Evaluate the safety and tolerability of AMG 211 in subjects with advanced gastrointestinal (GI) adenocarcinomas Determine the maximum tolerated dose (MTD) and/or biologically active dose
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Determinde the safety and tolerability of AMG 211;
Determine the MTD and or biologically active dose.
Secondary outcome
Describe the pharmacokinetics (PK) of AMG 211
Determine the formation of anti-AMG 211 antibodies
Evaluate the anti-tumor activity of AMG 211
Background summary
In this study AMG 211 is studied. The safety, tolerability and efficacy are
evaluated in subjects with gastrointestinal adenocarcinoma. The
pharmacokinetics and pharmacodynamics are also being evaluated in this patient
population.
AMG 211 is considered as an experimental drug. AMG 211 is not approved by any
regulatory organization to treat any type of cancer.
About 78 patients will participate in this study in Germany and The
Netherlands. Amgen Inc. is funding this clinical study.
Study objective
Evaluate the safety and tolerability of AMG 211 in subjects with advanced
gastrointestinal (GI) adenocarcinomas
Determine the maximum tolerated dose (MTD) and/or biologically active dose
Study design
This phase 1 study is performed in several hospitals. The Netherlands will
participate with 2 hospitals and Germany will participate with 3 hospitals.
Patients start the study after signing the informed consent. When the patient
is eligible the patient starts with the treatment phase (for about 4 months).
About four weeks after the end of treatment with AMG 211 the End of Study visit
will be performed.
Patients will receive an increasing dose/ increasing treatment period per
cohort. By doing this we want to determinde the MTD. The expansion phase will
begin when the MTD is known.
Intervention
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.
Study burden and risks
Risk:
Adverse events of the study medication AMG 211. During the visits to th
hospital the subjects will be monitored for adverse events.
Burden:
Study duratuon is about 6 months. The duration of each visit will be about 5
hours,
Minervum 7061
Breda 4800DH
NL
Minervum 7061
Breda 4800DH
NL
Listed location countries
Age
Inclusion criteria
Male or Female >/<= 18 years old;
Pathologically documented, diagnosed GI adenocarcinoma;
At least 1 measurable tumor lesion per mirRC.;Voor een volledig overzicht van alle inclusie criteria verwijs ik u naar paragraaf 4.1 van het 20130354 protocol.
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2014-000201-12-NL |
| ClinicalTrials.gov | NCT02291614 |
| CCMO | NL48544.042.14 |