NCT03383692

Study of DS-8201a for Participants With Advanced Solid Malignant Tumors

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Daiichi Sankyo Co., Ltd. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neoplasm Metastasis

Interventions

Type	Name	Description
DRUG	DS-8201a	DS-8201a is provided as a sterile lyophilized powder of DS-8201a in a glass vial, which will be dissolved and administered as an intravenous (IV) solution
DRUG	Ritonavir	Ritonavir is a OATP1B inhibitor; an antiretroviral tablet for oral administration
DRUG	Itraconazole	Itraconazole is a CYP3A inhibitor; an antifungal tablet for oral administration

Timeline

• Start date: 2018-01-12
• Primary completion: 2018-09-26
• Completion: 2023-09-11
• First posted: 2017-12-26
• Last updated: 2023-12-11
• Results posted: 2021-06-14

Locations

10 sites across 3 countries: Japan, South Korea, Taiwan