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

Amgen

Status and phase: Terminated; Phase 1

Conditions: GI Adenocarcinoma

Treatments: Drug: AMG 211

Study type: Interventional

Funder types: Industry

Identifiers

NCT02291614

20130354

2014-000201-12 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

45 participants in 11 patient groups

AMG 211 200 μg/day for 7/14 Days

Experimental group

Description:

In cycle 1 participants receive 200 µg/day AMG 211 administered as a continuous intravenous infusion (cIV) infusion at a constant flow rate for 7 days followed by a 3-week treatment-free interval. In cycle 2 and thereafter, participants receive 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.

Treatment:

Drug: AMG 211

AMG 211 200 μg/day for 14 Days

Experimental group

Description:

Participants receive 200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.

Treatment:

Drug: AMG 211

AMG 211 400 μg/day for 14 Days

Experimental group

Description:

Participants receive 400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.

Treatment:

Drug: AMG 211

AMG 211 800 μg/day for 14 Days

Experimental group

Description:

Participants receive 800 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.

Treatment:

Drug: AMG 211

AMG 211 1600 μg/day for 14 Days

Experimental group

Description:

Participants receive 1600 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.

Treatment:

Drug: AMG 211

AMG 211 1600 µg/day for 28 Days

Experimental group

Description:

Participants receive 1600 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.

Treatment:

Drug: AMG 211

AMG 211 3200 µg/day for 14 Days

Experimental group

Description:

Participants receive 3200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.

Treatment:

Drug: AMG 211

AMG 211 3200 µg/day for 28 Days

Experimental group

Description:

Participants receive 3200 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.

Treatment:

Drug: AMG 211

AMG 211 6400 µg/day for 14 Days

Experimental group

Description:

Participants receive 6400 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.

Treatment:

Drug: AMG 211

AMG 211 6400 µg/day for 28 Days

Experimental group

Description:

Participants receive 6400 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.

Treatment:

Drug: AMG 211

AMG 211 12,800 µg/day for 28 Days

Experimental group

Description:

Participants receive 12,800 µg/day AMG 211 administered as a cIV infusion for 28 days followed by a 2-week treatment-free interval.

Treatment:

Drug: AMG 211