NCT02579824

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

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Study Groups: If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you join this study. Up to 3 groups of up to 6 participants each will be enrolled in Part 1 of the study, and up to 10 participants will be enrolled in Part 2. If you are enrolled in Part 1, the dose of DS-3032b you receive will depend on when you join this study. The first group of participants will receive the lowest dose level of DS-3032b. Each new group will receive a higher dose of DS-3032b than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of DS-3032b is found. If you are enrolled in Part 2, you will receive DS-3032b at the highest dose that was tolerated in Part 1. Study Drug Administration: You will take DS-3032b capsules by mouth 1 time each day on Days 1-21 of each 28-day study cycle. On Days 1, 8, and 15 of Cycle 1, you will take your morning dose of study drug at the clinic. You should take each dose of DS-3032b with at least 4 ounces of water about 2 hours before or 1 hour after a meal. If you miss or vomit a dose of study drug at home, you should not retake the missed or vomited dose. Wait and take the next scheduled dose. You should bring any empty bottles and unused study drug to the clinic at each visit. You will be given a diary to record when you take your study drug each day. Study Visits: On Day 1 of Cycle 1: * You will have a physical exam. * Blood (about 4 tablespoons) and urine will be collected for routine tests and to check the status of the disease. * You will have an EKG. * Blood (about 1 tablespoon) will be drawn for biomarker testing before your dose of study drug. If you have had some of these tests performed recently, you may not need to have them repeated. On Day 8 of Cycle 1: * You will have a physical exam. * Blood (about 2 tablespoons) will be drawn for routine tests. * Blood (about 1 tablespoon) will be drawn for pharmacokinetic (PK) and biomarker testing before your dose of study drug. PK testing measures the amount of study drug in the body at different time points. On Day 15 of Cycle 1: * You will have a physical exam. * Blood (about 2 tablespoons) and urine will be collected for routine tests. * You will have an EKG. On Day 1 of Cycle 2: * You will have a physical exam. * Blood (about 4 tablespoons) and urine will be collected for routine tests and to check the status of the disease. * You will have a bone marrow biopsy/aspiration to check the status of the disease and for biomarker testing. You may have this procedure performed at anytime between Day 24 of Cycle 1 and Day 5 of Cycle 2. On Days 8 and 15 of Cycle 2, blood (about 2 tablespoons) will be drawn for routine tests. On Day 1 of Cycle 3: * You will have a physical exam. * Blood (about 4 tablespoons) and urine will be collected for routine tests and to check the status of the disease. If you can become pregnant, this routine blood or urine collection will include a pregnancy test. On Day 1 of Cycles 4 and beyond: * You will have a physical exam. * Blood (about 4 tablespoons) will be drawn for routine tests and to check the status of the disease. * If the doctor thinks it is needed, you will have a bone survey. * If the doctor thinks it is needed, you will have a bone marrow biopsy and/or aspirate to check the status of the disease and for biomarker and cytogenetic testing. Length of Study: You may continue taking the study drug as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions. Your participation on this study will be over after you have completed follow-up. End-of-Treatment Visit: Within 30 days after your last dose of study drug: * You will have a physical exam. * Blood (about 4 tablespoons) and urine will be collected for routine tests and to check the status of the disease. If you can become pregnant, this routine collection will include a pregnancy test. Follow-Up Visit: About 30 days after your last dose of study drug, you will be contacted either by phone or during a clinic visit to find out what drugs you are taking and how you are doing. If you are called, it should take about 5 minutes. This is an investigational study. DS-3032b is not FDA approved or commercially available. It is currently being used for research purposes only. The study doctor can explain how the study drug is designed to work. Up to 28 participants will be enrolled in this study. All will take part at MD Anderson.

Conditions

• Myeloma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-08-30
• Primary completion: 2019-11-07
• Completion: 2019-11-07
• First posted: 2015-10-20
• Last updated: 2019-11-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study