Study of DS-8201a in Subjects With Advanced Solid Malignant Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02564900|
Recruitment Status : Active, not recruiting
First Posted : October 1, 2015
Last Update Posted : August 9, 2019
|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 :||March 2020|
|Estimated Study Completion Date :||March 2020|
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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.|