Study of DS-8201a in Subjects With Advanced Solid Malignant Tumors
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|ClinicalTrials.gov Identifier: NCT02564900|
Recruitment Status : Active, not recruiting
First Posted : October 1, 2015
Last Update Posted : December 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumors||Drug: DS-8201a||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||278 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||August 2015|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 2019|
Experimental: Part 1 Dose escalation
Part 1 is a dose escalation to identify the Maximum Tolerated dose (MTD) or the recommended phase 2 dose of DS-8201a guided by the modified continuous reassessment method using a Bayesian logistic regression model following escalation with overdose control principal.
Experimental: Part 2 Dose expansion
Part 2 is a dose expansion to examine the safety and efficacy of DS-8201a and it is consist of multiple cohorts: in subjects with trastuzumab emtansine (T-DM1)-treated HER2 overexpressing breast cancer (Part 2a); trastuzumab-treated HER2 overexpressing gastric or gastroesophageal junction adenocarcinoma (Part 2b); HER2 low expressing breast cancer (Part 2c), and HER2 expressing other solid malignant tumor (Part 2d)
- Number of subjects experiencing adverse events [ Time Frame: Day 1 through 28 days after last dose ]frequency and seriousness of treatment emergent adverse events (TEAEs).
- Tumor response using RECIST version 1.1 throughout study [ Time Frame: from randomization date until disease progresses, whichever comes first, up to 30 months ]RECIST = Response Evaluation Criteria In Solid Tumors Assessment of tumor response is conducted every 6 weeks in the first 24 weeks and thereafter every 12 weeks until progressive disease to evaluate the efficacy of DS-8201a up to 30 months.
- Change in the area under curve (AUC) of DS-8201a [ Time Frame: from first dose to Day 45 ]area under curve AUC at Cycle 1, Days 1, 2, 4, 8, 15; Cycles 2, 4, 6, and 8, Day 1; Cycle 3, Days 1, 8, 15.
- Change in the maximum plasma concentration (Cmax) of DS-8201a [ Time Frame: from first dose to Day 45 ]maximum plasma concentration Cmax at Cycle 1, Days 1, 2, 4, 8, 15; Cycles 2, 4, 6, and 8, Day 1; Cycle 3, Days 1, 8, 15.
- Change in the time of maximum plasma concentration (Tmax) of DS-8201a [ Time Frame: from first dose to Day 45 ]time of maximum plasma concentration Tmax at Cycle 1, Days 1, 2, 4, 8, 15; Cycles 2, 4, 6, and 8, Day 1; Cycle 3, Days 1, 8, 15.
- Change in the total anti-HER2 antibody [ Time Frame: from first dose to Day 45 ]Cycle 1, Days 1, 2, 4, 8, 15; Cycles 2, 4, 6, and 8, Day 1; Cycle 3, Days 1, 8, 15.
- Change in MAAA-1181 level [ Time Frame: from first dose to Day 45 ]determine the change in MAAA-1181 level from first dose to Day 45 at Cycle 1, Days 1, 2, 4, 8, 15; Cycles 2, 4, 6, and 8, Day 1; Cycle 3, Days 1, 8, 15.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02564900
|United States, California|
|Sharp Memorial Hospital|
|San Diego, California, United States, 92123|
|United States, Florida|
|Jacksonville, Florida, United States, 32224|
|United States, Kentucky|
|University of Louisville|
|Louisville, Kentucky, United States, 40202|
|United States, Massachusetts|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|United States, Ohio|
|UC Health Clinical Trials Office|
|Cincinnati, Ohio, United States, 45229|
|United States, Texas|
|University of Texas M. D. Anderson Cancer Center|
|Houston, Texas, United States, 77030-3721|
|Aichi Cancer Center Hospital|
|National Cancer Center Hospital East|
|Social Medical Corporation Hakuaikai Sagara Hospital|
|Kindai University Hospital|
|National Cancer Center Hospital|
|The Cancer Institute Hospital of Japanese Foundation For Cancer Research|
|Study Director:||Global Clinical Leader||Daiichi Sankyo, Inc.|