Phase I/II study of NK012
Phase 1
- Conditions
- Multiple myeloma
- Registration Number
- JPRN-jRCT2080221611
- Lead Sponsor
- ippon Kayaku Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
1.Symptomatic disease thought to require therapy and received therapy at least 2 regimens
2.ECOG performance status (P.S.) score of 0-2(include P.S.3 with osteolytic disease)
3.Patients who don't have abnormal ECG with therapy
4.Patients age 20 to 79 years(inclusive)at time of informed consent
Exclusion Criteria
1.By pharmacogenetic testing, patients who are homozygous for UGT1A1*28 or UGT1A1*6, or those who are simultaneously heterozygous for UGT1A1*28 and UGT1A*6
2.Patients who received irinotecan hydrochloride or nogitecan hydrochloride or drugs (include investigational agent) which have same mechanisms of action (type I DNA topoisomerase inhibition)
3.Patients who are plasma cell leukemia
4.Patients who have active infection
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method (PhaseI part)Safety, pharmacokinetics, QTc interval, efficacy<br>(PhaseII part)Efficacy
- Secondary Outcome Measures
Name Time Method