18 and older, any sex, with Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Maximum Tolerated Dose (MTD) (Phase l) of DS-3201/ValemetostatPrimary· 1 year
Will employ a standard 3-by-3 dose-escalation phase I study design to investigate the maximum tolerated dose (MTD) of DS-3201b/valemetostat in combination with fixed dose irinotecan. The study population for Phase I dose-escalation will include only patients who complete at least 1 full cycle of treatment (including the initial 7-day safety run-in and the complete 21-days of Cycle 1); only these patients will be considered evaluable for DLT and determination of the MTD.
Group
Value
95% CI
All Phase I Participants, Dose Level 1 & Dose Level 2
100
Objective Response Rate (ORR) (Phase II)Primary· 1 year
The Response Evaluation Criteria in Solid Tumors Group (RECIST v1.1) criteria will be used to evaluate the response to treatment
Group
Value
95% CI
Phase 2
21
6 – 46
Adverse events — posted to ClinicalTrials.gov
Time frame: 1 year.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study will test the safety of the study drug, DS-3201b, given in combination with irinotecan to people who have recurrent small cell lung cancer (SCLC).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
NCT04276662 — Study of Single-dose DS-3201b in Participants With Hepatic Impairment
· Phase 1
· completed
NCT03110354 — DS-3201b for Acute Myelogenous Leukemia (AML) or Acute Lymphocytic Leukemia (ALL)
· Phase 1
· terminated
NCT02732275 — DS-3201b in Participants With Lymphomas
· Phase 1
· active not recruiting
Other recruiting trials for Small Cell Lung Cancer
Currently open trials in the same condition.
NCT07476287 — Symbiotic-Lung-14: A Study to Learn About the Study Medicine Called PF08634404 in Combination With Chemotherapy in Adult
· Phase 2
· recruiting
NCT07296809 — SKB500 Combinations in Patients With Small Cell Lung Cancer
· Phase 2
· recruiting
NCT07155200 — Small Cell Lung Cancer Irinotecan and CDC2-like Kinase Inhibition Trial (SLICK Trial)
· Phase 1, PHASE2
· recruiting
NCT06922539 — ST-001 nanoFenretinide in Relapsed/ Refractory Small Cell Lung Cancer
· Phase 1
· recruiting
NCT07373964 — A Prospective, Single-Arm, Single-Center Phase II Study Evaluating the Efficacy and Safety of Chidamide Combined With PD
· Phase 2
· recruiting
Other Memorial Sloan Kettering Cancer Center trials
Trials by the same sponsor.
NCT07566377 — Cord Blood Transplantation in Children and Young Adults With Blood Cancer
· Phase 2
· recruiting
NCT07507643 — A Study of Methylprednisolone in People Having Liver Surgery
· Phase 3
· recruiting
NCT07483307 — A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer
· Phase 2
· recruiting
NCT07459673 — HERizon-Breast: A ctDNA-Guided Adaptive Study of Sequential Anti-HER2 Therapies and CNS Prophylaxis to Induce Long-Term
· Phase 2
· recruiting
NCT07449195 — A Study Comparing Two Optical Coherence Tomography Devices in People With Ocular Tumors
· NA
· recruiting
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center
Last refreshed: 10 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03879798.