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

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 - Phase 1 with AMG 211 in subjects with Gastrointestinal Adenocarcinoma

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44202

Enrollment

Registered

2014-05-27

Start date

2014-12-01

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal cancer

Interventions

Patients will receive diverse doses of AMG 211 with diverse treatment durations. The dose and schema in the expansionphase is dependent on the MTD that is determined in the first part of the study.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Male or Female >/

Exclusion criteria

Exclusion criteria: History of allergy or reaction to any component of the AMG 211 formulation; Active infection or prior use of IV antibiotics for treatment of infection within 2 weeks prior to starting therapy with AMG 211; Major surgery within 28 days of study day 1. Females with a positive pregnancy test.;Voor een volledig overzicht van alle inclusie criteria verwijs ik u naar paragraaf 4.2 van het 20130354 protocol.

Design outcomes

Primary

Measure	Time frame
Determinde the safety and tolerability of AMG 211; Determine the MTD and or biologically active dose.	—

Secondary

Measure	Time frame
Describe the pharmacokinetics (PK) of AMG 211 Determine the formation of anti-AMG 211 antibodies Evaluate the anti-tumor activity of AMG 211	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)