AMG 102 Plus ECX for Unresectable Locally Advanced or Metastatic Gastric or Esophagogastric Junction Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00719550
First received: July 17, 2008
Last updated: November 13, 2013
Last verified: November 2013
  Purpose

Study Phase: 1b/2 Indication: Previously untreated subjects with unresectable locally advanced or metastatic gastric or esophagogastric junction adenocarcinoma.

Primary Objective(s):

Part 1: To identify safe dose levels of AMG 102, up to 15 mg/kg Q3W, to combine with ECX.

Part 2 (phase 2-double-blind): To estimate with pre-specified precision the effect of the addition of AMG 102 to ECX on progression free survival (PFS).


Condition Intervention Phase
Esophagogastric Junction Adenocarcinoma
Gastric Cancer
Esophageal Cancer
Drug: Capecitabine
Drug: Epirubicin
Drug: AMG 102
Drug: Cisplatin
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, 3-Arm, Phase 1b/2 Study in Subjects With Unresectable Locally Advanced or Metastatic Gastric or Esophagogastric Junction Adenocarcinoma to Evaluate the Safety and Efficacy of First-line Treatment With Epirubicin, Cisplatin, and Capecitabine(ECX) Plus AMG 102

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Progression free survival (PFS), as measured by RECIST per local review [ Time Frame: Subjects coming off study will be contacted by telephone or at routine clinic visits approximately every 3 months until 36 months from date the last subject is randomized into the study. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival, objective response rate, disease control rate, time to response (for responders only), and duration of response (for responders only). [ Time Frame: Subjects coming off study will be contacted by telephone or at routine clinic visits approximately every 3 months until 36 months from date the last subject is randomized into the study. ] [ Designated as safety issue: No ]
  • Incidence of adverse events, significant laboratory value changes form baseline and anti-AMG 102 antibody formation. [ Time Frame: Subjects coming off study will be contacted by telephone or at routine clinic visits approximately every 3 months until 36 months from date the last subject is randomized into the study. ] [ Designated as safety issue: Yes ]
  • Cmax and Cmin for AMG 102; Cmax and AUC for epirubicin and cisplatin with or without AMG 102 [ Time Frame: Subjects coming off study will be contacted by telephone or at routine clinic visits approximately every 3 months until 36 months from date the last subject is randomized into the study. ] [ Designated as safety issue: No ]

Enrollment: 130
Study Start Date: February 2009
Study Completion Date: June 2013
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Phase 2 Arm C
AMG 102 placebo plus ECX
Drug: Capecitabine
Administered at 625mg/m2 BID orally every day while on study.
Other Name: Xeloda
Drug: Epirubicin
Administered day 1 of each cycle at 50mg/m2 IV.
Drug: Cisplatin
Administered day 1 of each cycle at 60mg/m2 IV.
Drug: Placebo
AMG 102 placebo will be provided in similar vials as clear, colorless, sterile protein-free solution
Phase 1b
Phase 1b dose study with open-labe AMG 102 at 15mg/kg de-escalating to 7.5mg/kg and 5mg/kg if needed.
Drug: Capecitabine
Administered at 625mg/m2 BID orally every day while on study.
Other Name: Xeloda
Drug: Epirubicin
Administered day 1 of each cycle at 50mg/m2 IV.
Drug: AMG 102
Investigation product to be given at 15mg/kg, 7.5mg/kg, or 5mg/kg depending on assignment.
Drug: Cisplatin
Administered day 1 of each cycle at 60mg/m2 IV.
Active Comparator: Phase 2 Arm B
AMG 102 at 7.5mg/kg plus ECX
Drug: Capecitabine
Administered at 625mg/m2 BID orally every day while on study.
Other Name: Xeloda
Drug: Epirubicin
Administered day 1 of each cycle at 50mg/m2 IV.
Drug: AMG 102
Investigation product to be given at 15mg/kg, 7.5mg/kg, or 5mg/kg depending on assignment.
Drug: Cisplatin
Administered day 1 of each cycle at 60mg/m2 IV.
Active Comparator: Phase 2 Arm A
AMG 102 at 15mg/kg plus ECX
Drug: Capecitabine
Administered at 625mg/m2 BID orally every day while on study.
Other Name: Xeloda
Drug: Epirubicin
Administered day 1 of each cycle at 50mg/m2 IV.
Drug: AMG 102
Investigation product to be given at 15mg/kg, 7.5mg/kg, or 5mg/kg depending on assignment.
Drug: Cisplatin
Administered day 1 of each cycle at 60mg/m2 IV.

  Eligibility

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

Inclusion Criteria:

  • Pathologically confirmed unresectable locally advanced or metastatic gastric or esophagogastric junction (EGJ) adenocarcinoma; tumors of the distal esophagus within 5 cm of the EGJ are eligible
  • ECOG performance status 0 or 1
  • Male or female ≥ 18 years of age

Exclusion Criteria:

  • Previous systemic therapy (chemotherapy or biologic therapy) for locally advanced or metastatic gastric or esophagogastric adenocarcinoma
  • Less than 6 months have elapsed from completion of prior neoadjuvant or adjuvant chemotherapy or chemoradiotherapy.
  • Subjects with resectable disease or suitable for definitive chemoradiation
  • Subjects with persistent gastric outlet obstruction, complete dysphagia or feeding jejunostomy
  • Tumors of squamous cell histology
  • Known central nervous system metastases
  • Clinically significant upper gastro-intestinal bleeding ≤ 30 days prior to enrollment or randomization
  • Serious or non-healing wound
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00719550

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00719550     History of Changes
Other Study ID Numbers: 20060317
Study First Received: July 17, 2008
Last Updated: November 13, 2013
Health Authority: Canada: Health Canada
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
United States: Western Institutional Review Board
Poland: Ministry of Health
Spain: Ministry of Health
Italy: Ministry of Health
Greece: Ministry of Health and Welfare
Russia: Ministry of Health of the Russian Federation
India: Ministry of Health
Hong Kong: Department of Health
Singapore: Health Sciences Authority
Australia: National Health and Medical Research Council
Belgium: Federal Agency for Medicinal Products and Health Products
Hungary: National Institute of Pharmacy

Keywords provided by Amgen:
Locally Advanced
Metastatic

Additional relevant MeSH terms:
Adenocarcinoma
Esophageal Neoplasms
Stomach Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Stomach Diseases
Capecitabine
Cisplatin
Epirubicin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on August 28, 2014