Phase I/II study of NK012

A Phase I/II study of NK012 in patients with multiple myeloma

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221611

Enrollment

Registered

2011-10-07

Start date

2011-10-07

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple myeloma

Interventions

investigational material(s) Generic name etc : NK012 INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material :

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
(PhaseI part)Safety, pharmacokinetics, QTc interval, efficacy (PhaseII part)Efficacy	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026