Back to results

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

Primary Purpose

GI Adenocarcinoma

Status

Terminated

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

AMG 211

About this trial

This is an interventional treatment trial for GI Adenocarcinoma focused on measuring Amgen, Phase 1, Clinical Trial, Oncology, GI adenocarcinoma, Immunotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Research Site
Research Site
Research Site
Research Site
Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm Type

Experimental

Arm Label

AMG 211 200 μg/day for 7/14 Days

AMG 211 200 μg/day for 14 Days

AMG 211 400 μg/day for 14 Days

AMG 211 800 μg/day for 14 Days

AMG 211 1600 μg/day for 14 Days

AMG 211 1600 µg/day for 28 Days

AMG 211 3200 µg/day for 14 Days

AMG 211 3200 µg/day for 28 Days

AMG 211 6400 µg/day for 14 Days

AMG 211 6400 µg/day for 28 Days

AMG 211 12,800 µg/day for 28 Days

Arm 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.

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

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

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

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

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

Number of Participants With Dose-Limiting Toxicities (DLTs)

A DLT was defined as any of the following occurring during the first 28 days of treatment and regarded by the investigator and/or sponsor as related to AMG 211. Hematological DLTs: absolute neutrophil count (ANC) < 0.5 × 10⁹ cells/L for ≥ 7 days; febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infection) with ANC < 0.5 × 10⁹ cells/L and fever ≥ 38.5°C; platelets < 25 × 10⁹ cells/L ≥ 7 days. Non-hematological DLTs: any AMG 211-related ≥ grade 3 non-hematological toxicity, excluding nausea and vomiting not refractory to anti-emetics, flare-up of pain due to potential increase in tumor volume, cytokine release syndrome manageable with symptomatic treatment and/or infusion interruption of up to 2 days. The Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 was used to assess toxicities/adverse events.

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

An adverse event (AE) was defined as any untoward medical occurrence, which does not necessarily have a causal relationship with study treatment. A serious adverse event (SAE) was defined as an event that: was fatal or life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/borth defect; or other significant medical event. A TEAE was defined as any AE starting on or after the first dose of study drug and up to and including 30 days after the end of last dose of study drug. The severity of each adverse event was graded using CTCAE version 4.03 criteria (1=mild, 2=moderate, 3=severe, 4=life-threatining, 5=death). 'Any TEAE' includes both serious and non-serious TEAEs.

Secondary Outcome Measures

Maximum Observed Concentration (Cmax) of AMG 211 in Cycle 1 in Participants Who Received Dosing for 7 or 14 Days

Levels of AMG 211 in plasma samples collected during this study were analyzed using an electrochemiluminiscence assay. The lower limit of quantification (LLOQ) of the assay was 0.10 ng/mL.

Maximum Observed Concentration (Cmax) of AMG 211 in Cycle 1 in Participants Who Received Dosing for 28 Days

Area Under the Serum Concentration-Time Curve (AUC) From Time 0 to the Last Quantifiable Concentration in Cycle 1 in Participants Who Received Dosing for 7 or 14 Days

Area under the serum concentration-time curve (AUC) from time 0 to the last quantifiable concentration was estimated using the linear trapezoidal method.

Area Under the Serum Concentration-Time Curve (AUC) From Time 0 to the Last Quantifiable Concentration in Cycle 1 in Participants Who Received Dosing for 28 Days

Area under the serum concentration-time curve (AUC) from time 0 to the last quantifiable concentration was estimated using the linear trapezoidal method.

Area Under the Serum Concentration-Time Curve From Time 0 to Infinity (AUCinf) in Cycle 1 in Participants Who Received Dosing for 7 or 14 Days

Area under the serum concentration-time curve from time 0 to infinity was estimated using the linear trapezoidal method

Area Under the Serum Concentration-Time Curve From Time 0 to Infinity (AUCinf) in Cycle 1 in Participants Who Received Dosing for 28 Days

Area under the serum concentration-time curve from time 0 to infinity was estimated using the linear trapezoidal method

Terminal Half-life (T1/2) of AMG-211 in Cycle 1 in Participants Who Received Dosing for 7 or 14 Days

Terminal half-life (t1/2,z) calculated as t1/2,z = ln(2)/λz, where λz was the first-order terminal rate constant estimated via linear regression of the terminal log-linear phase.

Terminal Half-life of AMG-211 in Cycle 1 in Participants Who Received Dosing for 28 Days

Terminal half-life (t1/2,z) calculated as t1/2,z = ln(2)/λz, where λz was the first-order terminal rate constant estimated via linear regression of the terminal log-linear phase.

