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Phase I Study of TAS-115 in Patients with Advanced Solid Tumors

A Phase 1, Dose Escalation Study Evaluating the Safety, Tolerability and Pharmacokinetics of TAS-115 in Patients with Advanced Solid Tumors.

Status
Unknown
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080221605
Enrollment
85
Registered
2011-10-05
Start date
2011-10-05
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-115 INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material

Sponsors

Taiho Pharmaceutical Co., Ltd.
Lead Sponsor

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 2.

Exclusion criteria

Exclusion criteria: - Investigational drug therapy within 28 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

MeasureTime frame
Safety CTCAE (ver.4.03)

Secondary

MeasureTime frame
Pharmacokinetics, Efficacy RECIST (ver.1.1)

Outcome results

None listed

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