Products; France: Afssaps - French Health Products Safety Agency; Hungary: National Institute of Pharmacy; Netherlands: CCMO (Centrale Commissie Mensgebonden Onderzoek): Central Committee Human Bound Research; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Spain: Agencia Española de Medicamentos y Productos Sanitarios; United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration; United States: Institutional Review Board |
Gastric Cancer Metastatic Gastric, Gastroesophageal Junction, or Distal Esophageal Adenocarcinoma AMG 386 Cisplatin Capecitabine |
Capecitabine Digestive System Neoplasms Esophageal disorder Gastrointestinal Diseases Stomach cancer Carcinoma Digestive System Diseases |
Cisplatin Stomach Neoplasms Gastrointestinal Neoplasms Esophageal Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |
Antimetabolites Neoplasms Antimetabolites, Antineoplastic Neoplasms by Site Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action |
Radiation-Sensitizing Agents Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs Pharmacologic Actions |