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
- Conditions
- solide tumorentumor in the organs
- Registration Number
- NL-OMON44939
- Lead Sponsor
- Amgen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 42
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- To evaluate the safety and tolerability of AMG232 after multiple oral<br /><br>administrations in subjects with advanced solid tumors<br /><br>- To evaluate the pkarmacokinetics of AMG232<br /><br>- To determine the MTD of AMG232</p><br>
- Secondary Outcome Measures
Name Time Method <p>- To evaluate tumor response assessed by CT or MRI or Macdonald criteria (GMB<br /><br>subjects)<br /><br>- To evaluate the pharmacokinetics of the acyl glucuronide metabolite of AMG232<br /><br>in plasma<br /><br>- To evaluate the pharmacodynamic effects of AMG232 exposure on serum MIC-1<br /><br>levels, p21 induction and/or evidence of apoptosis<br /><br>- To evaluate the efficacy of AMG 232</p><br>