AMG 102 Plus ECX for Unresectable Locally Advanced or Metastatic Gastric or Esophagogastric Junction Cancer - Full Text View

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00719550

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	Phase I Phase II

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders Stomach Cancer

Drug Information available for: Cisplatin Capecitabine Epirubicin hydrochloride Epirubicin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Single Group Assignment, Safety/Efficacy Study
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

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:

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 ]
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 ]
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 ]

Estimated Enrollment:	136
Study Start Date:	August 2008
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Phase 2 Arm C: Placebo Comparator AMG 102 placebo plus ECX	Drug: Capecitabine Administered at 625mg/m2 BID orally every day while on study. Drug: Epirubicin Administered day 1 of each cycle at 50mg/m2 IV. Drug: Cisplatin Administered day 1 of each cycle at 60mg/m2 IV.
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. 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.
Phase 2 Arm B: Active Comparator AMG 102 at 7.5mg/kg plus ECX	Drug: Capecitabine Administered at 625mg/m2 BID orally every day while on study. 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.
Phase 2 Arm A: Active Comparator AMG 102 at 15mg/kg plus ECX	Drug: Capecitabine Administered at 625mg/m2 BID orally every day while on study. 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

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

Contacts

Contact: Amgen Call Center

866-572-6436

Locations

United States, Arizona
Research Site	Recruiting
Tucson, Arizona, United States
United States, Connecticut
Research Site	Recruiting
Stamford, Connecticut, United States
United States, Maryland
Research Site	Recruiting
Baltimore, Maryland, United States
United States, North Carolina
Research Site	Recruiting
Charlotte, North Carolina, United States
United Kingdom
Research Site	Recruiting
Leicester, United Kingdom
Research Site	Recruiting
Manchester, United Kingdom

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:	20060317
Study First Received:	July 17, 2008
Last Updated:	December 18, 2008
ClinicalTrials.gov Identifier:	NCT00719550
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration; United States: Western Institutional Review Board; Canada: Health Canada

Keywords provided by Amgen:

Locally Advanced
Metastatic

Study placed in the following topic categories:

Capecitabine
Digestive System Neoplasms
Esophageal disorder
Gastrointestinal Diseases
Esophageal Neoplasms
Stomach cancer
Epirubicin
Carcinoma
Digestive System Diseases

Stomach Diseases
Cisplatin
Stomach Neoplasms
Head and Neck Neoplasms
Gastrointestinal Neoplasms
Esophageal Diseases
Adenocarcinoma
Esophageal neoplasm
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
Antibiotics, Antineoplastic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009