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Ascending Dose and Exploratory Expansion Study of DS-3032b, an Oral MDM2 Inhibitor, in Subjects With Relapsed and/or Refractory Multiple Myeloma

NCT02579824 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2019-11-15

No results posted yet for this study

Summary

This is a 2 part study: Part 1 (dose escalation) and Part 2 (dose expansion).

The goal of Part 1 of this clinical research study is to find the highest tolerable dose of DS-3032b that can be given to patients with multiple myeloma (MM) that is relapsed (has come back) and/or refractory (has not responded to treatment).

The goal of Part 2 of this clinical research study is to continue to study the safety of the highest tolerable dose found in Part 1 of the study.

Conditions

Interventions

DRUG

DS-3032b

Escalation DS-3032b starting dose level 90 mg/day administered once daily by mouth on Days 1 - 21 of a 28 day cycle. For Dose Expansion maximum tolerated dose from Dose Escalation Phase.

Sponsors & Collaborators

  • Daiichi Sankyo UK Ltd.

    collaborator OTHER

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Hans C. Lee, 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
2016-08-30
Primary Completion
2019-11-07
Completion
2019-11-07
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT02579824 on ClinicalTrials.gov