Clinical trial · Interventional

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

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

NCT00719550CI-TRIAL-00012882completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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).

Conditions

Conditions (3)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Esophageal Cancer	Malignant Esophageal Neoplasm	CURATED_EXACT	0.92
Esophagogastric Junction Adenocarcinoma	Gastroesophageal Junction Adenocarcinoma	ALIAS	0.90
Gastric Cancer	Malignant Gastric Neoplasm	CURATED_BROADER	0.80

Interventions

Interventions (5)

Intervention	Type	Mapped drug	Match
AMG 102	Drug	Rilotumumab	ALIAS
Capecitabine	Drug	Capecitabine	ALIAS
Cisplatin	Drug	Cisplatin	ALIAS
Epirubicin	Drug	Epirubicin	ALIAS
Placebo	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (4)

type
PLACEBO_COMPARATOR
label
Phase 2 Arm C
description
AMG 102 placebo plus ECX
interventionNames
1. Drug: Capecitabine
2. Drug: Epirubicin
3. Drug: Cisplatin
4. Drug: Placebo
type
OTHER
label
Phase 1b
description
Phase 1b dose study with open-labe AMG 102 at 15mg/kg de-escalating to 7.5mg/kg and 5mg/kg if needed.
interventionNames
1. Drug: Capecitabine
2. Drug: Epirubicin
3. Drug: AMG 102
4. Drug: Cisplatin
type
ACTIVE_COMPARATOR
label

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (6)

BACKGROUNDDoshi S, Loh E, Oliner K, Gisleskog PO, Perez Ruixo JJ, Zhang Y, Zhu M.Exposure survival modeling.Journal-001088;
BACKGROUNDIveson T, Donehower RC, Davidenko I, Tjulandin S, Deptala A, Harrison M, Nirni S, Lakshmaiah K, Thomas A, Jiang Y, Zhu M, Tang R, Anderson A, Dubey S, Oliner KS, Loh E. Rilotumumab in combination with epirubicin, cisplatin, and capecitabine as first-line treatment for gastric or oesophagogastric junction adenocarcinoma: an open-label, dose de-escalation phase 1b study and a double-blind, randomised phase 2 study. Lancet Oncol. 2014 Aug;15(9):1007-18. doi: 10.1016/S1470-2045(14)70023-3. Epub 2014 Jun 22. PMID 24965569
BACKGROUNDOliner K.BM Ph2 Gastric.Journal-004521;
BACKGROUNDTBD.Ph2 Gastric Exposure Response.Journal-004521;
BACKGROUNDTBD.Ph2 Gastric PRO.Journal-004521;
BACKGROUNDZhu.20060317 ER data.Journal-000728;