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

Amgen

Status and phase: Completed; Phase 2; Phase 1

Conditions: Esophageal Cancer; Gastric Cancer; Esophagogastric Junction Adenocarcinoma

Treatments: Drug: Placebo; Drug: Epirubicin; Drug: Cisplatin; Drug: Capecitabine; Drug: AMG 102

Study type: Interventional

Funder types: Industry

Identifiers

NCT00719550

20060317

Details and patient eligibility

About

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).

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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130 participants in 4 patient groups, including a placebo group

Phase 2 Arm C

Placebo Comparator group

Description:

AMG 102 placebo plus ECX

Treatment:

Drug: Placebo

Drug: Cisplatin

Drug: Epirubicin

Drug: Capecitabine

Phase 1b

Other group

Description:

Phase 1b dose study with open-labe AMG 102 at 15mg/kg de-escalating to 7.5mg/kg and 5mg/kg if needed.

Treatment:

Drug: AMG 102

Drug: Cisplatin

Drug: Epirubicin

Drug: Capecitabine

Phase 2 Arm B

Active Comparator group

Description:

AMG 102 at 7.5mg/kg plus ECX

Treatment:

Drug: AMG 102

Drug: Cisplatin

Drug: Epirubicin

Drug: Capecitabine

Phase 2 Arm A

Active Comparator group

Description:

AMG 102 at 15mg/kg plus ECX

Treatment:

Drug: AMG 102

Drug: Cisplatin

Drug: Epirubicin

Drug: Capecitabine