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Study of DS-1123a in Advanced Solid Tumours

NCT ID: NCT02690337

Last Updated: 2018-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-11-30

Brief Summary

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This is an open-label study to evaluate the safety, tolerability, and pharmacokinetics of DS-1123a in Japanese subjects with advanced solid tumors.

Detailed Description

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Conditions

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Advanced Solid Malignant Tumors

Keywords

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Advanced solid malignant tumors phase 1 oncology refractory no standard treatment

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DS-1123

This study will follow a modified Continual Reassessment Method (mCRM) + Escalation with Overdose Control (EWOC),design with a starting intravenous (IV) dose of 0.1 mg/kg.

Group Type EXPERIMENTAL

DS-1123

Intervention Type DRUG

starting intravenous (IV) dose of 0.1 mg/kg.

Interventions

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DS-1123

starting intravenous (IV) dose of 0.1 mg/kg.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Advanced solid tumor that is refractory to standard treatment, or for which no standard treatment is available.
* Eastern Cooperative Oncology Group performance status (PS) of 0 or 1.

Exclusion Criteria

* Have any of the following concomitant disease or had the history of having following disease within 6 months before enrollment:

• Cardiac failure (NYHA ≥ ClassIII), myocardial infarction, cerebral infarction, unstable angina, arrhythmia requiring treatment, coronary-artery/peripheral artery bypass surgery, cerebrovascular disease, pulmonary thromboembolism, deep-vein thrombosis or clinically severe thromboembolic event, or clinically severe pulmonary disease (eg, interstitial pneumonia, pulmonary fibrosis, radiation pneumonia, drug induced pneumonia),
* Severe or uncontrolled concomitant disease.
* Clinically active brain metastases defined as symptomatic or requiring treatment.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daiichi Sankyo Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Leader

Role: STUDY_DIRECTOR

Daiichi Sankyo

Locations

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Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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DS1123-A-J101

Identifier Type: -

Identifier Source: org_study_id