TAS4464 Phase I study

A PHASE IA/IB, OPEN-LABEL, SAFETY, TOLERABILITY, PHARMACOKINETIC, AND EFFICACY STUDY OF TAS4464 IN PATIENTS WITH ADVANCED MALIGNANCIES

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223433

Enrollment

120

Registered

2017-01-13

Start date

2017-02-27

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

advanced malignancies

Interventions

investigational material(s) Generic name etc : TAS4464 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. Provided written informed consent for treatment. 2. Male or female, more than or equal to 20 years of age at enrollment. 3. Histologically or cytologically confirmed malignancies that is advanced or metastatic which no standard treatment remains.

Exclusion criteria

Exclusion criteria: 1. Serious illness or medical condition(s) 2. Known hypersensitivity to any drugs similar to TAS4464 in class or to inactive ingredients of TAS4464. 3. Pregnant or lactating females or females of child-bearing potential who have a positive pregnancy test within 7 days prior to the day on which the study drug is scheduled to be administered.

Design outcomes

Primary

Measure	Time frame
safety efficacy Safety, Efficacy NCI CTCAE v4.03 RECIST Version1.1 Revised Response Criteria for Malignant Lymphoma Response Criteria of Adult T-Cell Leukemia-Lymphoma IMWG Uniform Response Criteria for Multiple Myeloma	—

Secondary

Measure	Time frame
pharmacokinetics pharmacodynamics pharmacogenomics Pharmacokinetics, pharmacodynamics, pharmacogenomics	—

Countries

Japan

Outcome results

None listed

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