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

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 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group 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:

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders Stomach Cancer

Drug Information available for: Cisplatin Epirubicin hydrochloride Epirubicin Capecitabine

U.S. FDA Resources

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
Estimated 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.
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

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

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

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

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:	April 15, 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
Adenocarcinoma, Mucinous
Esophageal Diseases
Esophageal Neoplasms
Stomach Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Cystic, Mucinous, and Serous
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site

Head and Neck Neoplasms
Stomach Diseases
Capecitabine
Cisplatin
Epirubicin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013