AMG 102 Plus ECX for Unresectable Locally Advanced or Metastatic Gastric or Esophagogastric Junction Cancer

Phase 2CompletedNCT00719550

Amgen130 enrolled

Overview

Study Phase: 1b/2 Indication: Previously untreated subjects with unresectable locally advanced or metastatic gastric or esophagogastric junction adenocarcinoma. Primary Objective(s): Part 1: To identify safe dose levels of AMG 102, up to 15 mg/kg Q3W, to combine with ECX. Part 2 (phase 2-double-blind): To estimate with pre-specified precision the effect of the addition of AMG 102 to ECX on progression free survival (PFS).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

130

Conditions

Esophagogastric Junction Adenocarcinoma Gastric Cancer Esophageal Cancer

Interventions

CapecitabineDRUG

Administered at 625mg/m2 BID orally every day while on study.

EpirubicinDRUG

Administered day 1 of each cycle at 50mg/m2 IV.

AMG 102DRUG

Investigation product to be given at 15mg/kg, 7.5mg/kg, or 5mg/kg depending on assignment.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 ≤ 30 days prior to enrollment or randomization * Serious or non-healing wound

Outcomes

Primary Outcomes

Progression free survival (PFS), as measured by RECIST per local review

Time frame: 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 Outcomes

Overall survival, objective response rate, disease control rate, time to response (for responders only), and duration of response (for responders only).

Time frame: 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.

Time frame: 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.

Cmax and Cmin for AMG 102; Cmax and AUC for epirubicin and cisplatin with or without AMG 102

Time frame: 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.

Data from ClinicalTrials.gov

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