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Tyrosine Kinase Inhibitor

DS-3201b for Small Cell Lung Cancer

Phase 1 & 2

Waitlist Available

Led By Charles Rudin, MD, PhD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adequate hematologic and end-organ function

Concurrent consent to the appropriate biospecimen research protocols at MSKCC (#06-107 Storage and Research Use of Human Biospecimens) and at JHU

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial will study the safety of DS-3201b when given with irinotecan to people with small cell lung cancer that has come back.

Eligible Conditions

Small Cell Lung Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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Your blood and organs are working well enough to participate in the study.

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You agree to allow the study team to collect and use your biological samples for research purposes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

maximum tolerated dose (MTD) (Phase l)

objective response rate (ORR) (Phase II)

Trial Design

1Treatment groups

Experimental Treatment

Group I: DS-3201b and IrinotecanExperimental Treatment2 Interventions

The first part of this study is a phase I trial to assess the safety and tolerability of DS-3201b in combination with fixed-dose irinotecan. The second part of this study will be an open label, single-arm phase II study of DS-3201b at the established recommended phase II dose (RP2D) in combination with fixed-dose irinotecan. Dose-Escalation, which enrolled a total of 12 patients at MSK, is completed. Phase 1 of this study determined that the highest and safest dose of DS-3201b in patients was 100 mg daily.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

irinotecan

2002

Completed Phase 3

~3930

DS-3201b

2019

Completed Phase 2

~50

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,357 Total Patients Enrolled

Charles Rudin, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

W. Victoria Lai, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any antecedent studies involving DS-3201b?

"Presently, there are 263 studies actively researching DS-3201b with 53 of them in their final stage. The bulk of these investigations take place in Woolloongabba, Queensland but the drug is being researched at 8589 locations around the globe."

Answered by AI

Are there any vacancies remaining in this clinical trial?

"Per research on clinicaltrials.gov, this medical study is not presently recruiting participants. The trial was first put online on March 15th 2019 and last modified on August 31st 2022. Nonetheless, there are currently 1840 other clinical trials that require volunteers at the moment."

Answered by AI

In what circumstances is DS-3201b typically prescribed for therapeutic purposes?

"DS-3201b is an effective therapy for malignant neoplasms of the pancreas, metastatic cancerous growths, and stomach cancers."

Answered by AI

How many participants have joined this medical investigation?

"This clinical study is no longer recruiting participants; it was initially announced on March 15th 2019 and ceased accepting patients on August 31st 2022. On the other hand, there are currently 1,577 trials for lung cancer treatment and 263 studies searching for DS-3201b volunteers."

Answered by AI

How many venues are participating in this experiment?

"Eight different medical centers are currently running this trial, located in Montvale, Commack and Harrison among other cities. To reduce commute demands for participants, we advise selecting the nearest site possible."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

DS-3201b and Irinotecan for Patients With Recurrent Small Cell Lung Cancer

2019. "DS-3201b and Irinotecan for Patients With Recurrent Small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03879798.