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Clinical Study of CWP232291 in Relapsed or Refractory Myeloma Patients

NCT02426723 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2019-05-17

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Chang-Ki Min, MD · Seoul St. Mary's Hospital

  • Sung-Soo Yoon, MD · Seoul National University Hospital

  • Jin Seok Kim, MD · Severance Hospital

  • Elisabet Manasanch, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-19
Primary Completion
2018-10-08
Completion
2018-10-26

Countries

  • United States
  • South Korea

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02426723 on ClinicalTrials.gov