Ascending Dose and Exploratory Expansion Study of DS-3032b, an Oral MDM2 Inhibitor, in Subjects With Relapsed and/or Refractory Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT02579824|
Recruitment Status : Recruiting
First Posted : October 20, 2015
Last Update Posted : September 18, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Myeloma||Drug: DS-3032b||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Ascending Dose and Exploratory Expansion Study of DS-3032b, an Oral MDM2 Inhibitor, in Subjects With Relapsed and/or Refractory Multiple Myeloma|
|Actual Study Start Date :||August 2016|
|Estimated Primary Completion Date :||August 2021|
|Estimated Study Completion Date :||August 2021|
Dose Escalation Phase: DS-3032b administered once daily by mouth on Days 1 - 21 of a 28 day cycle. Starting dose level 90 mg/day.
Dose Expansion Phase: Starting dose level maximum tolerated dose from Dose Escalation Phase.
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.
- Maximum Tolerated Dose (MTD) of DS-3032b in Participants with Relapsed and/or Refractory Myeloma [ Time Frame: 28 days ]MTD defined as the highest dose at which six subjects have been treated and less than two subjects experienced dose limiting toxicity (DLT) within the first cycle of treatment. DLT defined as any treatment-emergent adverse event (TEAE) not attributable to disease or disease-related processes that occurs during the observation period (Cycle 1) in each dose-level cohort per NCI-CTCAE v4.
- Response of DS-3032b in Participants with Relapsed and/or Refractory Myeloma [ Time Frame: Every 28 days while participant is on the study ]Response determined by the IMWG Uniform Response Criteria and updated uniform response criteria.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02579824
|Contact: Hans C. Lee, MD||713-792-2860|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Hans C. Lee, MD||M.D. Anderson Cancer Center|