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Phase I/II study of YHI-1001 in combination with Docetaxel in patients with advanced, metastatic or recurrent non-small cell lung cancer who have received platinum-based chemotherapy

Phase I/II study of YHI-1001 in combination with Docetaxel in patients with advanced, metastatic or recurrent non-small cell lung cancer who have received platinum-based chemotherapy

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080222077
Enrollment
118
Registered
2013-05-10
Start date
2013-05-10
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 non-small cell lung cancer who have received platinum-based chemotherapy

Interventions

investigational material(s) Generic name etc : YHI-1001+Docetaxel INN of investigational material : Resminostat+Docetaxel Therapeutic category code : 429 Other antitumor agents Dosage and Administrati

Sponsors

Yakult Honsha Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1)Patients with histologically or cytologically confirmed non-small cell lung cancer (2)Patients who have received platinum-based chemotherapy (3)Patients with ECOG PS of 0-1 (4)Patients who are able to take YHI-1001 orally and do not have GI dysfunction impacting on abosorption of YHI-1001

Exclusion criteria

Exclusion criteria: (1)Patients who have taken HDAC inhibitors or Docetaxel (2)Patients with uncontrolled intercurrent illness

Design outcomes

Primary

MeasureTime frame
PI:Safety PII:Efficacy

Secondary

MeasureTime frame
PI:PK PII:Safety

Outcome results

None listed

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