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A Randomized, Double Blind, Multi-Center, Phase 2 Study to Estimate the Efficacy and Evaluate the Safety and Tolerability of Cisplatin & Capecitabine (CX) in Combination With AMG 386 or Placebo in Subjects With Metastatic Gastric, Gastroesophageal Junction, or Distal Esophageal Adenocarcinoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Gastrointestinal Cancer

Thank you

Trial Information

A Randomized, Double Blind, Multi-Center, Phase 2 Study to Estimate the Efficacy and Evaluate the Safety and Tolerability of Cisplatin & Capecitabine (CX) in Combination With AMG 386 or Placebo in Subjects With Metastatic Gastric, Gastroesophageal Junction, or Distal Esophageal Adenocarcinoma


Inclusion Criteria:



- 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

- Prior gastrectomy (total or partial) may be allowed as long as subjects can take
oral medications and meet all other inclusion/exclusion criteria. Subjects may
not take crushed or dissolved capecitabine via a feeding/gastrostomy tube

- 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

Exclusion Criteria:

- 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

- History of bleeding diathesis or clinically significant bleeding within 6 months
prior to randomization

- Major surgical procedure within 28 days prior to randomization

- Minor surgical procedure, placement of central venous access device or fine
needle aspiration within 3 days prior to randomization

- Prior malignancy except: malignancy treated with curative intent and without
evidence of active disease for ≥ 3 years prior to randomization and felt to be
at low risk for recurrence by treating physician, adequately treated
non-melanomatous skin cancer or lentigo maligna without evidence of disease,
adequately treated cervical carcinoma in situ without evidence of disease,
prostatic intraepithelial neoplasia without evidence of prostate cancer

- Prior malignancy (other than in situ cervical cancer, or basal cell cancer of
the skin) unless treated with curative intent and without evidence of disease
for ≥ 3 years prior to randomization

- Clinically significant cardiovascular diseases within 12 months prior to
randomization

- Presence of clinically significant non-healing wound, ulcer (including
gastrointestinal) or fracture as judged by the investigator

- Ongoing or clinically significant active infection as judged by the investigator

- Known hypersensitivity to bacterial proteins, or any of the drugs required in
this study

- Known peripheral neuropathy ≥Grade 1

- Known dihydropyrimidine dehydrogenase deficiency

- Known hypersensitivity to 5-FU/capecitabine

- Known positive test for human immunodeficiency virus (HIV), hepatitis C, or
hepatitis B surface antigen

- Known active or chronic hepatitis

- Medications

- Currently or previously treated with angiopoietin inhibitors, or inhibitors of
TIE-1 or TIE-2

- Treatment with immune modulators such as cyclosporine or tacrolimus within 30
days prior to randomization

- Treatment with sorivudine or its chemically related analogues

- Anticoagulants (other than aspirin and anti-platelet agents) within 7 days prior
to randomization. The concurrent use of low molecular weight heparin or
heparanoids or low dose warfarin (i.e, ≤ 1 mg daily) for prophylaxis against
thrombosis is acceptable while on study

- General

- Not yet completed at least 30 days since ending other investigational
device/drug trial(s), or subject is receiving other investigational treatments

- Pregnant or is breast feeding

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival (PFS)

Outcome Time Frame:

22 months

Safety Issue:

No

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

Australia: Therapeutic Goods Administration

Study ID:

20060439

NCT ID:

NCT00583674

Start Date:

December 2007

Completion Date:

June 2012

Related Keywords:

  • Gastrointestinal Cancer
  • Gastric Cancer
  • Metastatic Gastric, Gastroesophageal Junction, or Distal Esophageal Adenocarcinoma
  • AMG 386
  • Cisplatin
  • Capecitabine
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Esophageal Diseases
  • Gastrointestinal Neoplasms

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