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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44939

Enrollment

Registered

2013-01-28

Start date

2013-06-24

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

solide tumoren tumor in the organs

Interventions

Patients will receive divers doses of AMG232 every 7 (part 1a) or 3 (part 1b) or 7 days (2x a day, part 1c) days every 3 weeks. The dose and schedule for part 2 is dependent of the results from part

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Men or women >/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

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

Design outcomes

Primary

Measure	Time frame
- To evaluate the safety and tolerability of AMG232 after multiple oral administrations in subjects with advanced solid tumors - To evaluate the pkarmacokinetics of AMG232 - To determine the MTD of AMG232	—

Secondary

Measure	Time frame
- To evaluate tumor response assessed by CT or MRI or Macdonald criteria (GMB subjects) - To evaluate the pharmacokinetics of the acyl glucuronide metabolite of AMG232 in plasma - To evaluate the pharmacodynamic effects of AMG232 exposure on serum MIC-1 levels, p21 induction and/or evidence of apoptosis - To evaluate the efficacy of AMG 232	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)