NCT03465540

Safety, Tolerability, Pharmacokinetics and Efficacy of AMG 397 in Subjects With Selected Relapsed or Refractory Hematological Malignancies

A Phase 1 Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of AMG 397 in Subjects With Selected Relapsed or Refractory Hematological Malignancies

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Evaluate the safety and tolerability of AMG 397. Estimate the maximum tolerated doses (MTDs) and/or biologically active doses.

Detailed description

This is a first-in-human (FIH), multicenter, non-randomized, open-label, phase 1 study evaluating AMG 397 administered orally once weekly, as part of a 28-day treatment cycle in adult subjects with selected relapsed or refractory hematological malignancies

Conditions

• Multiple Myeloma
• Acute Myeloid Leukemia
• Non-Hodgkins Lymphoma
• Myelodysplastic Syndrome
• AML
• MDS
• NHL

Interventions

Type	Name	Description
DRUG	AMG 397	AMG 397 will be administered orally once or twice weekly as part of a 28-day treatment cycle.
DRUG	Dexamethasone	Dexamethasone will be administered intravenously (IV) or orally on Days 1, 8, 15, and 22 of each 28-day cycle.
DRUG	Azacitidine	Azacitidine will be administered intravenously (IV) or subcutaneously (SC) daily for the first 7 days of a 28-day cycle.

Timeline

• Start date: 2018-08-17
• Primary completion: 2019-07-25
• Completion: 2019-07-25
• First posted: 2018-03-14
• Last updated: 2023-04-12
• Results posted: 2023-04-12

Locations

21 sites across 6 countries: United States, Australia, France, Greece, Italy, Japan

Regulatory

• FDA-regulated drug study