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

NCT03383692 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-12-11

Study results available
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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).

Conditions

  • Neoplasm Metastasis

Interventions

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

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Daiichi Sankyo Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Global Clinical Leader · Daiichi Sankyo

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-12
Primary Completion
2018-09-26
Completion
2023-09-11

Countries

  • Japan
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03383692 on ClinicalTrials.gov