A Phase I study of TSU-68 in patient with non-small cell lung cancer

A Phase I study of TSU-68 in combination with Carboplatin and Paclitaxel in patients with Advanced Non-Small Cell Lung Cancer

Status

Unknown

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221286

Enrollment

Registered

2010-10-26

Start date

2010-10-26

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

Non-small cell lung cancer

Interventions

investigational material(s) Generic name etc : TSU-68, Carboplatin, Paclitaxel INN of investigational material : orantinib, carboplatin, paclitaxel Therapeutic category code : 429 Other antitumor agen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients must be 20 years or more and 74 years or less with Performance Status of 0 to 1. 2)Life expectancy is 12 weeks or more. 3)Adequate oral intake. 4)Patients must have histologically confirmed stage IIIb/IV or recurrent NSCLC.

Exclusion criteria

Exclusion criteria: 1)Patients have colon disorder that is active inflammation. 2)Concurrent of other malignancy. 3)Patients who have been previously treated with investigational products within the past 4 weeks. 4)The subject has hypersensitivity reaction related to CBDCA, PTX or premedication.

Design outcomes

Primary

Measure	Time frame
Safety CTCAE Ver.3.0	—

Secondary

Measure	Time frame
Progression free survival, Response rate, Overall survival RECIST Guideline	—

Outcome results

None listed

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