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A phase 1 study of K-912, nonrandomized, open label, dose escalation study in Japanese patients with solid tumors.

A phase 1 study of K-912, nonrandomized, open label, dose escalation study in Japanese patients with solid tumors.

Status
Unknown
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080222174
Enrollment
30
Registered
2013-08-18
Start date
2013-08-18
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 : K-912 INN of investigational material : Therapeutic category code : 423 Antitumor antibiotics and preparations Dosage and Administration for Investigati

Sponsors

Kowa Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with histologically or cytologically diagnosis of solid tumor Patients with solid tumor which is resistant to standard anti-tumor therapies, or which no appropriate treatment is available Patients with adequate organ functions Patients with 0 to 1 of ECOG Performance Status (P.S.) score Patients with 12 weeks or more life expectancy and so on

Exclusion criteria

Exclusion criteria: Patients with the severe complication Patients with brain metastasis accompanying clinical symptoms Patients with hematopoietic tumor Patients with active infections in need of treatment for systemic and so on

Design outcomes

Primary

MeasureTime frame
Dose limiting toxicity (DLT) CTCAE ver.4.0

Secondary

MeasureTime frame
Pharmacokinetics and anti-tumor activity RECIST ver.1.1, Drug concentration measurement

Outcome results

None listed

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