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Open Label Study of DS-5573a

NCT02192567 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2017-03-03

No results posted yet for this study

Summary

This is an open-label, sequential dose escalation and expansion study to evaluate the safety, and pharmacokinetics of DS-5573a in Japanese patients with advanced solid malignant tumors.

Conditions

  • Advanced Solid Malignant Tumors

Interventions

DRUG

DS-5573a

Step 1 of this study will use a starting intravenous (IV) dose of 0.1 mg/kg. Eight dose levels are planned, level 1: 0.1 mg/kg, level 1.5: 0.1 mg/kg, 0.3 mg/kg, level 2: 0.3 mg/kg, level 3: 1 mg/kg, level 4: 3 mg/kg, level 5: 10 mg/kg, level 6: 20 mg/kg, level 7: 30 mg/kg. Step 2: 30 subjects will use the dose determined in Step 1.

Sponsors & Collaborators

  • Daiichi Sankyo Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Kenji Tamura, MD · National Cancer Center Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • Japan

Study Locations

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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 NCT02192567 on ClinicalTrials.gov