Spots Global Cancer Trial Database for Study of DS-8201a for Participants With Advanced Solid Malignant Tumors
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Trial Identification
Brief Title: Study of DS-8201a for Participants With Advanced Solid Malignant Tumors
Official Title: A Phase 1, Multicenter, Open-label, Single Sequence Crossover Study to Evaluate Drug-drug Interaction Potential of OATP1B/CYP3A Inhibitor on the Pharmacokinetics of DS-8201a in Subjects With HER2-expressing Advanced Solid Malignant Tumors
Study ID: NCT03383692
Conditions
Study Description
Brief Summary: HER2-positive cancer is a cancer that tests positive for a protein called human epidermal growth factor receptor 2 (HER2). HER2 promotes the growth of certain cancer cells. This study will test an experimental drug called DS-8201a that has not been approved by the health authorities yet. DS-8201a will be tested for safety in patients with advanced solid malignant tumors that test positive for HER2. It also will test how DS-8201a moves within the body (pharmacokinetics).
Detailed Description: The expected time from the first subject's enrollment until the last subject's enrollment is approximately 8.5 months. The screening period is 28 days and each cycle of treatment is 21 days. The data for the primary analysis will cutoff after all subjects have either discontinued the study or completed at least 3 cycles, whichever comes first. After the primary analysis, the main study will be closed and transition to the extension period. Depending on the preliminary results of Cohort 1, Sponsor may decide whether Cohort 2 will be opened or not. The number of treatment cycles is not fixed in this study. Subjects who continue to derive clinical benefit from the study drug in the absence of withdrawal of consent, progressive disease (PD), or unacceptable toxicity may continue the study drug.
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Hokkaido Cancer Center, Sapporo, Hokkaido, Japan
Hokkaido University Hospital, Sapporo, Hokkaido, Japan
Kobe University Hospital, Kobe, Hyogo, Japan
Hamamatsu University Hospital, Hamamatsu, Shizuoka, Japan
Shizuoka Cancer Center, Nagaizumicho, Shizuoka, Japan
National Cancer Center Hospital, Chuo Ku, Tokyo, Japan
The Cancer Institute Hospital of JFCR, Koto-Ku, Tokyo, Japan
Seoul National University Hospital, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
National Taiwan University Hospital, Taipei, , Taiwan
Contact Details
Name: Global Clinical Leader
Affiliation: Daiichi Sankyo
Role: STUDY_DIRECTOR
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