Phase I Study of TAS-116 in Patients with Advanced Solid Tumors

A Phase I, Dose Escalation Study Evaluating the Safety, Tolerability and Pharmacokinetics of TAS-116 in Patients with Advanced Solid Tumors.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222394

Enrollment

150

Registered

2014-02-17

Start date

2014-03-31

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

Patients with advanced solid tumor

Interventions

investigational material(s) Generic name etc : TAS-116 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: - Signed, written informed consent. - Histologically or cytologically confirmed solid tumor. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.

Exclusion criteria

Exclusion criteria: - Investigational drug therapy within 21 days prior to enrollment. - Radiotherapy within 21 days prior to enrollment. - Received extensive prior radiotherapy on more than 30% of bone marrow. - Females who are pregnant or breastfeeding. - Serious complications.

Design outcomes

Primary

Measure	Time frame
safety Safety CTCAE (ver.4.03)	—

Secondary

Measure	Time frame
efficacy pharmacokinetics Pharmacokinetics, Efficacy RECIST (ver.1.1)	—

Countries

Japan

Outcome results

None listed

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