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.

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000857

Enrollment

130

Registered

2009-10-20

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Esophagogastric Junction Adenocarcinoma Gastric Cancer Esophageal Cancer Health Condition 2: C169- Malignant neoplasm of stomach, unspecified

Interventions

Intervention1: Phase 1b Drug: Capecitabine,Epirubicin ,AMG 102 ,Cisplatin: Drug: Capecitabine Administered at 625mg/m2 BID orally every day while on study. Drug: Epirubicin Administered day 1 of ea

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Australia, Belgium, Canada, Greece, Hungary, India, Italy, Poland, Russian Federation, Singapore, Spain, United Kingdom, United States of America

Contacts

Public ContactDr Veena Jaguste

Amgen Technology Pvt. Ltd

tsawant@amgen.com91-22-67869301

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026