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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00719550
• Other study ID #: 20060317
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 17, 2008
• Last updated: November 13, 2013
• Start date: February 2009
• Est. completion date: June 2013

Study information

• Verified date: November 2013
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug AdministrationUnited States: Western Institutional Review BoardPoland: Ministry of HealthSpain: Ministry of HealthItaly: Ministry of HealthGreece: Ministry of Health and WelfareRussia: Ministry of Health of the Russian FederationIndia: Ministry of HealthHong Kong: Department of HealthSingapore: Health Sciences AuthorityAustralia: National Health and Medical Research CouncilBelgium: Federal Agency for Medicinal Products and Health ProductsHungary: National Institute of Pharmacy
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: June 2013
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Esophageal Cancer
• Esophageal Neoplasms
• Esophagogastric Junction Adenocarcinoma
• Gastric Cancer

Intervention

Drug:
• Capecitabine
Administered at 625mg/m2 BID orally every day while on study.
• Epirubicin
Administered day 1 of each cycle at 50mg/m2 IV.
• AMG 102
Investigation product to be given at 15mg/kg, 7.5mg/kg, or 5mg/kg depending on assignment.
• Cisplatin
Administered day 1 of each cycle at 60mg/m2 IV.
• Placebo
AMG 102 placebo will be provided in similar vials as clear, colorless, sterile protein-free solution

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

References & Publications (6)

Doshi S, Loh E, Oliner K, Gisleskog PO, Perez Ruixo JJ, Zhang Y, Zhu M.Exposure survival modeling.Journal-001088;

Iveson 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. — View Citation

Oliner K.BM Ph2 Gastric.Journal-004521;

TBD.Ph2 Gastric Exposure Response.Journal-004521;

TBD.Ph2 Gastric PRO.Journal-004521;

Zhu.20060317 ER data.Journal-000728;

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival (PFS), as measured by RECIST per local review		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.	No
Secondary	Overall survival, objective response rate, disease control rate, time to response (for responders only), and duration of response (for responders only).		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.	No
Secondary	Incidence of adverse events, significant laboratory value changes form baseline and anti-AMG 102 antibody formation.		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.	Yes
Secondary	Cmax and Cmin for AMG 102; Cmax and AUC for epirubicin and cisplatin with or without AMG 102		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.	No

External Links

•   AmgenTrials clinical trials website