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Dose-Escalation and Safety Trial of YN968D1

NCT01497704 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2017-10-02

No results posted yet for this study

Summary

This protocol will be divided into two parts: Part 1 will evaluate the safety and pharmacokinetics of three doses of YN968D1 after a single administration followed by a 28-Day continuous course of therapy; Part 2 will evaluate the safety and preliminary efficacy in an open-label administration of YN968D1 at the MTD or a maximum of 750 mg. All subjects in Part 1 and Part 2 of this study will be permitted to continue therapy with only safety monitoring and bimonthly assessments for progression, if the product is well tolerated and the subject has stable disease or better. Up to 72 subjects will be enrolled in this clinical trial.

Conditions

  • Cancer Patients With Solid Tumors

Interventions

DRUG

YN968D1

Daily dosing of YN968D1 for treatment of solid tumors

Sponsors & Collaborators

  • Bukwang Pharmaceutical, Co., Ltd.

    collaborator INDUSTRY

  • Elevar Therapeutics

    lead INDUSTRY

Principal Investigators

  • Sunil Sharma, MD, FACP · Huntsman Cancer Institute

  • Yoon-Koo Kang, MD, PhD · Asan Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2015-02-28
Completion
2015-05-31

Countries

  • United States
  • South Korea

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 NCT01497704 on ClinicalTrials.gov