Concentration of AMG 211 at Steady State (Css) in Cycle 1 in Participants Who Received Dosing for 7 or 14 Days

Css was calculated as the average concentration between achievement of plateau and the end of infusion.

Concentration of AMG 211 at Steady State (Css) in Cycle 1 in Participants Who Received Dosing for 28 Days

Css was calculated as the average concentration between achievement of plateau and the end of infusion.

Serum Clearance of AMG 211 in Cycle 1 in Participants Who Received Dosing for 7 or 14 Days

Serum clearance (CL) calculated as CL = (actual dose)/(serum concentrations at steady-state [Css] x 24).

Serum Clearance of AMG 211 in Cycle 1 in Participants Who Received Dosing for 28 Days

Serum clearance (CL) calculated as CL = (actual dose)/(serum concentrations at steady-state [Css] x 24).

Volume of Distribution at Steady-state (Vss) in Cycle 1 in Participants Who Received Dosing for 7 or 14 Days

Volume of distribution at steady-state calculated as (CL x t1/2,z)/0.693.

Volume of Distribution at Steady-state (Vss) in Cycle 1 in Participants Who Received Dosing for 28 Days

Volume of distribution at steady-state calculated as (CL x t1/2,z)/0.693.

Number of Participants With Anti-AMG 211 Antibody Formation

Blood samples collected during the study were tested for anti-AMG 211 binding antibodies using an electrochemiluminescence-based bridging immunoassay. The number of participants with anti-AMG 211 antibody formation includes participants with a negative or no result at baseline and a positive antibody binding result postbaseline.

Number of Participants With an Overall Objective Response

Disease response was assessed by radiological imaging using standardized contrast-enhanced magnetic imaging (MRI) or computed tomography (CT), and evaluated according to the modified Immune-Related Response Criteria (irRC). Overall objective response was defined as a best response of immune-related Complete Response (irCR) or immune-related Partial Response (irPR), confirmed by a repeat, consecutive assessment no less than 4 weeks from the date of the first documented assessment. irCR: Complete disappearance of all lesions and no new lesions. irPR: Decrease in tumor burden ≥ 50% relative to baseline.

Duration of Response

Duration of response was defined as the number of days between the date of the first tumor assessment indicating an objective response through to the subsequent date of progression as classified by modified irRC or death due to any cause. Analyzed in participants with an overall objective response. Overall objective response was defined as a best response of immune-related Complete Response (irCR) or immune-related Partial Response (irPR), confirmed by a repeat, consecutive assessment no less than 4 weeks from the date of the first documented assessment. irCR: Complete disappearance of all lesions and no new lesions. irPR: Decrease in tumor burden ≥ 50% relative to baseline.

Time to Response

Time to response was defined as the number of days from the first administration of AMG 211 to the first objective assessment of response as per modified irRC. Analyzed in participants with an overall objective response. Overall objective response was defined as a best response of immune-related Complete Response (irCR) or immune-related Partial Response (irPR), confirmed by a repeat, consecutive assessment no less than 4 weeks from the date of the first documented assessment. irCR: Complete disappearance of all lesions and no new lesions. irPR: Decrease in tumor burden ≥ 50% relative to baseline.

Time to Tumor Progression in Participants Treated at the Maximum Tolerated Dose (MTD)

Disease was assessed by radiological imaging using standardized contrast-enhanced MRI or CT, and evaluated according to the modified irRC. Immune-related progressed disease (irPD) was defined as an increase in tumor burden ≥ 25% relative to nadir (minimum recorded tumor burden), confirmed by a repeat, consecutive assessment no less than 4 weeks from the date of the first documented assessment.

Progression Free Survival (PFS) at 6 Months in Participants Treated at the MTD

PFS was defined as the percentage of participants who were progression-free at 6 months. Immune-related progressed disease (irPD) was defined as an increase in tumor burden ≥ 25% relative to nadir (minimum recorded tumor burden), confirmed by a repeat, consecutive assessment no less than 4 weeks from the date of the first documented assessment.

Full Information

NCT ID

NCT02291614

First Posted

November 6, 2014

Last Updated

February 23, 2021

Sponsor

Amgen

Collaborators

MedImmune LLC

1. Study Identification

Unique Protocol Identification Number

NCT02291614

Brief Title

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

Official Title

A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 211 Administered as Continuous Intravenous Infusion in Subjects With Relapsed/Refractory Gastrointestinal Adenocarcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Terminated

Why Stopped

The study was terminated because of immunogenicity and business decision.

