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

• Conditions: Advanced MET-Positive Gastric, Lower Esophageal or GastroesophagealJunction Adenocarcinoma; MedDRA version: 14.1Level: LLTClassification code 10066354Term: Adenocarcinoma of the gastroesophageal junctionSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: PTClassification code 10017761Term: Gastric cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: LLTClassification code 10017766Term: Gastric cancer stage IV NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: PTClassification code 10017765Term: Gastric cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-004923-11-IT
• Lead Sponsor: AMGEN INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-11
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

Disease Related
• Pathologically confirmed unresectable locally advanced or metastatic
gastric or GEJ adenocarcinoma; adenocarcinomas of the distal
esophagus within 5 cm of the GEJ are eligible
• ECOG performance status (0 or 1)
• Tumor MET-positive by IHC (fulfilling the MET IHC criteria as defined
by an investigational use only MET IHC assay) by protocol-specified
centralized testing
• Formalin fixed paraffin-embedded (FFPE) tumor tissue submission
required
• Evaluable (measurable or non-measurable) disease by RECIST 1.1
criteria
Demographic
• Men or women = 18 years of age
Ethical
• Before any study-specific procedure, the appropriate written
informed consent must be obtained (Section 11.1)
Laboratory
• Adequate organ function as evidenced by the following laboratory
studies within 28 days prior to randomization:
- Hemoglobin = 9 g/dL
- Absolute neutrophil count = 1.5 x 109/L
- Platelet count = 100 x 109/L
- Creatinine clearance = 60mL/minute (calculated or measured)
- Aspartate aminotransferase (AST) and alanine amino transferase (ALT)
= 2.5 x ULN or AST and ALT = 5.0 x ULN if liver metastases are present
- Total bilirubin = 1.5x ULN
General
• Able to tolerate infusions and take oral medications
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 290
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 160

Exclusion Criteria

Disease Related
• HER2-overexpressing locally advanced or metastatic gastric or GEJ
adenocarcinoma. Subjects whose tumor HER2 expression status is not
known must submit tumor samples for HER2 testing
• Previous systemic therapy (including chemotherapy, biologic,
immunotherapy, or investigational therapy) for locally advanced or
metastatic gastric or GEJ or lower esophageal (within 5 cm of GEJ)
adenocarcinoma Less than 6 months have elapsed from completion of
prior neoadjuvant or adjuvant chemotherapy or chemoradiotherapy to
randomization
• Previous treatment with anthracyclines exceeds total cumulative dose
of epirubicin of 400 mg/m2 (or equivalent thereof, if a different
anthracycline has been administered in the past)
• Subjects with ongoing toxicities from palliative radiotherapy, or who
have undergone radiotherapy to the only site of known disease, or
received palliative radiation = 14 days prior to randomization. Subjects
who received palliative
radiotherapy are otherwise eligible.
• Squamous cell histology
• Subjects with resectable disease or suitable for definitive
chemoradiation
• Plans for surgical resection or definitive chemoradiation based on
response to protocol therapy
• Subjects who have persistent gastric outlet obstruction, complete
dysphagia or are dependent upon jejunostomy for feeding
• Known central nervous system metastases
• Clinically significant upper gastro-intestinal bleeding < 30 days prior to
randomization
Other Medical Conditions
• Left ventricular ejection fraction (LVEF) < 50% as determined by
either multiple gated acquisition (MUGA) scan or echocardiogram
(ECHO)
• Documented myocardial infarction or unstable/uncontrolled cardiac
disease (eg, unstable angina, severe arrhythmias, congestive heart
failure [New York Heart Association (NYHA) > Class II]) within 6 months
before randomization (Appendix E)
• Presence of peripheral edema > grade 1
• Arterial thrombosis or vascular ischemic events, such as transient
ischemic attack, cerebral infarction, within six months prior to
randomization
• Subjects with venous thromboembolic events (including deep vein
thrombosis or pulmonary emboli) within 6 months prior to
randomization
• Serious or non-healing wound
• Known positive HepBsAg (indicative of acute or chronic Hepatitis B) or
detectable Hepatitis C virus (indicative of active Hepatitis C), known
positive test for HIV
• Known peripheral neuropathy > grade 1
• Known dihydropyrimidine dehydrogenase deficiency (DPD)
• History of any medical condition including cardiovascular disease or
chronic obstructive pulmonary disease (COPD), that in the opinion of the
investigator, may increase the risks associated with study participation
or study treatments or may interfere with the conduct of the study or
interpretation of study resultsMajor surgical procedure = 30 days before
randomization or not yet recovered from prior major surgery. Major
surgery is defined within this protocol as any surgical procedure that
involves general anesthesia and a significant incision (ie, larger than
what is required for placement of central venous access, percutaneous
feeding tube, or biopsy)
• Minor surgery (eg, catheter or gastrostomy tube placement) =14 days before randomization or not yet recovered from prior minor surgery.
Placement of central venous access device, fine needle aspiration,
thoracentesis, endoscopic biliary stent or paracentesis = 1 day before
randomizatio

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified