Dose-Escalation and Safety Trial of YN968D1

  • STATUS
    Recruiting
  • participants needed
    42
  • sponsor
    Bukwang Pharmaceutical, Co., Ltd.
Updated on 8 November 2020

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 up to 28-Days of continuous 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.

Description

Part 1 will include a sequential evaluation of 3 subjects per cohort; cohort 1 at a dose of 100 mg YN968D1, followed by a cohorts 2, 3 and 4 at doses of 250 mg, 500 mg and 750 mg respectively. Initially, each subject will receive one dose of YN968D1 followed by an observation period at least 7 days, during which single dose PK assessments and safety monitoring will be performed. If the initial dose is well tolerated, the subject will return on Day 8 and receive up to 28-Days of continuous YN968D1 oral administration daily. Each subject will subsequently be assessed for safety and disease progression on Day 35±2 and steady state pharmacokinetic sampling will be obtained. Patients may continue on therapy for an additional cycles up to 28-Days without dose interruption if the therapy is well tolerated. Efficacy assessments (biomarkers) and disease progression (RECIST imaging) will be assessed every two 28-Day cycles (±3 days). The subjects will be assessed for safety for at least 28-Days after the last dose of YN968D1. For Part 1 of this study, a Dose Limiting Toxicity (DLT) event is defined as any of the following events that are assessed by the Investigator as probably or possibly related to YN968D1 and occur during or after the initial dose on Day 1 through Day 35 (±3) of the first cycle of therapy. DLT is defined as: - CTCAE Grade 4 event - Grade 3 febrile neutropenia (<1,000 neutrophils/mL) - Grade 3 hematologic toxicity with duration > 7 days - Grade 3 non-hematologic toxicity (except for nausea, vomiting, diarrhea that continues despite optimal medical management) If a DLT is experienced in any cohort, the cohort will be expanded to 6 subjects. If two (2) DLTs are experienced in any cohort, the study will be paused until the safety events are evaluated and discussed with the FDA to determine if the trial may continue. Part 2 of this study will include up to 30 subjects. Each subject will receive a 750 mg dose or the maximum tolerated dose of YN968D1 from part 1 of the study for up to 28-Days continuous cycles of therapy. If a subject experiences an intolerable side effect a dose reduction or a dose interruption for up to Days is allowed at the discretion of the investigator. Subjects will be evaluated for RECIST (version 1.1) response at the end of the second cycle of therapy on Day 56±3 of the Part 2 study. Safety reporting will be continued for up to 28-Days from the last dose of study medication. All subjects in Part 1 and 2 of this trial will be eligible to continue therapy provided they have a least stable disease or better and are, in the opinion of the investigator, adequately tolerating treatment with YN968D1.

Details
Condition Cancer Patients With Solid Tumors
Treatment YN968D1
Clinical Study IdentifierNCT01726101
SponsorBukwang Pharmaceutical, Co., Ltd.
Last Modified on8 November 2020

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