Study Start Date

November 27, 2014 (Actual)

Primary Completion Date

November 6, 2017 (Actual)

Study Completion Date

January 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Amgen

Collaborators

MedImmune LLC

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

GI Adenocarcinoma

Keywords

Amgen, Phase 1, Clinical Trial, Oncology, GI adenocarcinoma, Immunotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AMG 211 200 μg/day for 7/14 Days

Arm Type

Experimental

Arm Description

Arm Title

AMG 211 200 μg/day for 14 Days

Arm Type

Experimental

Arm Description

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

Arm Title

AMG 211 400 μg/day for 14 Days

Arm Type

Experimental

Arm Description

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

Arm Title

AMG 211 800 μg/day for 14 Days

Arm Type

Experimental

Arm Description

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

Arm Title

AMG 211 1600 μg/day for 14 Days

Arm Type

Experimental

Arm Description

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

Arm Title

AMG 211 1600 µg/day for 28 Days

Arm Type

Experimental

Arm Description

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

Arm Title

AMG 211 3200 µg/day for 14 Days

Arm Type

Experimental

Arm Description

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

Arm Title

AMG 211 3200 µg/day for 28 Days

Arm Type

Experimental

Arm Description

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

Arm Title

AMG 211 6400 µg/day for 14 Days

Arm Type

Experimental

Arm Description

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

Arm Title

AMG 211 6400 µg/day for 28 Days

Arm Type

Experimental

Arm Description

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

Arm Title

AMG 211 12,800 µg/day for 28 Days

Arm Type

Experimental

Arm 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.

Intervention Type

Drug

Intervention Name(s)

AMG 211

Other Intervention Name(s)

MEDI-565, MT111

Intervention Description

continuous intravenous infusion (cIV) infusion in cycles from 7 to 28 days

Primary Outcome Measure Information:

Title

Number of Participants With Dose-Limiting Toxicities (DLTs)

Description

Time Frame

28 days

Title

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Description

Time Frame

From first dose of study drug through end of treatment + 30 days (median time frame was 75.5 days).

Secondary Outcome Measure Information:

Title

Maximum Observed Concentration (Cmax) of AMG 211 in Cycle 1 in Participants Who Received Dosing for 7 or 14 Days

Description

Levels of AMG 211 in plasma samples collected during this study were analyzed using an electrochemiluminiscence assay. The lower limit of quantification (LLOQ) of the assay was 0.10 ng/mL.

Time Frame

Cycle 1: Predose, 2, 6, 24, 48-96, and 168 (for 14-day dosing groups only) hours after the start of infusion, at the end of infusion (Day 8 or Day 15), and 0.5, 2, 4, 8, and 24 hours after the end of infusion.

Title

Maximum Observed Concentration (Cmax) of AMG 211 in Cycle 1 in Participants Who Received Dosing for 28 Days

Time Frame

Cycle 1: Predose, 2, 6, 24, 48-96, and 168 hours after the start of infusion, Day 15, at the end of infusion (Day 29), and 0.5, 2, 4, 8, and 24 hours after the end of infusion.

Title

Area Under the Serum Concentration-Time Curve (AUC) From Time 0 to the Last Quantifiable Concentration in Cycle 1 in Participants Who Received Dosing for 7 or 14 Days

Description

Area under the serum concentration-time curve (AUC) from time 0 to the last quantifiable concentration was estimated using the linear trapezoidal method.

Time Frame

Title

Area Under the Serum Concentration-Time Curve (AUC) From Time 0 to the Last Quantifiable Concentration in Cycle 1 in Participants Who Received Dosing for 28 Days

Description

Area under the serum concentration-time curve (AUC) from time 0 to the last quantifiable concentration was estimated using the linear trapezoidal method.

Time Frame

Cycle 1: Predose, 2, 6, 24, 48-96, and 168 hours after the start of infusion, Day 15, at the end of infusion (Day 29), and 0.5, 2, 4, 8, and 24 hours after the end of infusion.

Title

Area Under the Serum Concentration-Time Curve From Time 0 to Infinity (AUCinf) in Cycle 1 in Participants Who Received Dosing for 7 or 14 Days

Description

Area under the serum concentration-time curve from time 0 to infinity was estimated using the linear trapezoidal method

Time Frame

Title

Area Under the Serum Concentration-Time Curve From Time 0 to Infinity (AUCinf) in Cycle 1 in Participants Who Received Dosing for 28 Days

Description

Area under the serum concentration-time curve from time 0 to infinity was estimated using the linear trapezoidal method

Time Frame

Cycle 1: Predose, 2, 6, 24, 48-96, and 168 hours after the start of infusion, Day 15, at the end of infusion (Day 29), and 0.5, 2, 4, 8, and 24 hours after the end of infusion.

