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Phase 1 Study of KRN951

An Open-label, Non-randomised Dose Escalation Study of KRN951 Administered Orally to Patients with Solid Tumors

Status
Unknown
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080220823
Enrollment
12
Registered
2009-08-20
Start date
2009-08-20
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

Solid tumors

Interventions

investigational material(s) Generic name etc : KRN951 INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material :

Sponsors

Kyowa Hakko Kirin Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Signed written informed consent Solid tumors to be unresponsive to, or untreatable by standard therapies Three-month or more life expectancy Eastern Cooperative Oncology Group Performance Status score of 0, 1 or 2

Exclusion criteria

Exclusion criteria: Hematologic abnormality Myocardial infarction or clinically symptomatic left ventricular failure Active hypertension or controllable hypertension more than 3 antihypertensive medications Symptomatic CNS metastasis Unhealed wounds Active infections Hepatic or renal functional disorder Any of the HBs antigen, HCV antibody and HIV antibody positivity Prior use of any chemotherapy, radiotherapy, immunotherapy or surgery within four weeks previous to first dose of study drug Pregnant or lactating women Women of childbearing potential and fertile men, unless willing to use adequate contraceptive protection

Design outcomes

Primary

MeasureTime frame
To define the maximum tolerated dose (MTD) of KRN951

Secondary

MeasureTime frame
Pharmacokinetics and anti-tumor activity

Outcome results

None listed

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