A Ranomized, Double Blinded, 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
- Conditions
- Maag- en slokdarmkankerdistal esophageal carcinomagastroesophageal junctionmetastatic gastric
- Registration Number
- NL-OMON32061
- Lead Sponsor
- Amgen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 9
- Histologically or cytologically confirmed adenocarcinoma of the stomach, gastroesophageal junction or distal esophagus with metastatic disease.
- 18 years of age or older at the time the written informed consent is obtained
- Subjects of child-bearing potential and sexually active must use an accepted and
effective non-hormonal method of contraception (ie, double barrier method [eg, condom plus diaphragm]) from signing the informed consent through 6 months following last administration of study drug
- Able to tolerate intravenous infusions
- Able to swallow oral medication
- ECOG of 0 or 1 (within 14 days prior to randomization)
- Adequate organ and hematological function as evidenced by laboratory studies
within 14 days prior to randomization.
For a complete list of all inclusion criteria please see protocol page 41 and 42.
- Prior chemotherapy for metastatic disease (1st line)
- Less than 12 months have elapsed from completion of previous adjuvant or neoadjuvant chemotherapy or chemoradiotherapy
- Patients with persistant gastric outlet obstruction, complete dysphagia or feeding jejunostomy.
For a complete list of all exclusion criteria please see protocol page 42 and 43.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Progression-free survival (PFS).</p><br>
- Secondary Outcome Measures
Name Time Method