NCT02426723

Clinical Study of CWP232291 in Relapsed or Refractory Myeloma Patients

A Phase 1a/1b Multicenter, Open Label, Dose-Finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of CWP232291 Administered Intravenously Either Alone or in Combination With Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Myeloma (MM)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: JW Pharmaceutical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1a/1b, multicenter, open-label, two-part study in subjects with relapsed or refractory MM: * Phase 1a: single agent CWP232291. Dose-finding followed by cohort expansion at the maximum tolerated dose (MTD) or optimal dose as determined by the Safety Review Committee (SRC). * Phase 1b: CWP232291 in combination with lenalidomide and dexamethasone. Dose-finding followed by cohort expansion at the combination therapy MTD or optimal dose as determined by the SRC.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Phase 1a: CWP232291	CWP232291 administered alone twice weekly every 4 weeks.
DRUG	Phase 1b: CWP232291, Lenalidomide, Dexamethasone	CWP232291 administered twice weekly every 4 weeks. Lenalidomide and Dexamethasone administered per standard therapy.

Timeline

• Start date: 2015-10-19
• Primary completion: 2018-10-08
• Completion: 2018-10-26
• First posted: 2015-04-27
• Last updated: 2019-05-17

Locations

4 sites across 2 countries: United States, South Korea