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
Completed
- Conditions
- Gastrointestinal cancer10017990
- Registration Number
- NL-OMON44202
- Lead Sponsor
- Amgen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 31
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Determinde the safety and tolerability of AMG 211;<br /><br>Determine the MTD and or biologically active dose.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Describe the pharmacokinetics (PK) of AMG 211<br /><br>Determine the formation of anti-AMG 211 antibodies<br /><br>Evaluate the anti-tumor activity of AMG 211</p><br>