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

November 13, 2013 updated by: Amgen

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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
Other: 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 Names:
  • 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: AMG 102
Investigation product to be given at 15mg/kg, 7.5mg/kg, or 5mg/kg depending on assignment.
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 Names:
  • 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: AMG 102
Investigation product to be given at 15mg/kg, 7.5mg/kg, or 5mg/kg depending on assignment.
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 Names:
  • 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: AMG 102
Investigation product to be given at 15mg/kg, 7.5mg/kg, or 5mg/kg depending on assignment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
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.

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
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.
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.
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.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

July 17, 2008

First Submitted That Met QC Criteria

July 18, 2008

First Posted (Estimate)

July 21, 2008

Study Record Updates

Last Update Posted (Estimate)

December 5, 2013

Last Update Submitted That Met QC Criteria

November 13, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20060317

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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