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Phase 2 Study of AMG 386 (20060439) in Combination With Cisplatin & Capecitabine in Subjects With Metastatic Gastric, Gastroesophageal Junction, or Distal Esophageal Adenocarcinoma
This study is currently recruiting participants.
Verified by Amgen, January 2009
Sponsored by: Amgen
Information provided by: Amgen
ClinicalTrials.gov Identifier: NCT00583674
  Purpose

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
Gastrointestinal Cancer
Drug: AMG 386 placebo
Drug: AMG 386 10mg/kg
Drug: AMG 386 3mg/kg
Phase II

MedlinePlus related topics: Cancer Esophagus Disorders
Drug Information available for: Cisplatin Capecitabine AMG 386
U.S. FDA Resources
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

Further study details as provided by Amgen:

Primary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: 20 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and Tolerability [ Time Frame: 20 months ] [ Designated as safety issue: Yes ]
  • Objective Response Rate (ORR) [ Time Frame: 20 months ] [ Designated as safety issue: No ]
  • Duration of Response (DOR) [ Time Frame: 20 months ] [ Designated as safety issue: No ]
  • Overall Survival (OS) [ Time Frame: 20 months ] [ Designated as safety issue: No ]
  • Time to Progression (TTP) [ Time Frame: 20 months ] [ Designated as safety issue: No ]
  • Time to Response [ Time Frame: 20 months ] [ Designated as safety issue: No ]
  • Pharmacokinetics [ Time Frame: 20 months ] [ Designated as safety issue: No ]
  • Patient Reported Outcomes [ Time Frame: 20 months ] [ Designated as safety issue: No ]

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
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
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
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Disease Related

    • Histologically or cytologically confirmed adenocarcinoma of the stomach, gastroesophageal junction or distal esophagus with metastatic disease
    • Measurable or non-measurable disease per RECIST Guidelines
  • Demographic

    •18 years of age or older at the time the written informed consent is obtained

  • General

    • Able to swallow oral medication
    • ECOG performance status of 0 or 1
  • Laboratory

    • Adequate organ and hematological function as evidenced by laboratory studies prior to randomization

Exclusion Criteria:

  • Disease Related

    • Prior chemotherapy for metastatic disease (1st line)
    • Less than 12 months have elapsed from completion of previous adjuvant or neoadjuvant chemotherapy or chemoradiotherapy
    • Subjects with persistent gastric outlet obstruction, complete dysphagia or feeding jejunostomy
    • Current or prior history of central nervous system metastases
    • History of bleeding diathesis or clinically significant bleeding within 14 days prior to randomization
    • Major surgical procedure within 28 days prior to randomization
    • Minor surgical procedure, placement of access device or fine needle aspiration within 7 days prior to first dose
    • Prior malignancy (other than in situ cervical cancer, or basal cell cancer of the skin) unless treated with curative intent and without evidence of disease for ≥ 3 years prior to randomization
    • Clinically significant cardiovascular diseases within 12 months prior to randomization
    • Presence of clinically significant non-healing wound, ulcer or fracture as judged by the investigator
    • Ongoing or clinically significant active infection as judged by the investigator
    • Known hypersensitivity to bacterial proteins, or any of the drugs required in this study
    • Known peripheral neuropathy ≥Grade 1
    • Known dihydropyrimidine dehydrogenase deficiency
    • Known hypersensitivity to 5-FU/capecitabine
    • Known positive test for human immunodeficiency virus (HIV), hepatitis C, or hepatitis B surface antigen
    • Known active or chronic hepatitis
  • Medications

    • Currently or previously treated with angiopoietin inhibitors, or inhibitors of TIE-1 or TIE-2
    • Treatment with immune modulators such as cyclosporine or tacrolimus within 30 days prior to randomization
    • Treatment with sorivudine or its chemically related analogues
    • Anticoagulants (other than aspirin) including coumarin-type anticoagulants within 7 days prior to randomization
  • General

    • Not yet completed at least 30 days since ending other investigational device/drug trial(s), or subject is receiving other investigational treatments
    • Pregnant or is breast feeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00583674

Contacts
Contact: Amgen Call Center 866-572-6436

  Show 38 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site

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

Keywords provided by Amgen:
Gastric Cancer
Metastatic Gastric, Gastroesophageal Junction, or Distal Esophageal Adenocarcinoma
AMG 386
Cisplatin
Capecitabine

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 16, 2009