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Small Molecule
DS-3201b for Lymphoma
Phase 1
Waitlist Available
Research Sponsored by Daiichi Sankyo Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has hematocytological or pathological diagnosis of non-Hodgkin's lymphoma (NHL)
Has Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up witihn 5 years
Awards & highlights
Study Summary
This trial is currently enrolling in the US, South Korea, and Taiwan.
Who is the study for?
Adults with non-Hodgkin lymphoma whose disease has returned after remission or isn't responding to treatment may join. They must be of legal age, have good performance status (able to carry out daily activities), agree to use contraception, and provide tumor tissue samples. People with certain types of T-cell lymphoma or leukemia, CNS involvement, recent stem cell transplant, other serious diseases, pregnancy or breastfeeding are excluded.Check my eligibility
What is being tested?
DS-3201b is an experimental drug being tested in adults with advanced non-Hodgkin lymphoma. The study has three parts: finding a safe dose (Dose Escalation), assessing effectiveness for rare NHL types and collecting safety data (Dose Expansion), and studying how DS-3201b affects the body's handling of other drugs when taken together (DDI Cohort - US only).See study design
What are the potential side effects?
Specific side effects of DS-3201b aren't listed but could include typical reactions seen with cancer treatments such as nausea, fatigue, blood count changes leading to increased infection risk or bleeding tendencies. Participants will be monitored closely for any adverse reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with non-Hodgkin's lymphoma.
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I am fully active or can carry out light work.
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I am willing to provide tissue samples from my tumor for testing.
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My cancer came back or didn't respond after at least 1 treatment.
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I am legally an adult in my country.
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My ATL is acute, lymphomatous, or chronic with a poor outlook.
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My condition did not improve with standard treatment or there is no standard treatment available.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
DDI cohort only: Area under the plasma concentration time curve during the dosing interval (AUCtau) for DS-3201, midazolam, digoxin
DDI cohort only: Area under the plasma concentration time curve up to the last quantifiable time (AUClast) for DS-3201,midazolam,digoxin
Digoxin
+9 moreSecondary outcome measures
Best overall response, based on international consensus criteria
Disease control rate (DCR)
Duration of response (DOR)
+5 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: DS-3201bExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DS-3201b
2019
Completed Phase 1
~30
Find a Location
Who is running the clinical trial?
Daiichi SankyoIndustry Sponsor
396 Previous Clinical Trials
418,899 Total Patients Enrolled
Daiichi Sankyo, Inc.Industry Sponsor
389 Previous Clinical Trials
420,376 Total Patients Enrolled
Daiichi Sankyo Co., Ltd.Lead Sponsor
115 Previous Clinical Trials
48,985 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with a specific type of skin or blood cancer.I have taken certain medications that affect liver enzymes or heart medication in the last 14 days.I am fully active or can carry out light work.I am willing to provide tissue samples from my tumor for testing.My cancer came back or didn't respond after at least 1 treatment.I do not have any serious health or mental conditions that could worsen by joining this study.I have not taken any drugs or treatments that the study does not allow.I have been treated with EZH inhibitors before.I had a stem cell transplant from a donor within the last 3 months.I have been diagnosed with non-Hodgkin's lymphoma.I am legally an adult in my country.My organ functions are normal according to my recent tests.I am willing to give a fresh tissue sample at the end of my treatment.My ATL is acute, lymphomatous, or chronic with a poor outlook.My cancer has spread to my brain or spinal cord.My condition did not improve with standard treatment or there is no standard treatment available.
Research Study Groups:
This trial has the following groups:- Group 1: DS-3201b
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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