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A Phase I Study of Subutinib Maleate Capsules on Toleration and Pharmacokinetics

NCT01806376 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2013-03-08

No results posted yet for this study

Summary

1. purpose: to explore the maximum tolerated dose, dose-limiting toxicity of oral Subutinib Maleate capsules and rational dosage regimen for phase Ⅱ study
2. Experimental Design： A phase Ⅰ study of single-center
3. Test drug: Subutinib Maleate capsules
4. Sample size≥20

Conditions

Interventions

DRUG

Subutinib Maleate capsules

Dose escalation will be dependent on any dose limiting toxicities

Sponsors & Collaborators

  • Fudan University

    collaborator OTHER

  • Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Li jin, doctor · Fudan University

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • China

Study Locations

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Entities

Diseases

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 NCT01806376 on ClinicalTrials.gov