Phase 2 Study of AMG 386 (20060439) in Combination With Cisplatin & Capecitabine in Subjects With Metastatic Gastric, Gastroesophageal Junction, or Distal Esophageal Adenocarcinoma

NCT00583674 | Completed Phase 2

• 1 other identifier: 20060439
• Study Type: interventional
• Target: 171
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Gastrointestinal Cancer

Keywords

Gastric Cancer; Metastatic Gastric, Gastroesophageal Junction, or Distal Esophageal Adenocarcinoma; AMG 386; Cisplatin; Capecitabine

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  22 months

Secondary Outcomes (8)

• Safety and Tolerability

  22 months

• Objective Response Rate (ORR)

  22 months

• Duration of Response (DOR)

  22 months

• Overall Survival (OS)

  22 months

• Time to Progression (TTP)

  22 months

Study Arms (3)

B

EXPERIMENTAL

Drug: AMG 386 3mg/kg; Drug: Cisplatin; Drug: Capecitabine

A

EXPERIMENTAL

Drug: AMG 386 10mg/kg; Drug: Cisplatin; Drug: Capecitabine

C

ACTIVE COMPARATOR

Drug: AMG 386 placebo; Drug: Cisplatin; Drug: Capecitabine

Interventions

AMG 386 placebo DRUG

AMG 386 placebo IV QW until radiographic disease progression, clinical progression, unacceptable toxicity, subject withdrawal of consent, or death

C

AMG 386 10mg/kg DRUG

AMG 386 10 mg/kg IV QW until radiographic disease progression, clinical progression, unacceptable toxicity, subject withdrawal of consent, or death

A

AMG 386 3mg/kg DRUG

AMG 386 3 mg/kg IV QW until radiographic disease progression, clinical progression, unacceptable toxicity, subject withdrawal of consent, or death

B

Cisplatin DRUG

Cisplatin 80 mg/m2 IV Q3W until radiographic disease progression, clinical progression, unacceptable toxicity, subject withdrawal of consent, or death

C

Capecitabine DRUG

Capecitabine1000 mg/m2 PO BID x 14 days Q3W until radiographic disease progression, clinical progression, unacceptable toxicity, subject withdrawal of consent, or death

C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Palliative radiotherapy for metastatic esophageal or gastric cancer prior to study entry may be allowed as long as all toxicities from radiotherapy have resolved and the radiotherapy was not to the only site of known metastatic disease
• 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
• 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
• Radiotherapy ≤ 14 days prior to randomization. Subjects must have recovered from all radiotherapy-related toxicities
• Current or prior history of central nervous system metastases
• History of arterial or deep venous thromboembolism within 12 months prior to randomization

Sponsors & Collaborators

• Amgen: lead

Related Publications (1)

• Eatock MM, Tebbutt NC, Bampton CL, Strickland AH, Valladares-Ayerbes M, Swieboda-Sadlej A, Van Cutsem E, Nanayakkara N, Sun YN, Zhong ZD, Bass MB, Adewoye AH, Bodoky G. Phase II randomized, double-blind, placebo-controlled study of AMG 386 (trebananib) in combination with cisplatin and capecitabine in patients with metastatic gastro-oesophageal cancer. Ann Oncol. 2013 Mar;24(3):710-8. doi: 10.1093/annonc/mds502. Epub 2012 Oct 28.

  PMID: 23108953 BACKGROUND

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Stomach Neoplasms

Interventions

trebananib; Cisplatin; Capecitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: December 31, 2007
• Study Start: December 1, 2007
• Primary Completion: March 1, 2010
• Study Completion: June 1, 2012
• Last Updated: May 7, 2014

Record last verified: 2014-04