A Phase 1 Study of AMG 211 in Participants With Advanced Gastrointestinal Cancer

• Status: Terminated
• Trial end date: 2018-01-09
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this Phase 1 study is to determine if AMG 211 given as a continous intravenous (IV) infusion is safe and tolerable in adult participants that have advanced gastrointestinal adenocarcinoma. The study will be conducted in multiple sites and test increasing doses of AMG 211. The safety of participants will be monitored by intensive assessment of vital signs, electrocardiograms, physical examinations, and laboratory tests. Efficacy will be assessed by the usual imaging procedures and their interpretation.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Collaborator: MedImmune LLC

Criteria

Inclusion Criteria:

• Informed consent provided

• 18 years or older

• Advanced relapsed/refracted gastrointestinal adenocarcinoma

• At least 1 measurable tumor lesion

• Tumor tissue available or is willing to undergo biopsy of a tumor lesion before the start of treatment

• Adequate hematological, renal, and liver function

• Body weight ≥ 45 kg

• Other inclusion criteria may apply

Exclusion Criteria:

• Malignancy other than gastrointestinal (GI) adenocarcinoma requiring current therapy

• Evidence of uncontrolled systemic disease, active infection, Hepatitis B and/or C, human immunodeficiency virus (HIV), history of cardiac disease, history of significant central nervous system (CNS) disease, history of chronic autoimmune disease (with the exception of stable type 1 diabetes)

• Major surgery within 28 days of study day 1

• Currently receiving treatment in another investigational device or drug study, or less than 28 days since ending treatment in another investigational device or drug study. Other investigational procedures while participating in this study are excluded. Exception to this criterion is the participation in the optional Imaging Study and all procedures related to this study.

• Treatment with any chemotherapy, radiotherapy, immunotherapy, biologic, or hormonal therapy for cancer within 14 days prior to study entry and not recovered from treatment

• Unresolved toxicities from prior anti-tumor therapy

• Males or Females of reproductive potential, and unwilling to practice an acceptable method of effective birth control while on study through 30 days after receiving the last dose of study drug

• Females who are pregnant, planning to become pregnant, lactating/breastfeeding or who plan to breastfeed while on study through 30 days after receiving the last dose of study drug

• Other exclusion criteria may apply