NL-OMON44939
Completed
Not Applicable
A phase 1 first-in-human study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of AMG232 in adult subjects with advanced solid tumors or multiple myeloma - Phase 1 study with AMG232 in adults with solid tumors or multiple myeloma
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- solide tumoren
- Sponsor
- Amgen
- Enrollment
- 42
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Men or women \>/\<\= 18 years old;Pathologically documented, definitively diagnosed, advanced solid tumor that is refractory to standard treatment or for which no standard therapy is available or the subject refuses standard therapy;Subjects with tumors showing evidence of wild\-type p53\.;ECOG performance status of 3 months, in the opinion of the investigator.;Able to take oral medications.;Voor een volledig overzicht van alle inclusiecriteria verwijs ik u naar paragraaf 4\.1 van het 20120106 protocol
Exclusion Criteria
- •Prior bone marrow transplant;History or presence of hematological malignancies;Myocardial infarction within 6 months of study day 1, symptomatic congestive heart failure, unstable angina or cardiac arrhythmia requiring medication.;Active infection requiring intravenous antibiotics within 2 weeks of study enrollment (day 1\).;Major surgery within 28 days of study day 1\.;Voor een volledig overzicht van alle exclusiecriteria verwijs ik u naar paragraaf 4\.2 van het 20120106 protocol
Outcomes
Primary Outcomes
Not specified
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