CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 292 enrolled
Drug / intervention
DS-8201a (DP1) +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02564900
NCT02564900Phase 1Completed
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Phase 1, Two-Part, Multicenter, Non-randomized, Open-label, Multiple Dose First-In-Human Study of DS-8201A, in Subjects With Advanced Solid Malignant Tumors

Daiichi Sankyo Co., Ltd.·interventional·Posted Oct 1, 2015·Updated Jan 22, 2024

In Brief

A Phase 1 clinical trial evaluating DS-8201a (DP1), DS-8201a (DP2), and 1 other intervention for Advanced Solid Tumors. Completed, enrolled 292 participants across 14 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Solid Tumors
CountriesJapan, United States
CollaboratorsDaiichi Sankyo, AstraZeneca

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 1, 2015
Enrollment StartSep 1, 2015
Primary CompletionFeb 1, 2019
Study CompletionDec 22, 2023
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 10.8 years ago

Interventions

DS-8201a (DP1)drug

DS-8201a to be administered via intravenous (IV) dose. DS-8201a (DP1) was used for the Dose Escalation phase and for Dose expansion Parts 2a, 2b, 2c, and 2d.

DS-8201a (DP2)drug

DS-8201a is to be administered via intravenous (IV) dose. DS-8201a (DP2) was used only used for Dose Expansion Part 2e.

DS-8201a (DP)drug

DS-8201a (DP) is to be administered via intravenous (IV) dose.