Title

Terminal Half-life (T1/2) of AMG-211 in Cycle 1 in Participants Who Received Dosing for 7 or 14 Days

Description

Terminal half-life (t1/2,z) calculated as t1/2,z = ln(2)/λz, where λz was the first-order terminal rate constant estimated via linear regression of the terminal log-linear phase.

Time Frame

Title

Terminal Half-life of AMG-211 in Cycle 1 in Participants Who Received Dosing for 28 Days

Description

Terminal half-life (t1/2,z) calculated as t1/2,z = ln(2)/λz, where λz was the first-order terminal rate constant estimated via linear regression of the terminal log-linear phase.

Time Frame

Cycle 1: Predose, 2, 6, 24, 48-96, and 168 hours after the start of infusion, Day 15, at the end of infusion (Day 29), and 0.5, 2, 4, 8, and 24 hours after the end of infusion.

Title

Concentration of AMG 211 at Steady State (Css) in Cycle 1 in Participants Who Received Dosing for 7 or 14 Days

Description

Css was calculated as the average concentration between achievement of plateau and the end of infusion.

Time Frame

Title

Concentration of AMG 211 at Steady State (Css) in Cycle 1 in Participants Who Received Dosing for 28 Days

Description

Css was calculated as the average concentration between achievement of plateau and the end of infusion.

Time Frame

Cycle 1: Predose, 2, 6, 24, 48-96, and 168 hours after the start of infusion, Day 15, at the end of infusion (Day 29), and 0.5, 2, 4, 8, and 24 hours after the end of infusion.

Title

Serum Clearance of AMG 211 in Cycle 1 in Participants Who Received Dosing for 7 or 14 Days

Description

Serum clearance (CL) calculated as CL = (actual dose)/(serum concentrations at steady-state [Css] x 24).

Time Frame

Title

Serum Clearance of AMG 211 in Cycle 1 in Participants Who Received Dosing for 28 Days

Description

Serum clearance (CL) calculated as CL = (actual dose)/(serum concentrations at steady-state [Css] x 24).

Time Frame

Cycle 1: Predose, 2, 6, 24, 48-96, and 168 hours after the start of infusion, Day 15, at the end of infusion (Day 29), and 0.5, 2, 4, 8, and 24 hours after the end of infusion.

Title

Volume of Distribution at Steady-state (Vss) in Cycle 1 in Participants Who Received Dosing for 7 or 14 Days

Description

Volume of distribution at steady-state calculated as (CL x t1/2,z)/0.693.

Time Frame

Title

Volume of Distribution at Steady-state (Vss) in Cycle 1 in Participants Who Received Dosing for 28 Days

Description

Volume of distribution at steady-state calculated as (CL x t1/2,z)/0.693.

Time Frame

Cycle 1: Predose, 2, 6, 24, 48-96, and 168 hours after the start of infusion, Day 15, at the end of infusion (Day 29), and 0.5, 2, 4, 8, and 24 hours after the end of infusion.

Title

Number of Participants With Anti-AMG 211 Antibody Formation

Description

Time Frame

Predose and 24 hours after the end of infusion during each treatment cycle, until 4 weeks after the last dose. Median time frame was 75.5 days.

Title

Number of Participants With an Overall Objective Response

Description

Time Frame

Disease response was assessed every second cycle (8-10 weeks) until 4 weeks after the last dose. The median time frame was 75.5 days.

Title

Duration of Response

Description

Time Frame

Disease response was assessed every second cycle (8-10 weeks) until 4 weeks after the last dose. The median time frame was 75.5 days.

Title

Time to Response

Description

Time Frame

Disease response was assessed every second cycle (8-10 weeks) until 4 weeks after the last dose. The median time frame was 75.5 days.

Title

Time to Tumor Progression in Participants Treated at the Maximum Tolerated Dose (MTD)

Description

Time Frame

From first dose of AMG 211 until tumor progression, assessed through the end of study (up to 4 weeks after the last dose). The median time frame was 75.5 days.

Title

Progression Free Survival (PFS) at 6 Months in Participants Treated at the MTD

Description

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Organizational Affiliation

Amgen

Official's Role

Study Director

Facility Information:

Facility Name

Research Site

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

Research Site

City

München

ZIP/Postal Code

81377

Country

Germany

Facility Name

Research Site

City

Ulm

ZIP/Postal Code

89081

Country

Germany

Facility Name

Research Site

City

Amsterdam

ZIP/Postal Code

1081 HV

Country

Netherlands

Facility Name

Research Site

City

Groningen

ZIP/Postal Code

9713 GZ

Country

Netherlands

12. IPD Sharing Statement

Links:

URL

http://www.amgentrials.com

Description

AmgenTrials clinical trials website

Learn more about this trial

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

We'll reach out to this number within 24 hrs