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Phase II trial of YHI-1003

Phase II trial of YHI-1003 monotherapy in patients with advanced or relapsed gynecologic cancer

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080222238
Enrollment
96
Registered
2013-09-27
Start date
2013-09-27
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 or relapsed gynecologic cancer (ovarian, endometric or cervical cancer)

Interventions

Sponsors

Yakult Honsha Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: (1)Patients with a histologically-diagnosed ovarian , endometric or cervical cancer (2)Patients with a history of treatment with platinum-based chemotherary (3)Patients who have agreed with the investigation of biomarkers (4)Patients who can be treated with oral medications (5)Patients with at least one measurable disease

Exclusion criteria

Exclusion criteria: (1)Patients with a history of treatment with PI3K, AKT or mTOR inhibitor (2)Patients with uncontrolled intercurrent illness (3)Patients with brain metastases or suspected brain metastases

Design outcomes

Primary

MeasureTime frame
Disease Control Rate RECIST ver1.1

Secondary

MeasureTime frame
efficacy,safety and biomarker RECIST ver1.1, CTCAE v.4.0

Outcome results

None listed

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