Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02564900 · ClinicalTrials.gov registry record · Phase 1
Study of DS-8201a in Subjects With Advanced Solid Malignant Tumors
A Phase 1 study of Advanced Solid Tumors, sponsored by Daiichi Sankyo Co..
- Completed
- Registry status
- Phase 1
- Development phase
- 292
- Enrollment target
- 14
- Study locations
NCT02564900: Completed Phase 1 study of Advanced Solid Tumors, sponsored by Daiichi Sankyo Co..
NCT02564900 is a Phase 1 study of Advanced Solid Tumors that has completed, run by Daiichi Sankyo Co.. The registered enrollment target is 292 participants, above the 197-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (48% higher). The trial reports 14 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02564900, a Phase 1 study of Advanced Solid Tumors, has completed, sponsored by Daiichi Sankyo Co..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 292 participants
- Enrollment target
- 14
- Study locations
Study Summary
This is an open-label, two-part, multicenter study to evaluate the safety and tolerability of DS-8201a in participants with advanced solid malignant tumors.
Primary Outcome
Objective response rate (ORR) by independent central review was defined as the proportion of participants who achieve either complete response \[CR\] or partial response \[PR\] per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. HER2-positive other solid tumors included participants with salivary/submandibular/parotid gland (8 participants),
Conditions Studied
Interventions
- DRUG DS-8201a (DP1)
- DRUG DS-8201a (DP2)
- DRUG DS-8201a (DP)
Study Locations (14)
Other
- Aichi Cancer Center Hospital - Aichi
- National Cancer Center Hospital East - Chiba
- Social Medical Corporation Hakuaikai Sagara Hospital - Kagoshima
- Kindai University Hospital - Osaka
- National Cancer Center Hospital - Tokyo
- The Cancer Institute Hospital of Japanese Foundation For Cancer Research - Tokyo
California
- Sharp Memorial Hospital - San Diego
Florida
- Mayo Clinic - Jacksonville
Kentucky
- University of Louisville - Louisville
Massachusetts
- Dana Farber Cancer Institute - Boston
Missouri
- Washington University School of Medicine - St Louis
New York
- Memorial Sloan-Kettering Cancer Center - New York
Ohio
- UC Health Clinical Trials Office - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 292 participants |
| Start Date | 2015-09-01 |
| Est. Completion | 2023-12-22 |
| Phase | Phase 1 |
What the finished NCT02564900 record still lists
NCT02564900 is an interventional study that assigns participants to a tested intervention. The registered 292 participants enrollment target is mid-sized for trials with a published cap, above the 197-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (48% higher).
The record links to 1 condition, with Advanced Solid Tumors appearing as the primary indexed condition, and to 3 interventions - of which DS-8201a (DP1) is the first listed.
NCT02564900 lists 14 locations in 9 states (Other, California, Florida).
Frequently Asked Questions
What is clinical trial NCT02564900 about?
NCT02564900 is a clinical study titled "Study of DS-8201a in Subjects With Advanced Solid Malignant Tumors". This is an open-label, two-part, multicenter study to evaluate the safety and tolerability of DS-8201a in participants with advanced solid malignant tumors.
What is the current status of trial NCT02564900?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 292 participants. The study started on 2015-09-01. Estimated completion is 2023-12-22.
What conditions does trial NCT02564900 study?
This clinical trial studies the following conditions: Advanced Solid Tumors.
What interventions are being tested in trial NCT02564900?
The interventions under investigation include: DS-8201a (DP1) (DRUG), DS-8201a (DP2) (DRUG), DS-8201a (DP) (DRUG).
Who is sponsoring clinical trial NCT02564900?
This trial is sponsored by Daiichi Sankyo Co., which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02564900 being conducted?
This trial has 14 study locations across California, Florida, Kentucky, Massachusetts, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Advanced Solid Tumors
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02564900's enrollment target sits among peer trials
292 28th of 144 higher than 117 of 144 other Advanced Solid Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Solid Tumors trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study of ASP1570 Taken by Itself, or ASP1570 Taken Together With Either Pembrolizumab, Standard Therapies, or Both, in Adults With Solid Tumors
RECRUITING · Phase 1
-
Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors
RECRUITING · Phase 1
-
Anti-Ly6E Exatecan ADC M7437 in Advanced Solid Tumors
RECRUITING · Phase 1
-
Dose Escalation and Expansion Study Evaluating ODC-IL2 in Adult Patients With Advanced or Metastatic Solid Tumors
RECRUITING · Phase 1
-
JAB-23E73 in Adult Participants With Advanced Solid Tumors With KRAS Alteration
RECRUITING · Phase 1
-
SNV4818 in Participants With Advanced Solid Tumors
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04429542 · 292 participants · Phase 1
Study of Safety and Tolerability of BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-driven Advanced Solid Tumors
- NCT05406622 · 292 participants · NA
MOTIV BTK Randomized Controlled Trial
- NCT05757102 · 292 participants · Phase 3
A Study to Compare the Efficacy, Safety and Tolerability of FF/UMEC/VI With FF/VI in 12-17-year-olds With Asthma
- NCT06569667 · 292 participants · NA
Using AI and Peer Coaching to Address Racial Disparities Among People Who Use Opioids
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI