Phase 1b/2 clinical trial in patients with cancer to Evaluate the Safety and Efficacy of First-line Treatment With Epirubicin, Cisplatin, and Capecitabine(ECX) Plus drug AMG 102.
- Conditions
- Health Condition 1: null- Esophagogastric Junction AdenocarcinomaGastric CancerEsophageal CancerHealth Condition 2: C169- Malignant neoplasm of stomach, unspecified
- Registration Number
- CTRI/2009/091/000857
- Lead Sponsor
- Amgen Technology Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 130
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 ¡Ü 30 days prior to enrollment or randomization
Serious or non-healing wound
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival (PFS), as measured by RECIST per local reviewTimepoint: 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
Name Time Method Cmax and Cmin for AMG 102; Cmax and AUC for epirubicin and cisplatin with or without AMG 102Timepoint: 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.Timepoint: 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;Overall survival, objective response rate, disease control rate, time to response (for responders only), and duration of response (for responders only).Timepoint: 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