Efficacy and Safety of Patupilone in Patients With Advanced Solid Tumors in Japan

A Phase IA, Open-label, Dose Escalation Study of Patupilone Administered Intravenously Every 3 Weeks in Adult Patients With Advanced Solid Tumors

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00412789

Enrollment

Registered

2006-12-18

Start date

2006-08-31

Completion date

Unknown

Last updated

2010-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tumors

Keywords

Advanced solid tumor, Patupilone

Brief summary

The study will evaluate the safety and efficacy of Patupilone in adult patients with advanced solid tumors.

Interventions

DRUGPatupilone

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with a histologically/cytologically confirmed diagnosis of advanced solid tumors refractory to or unsuitable for standard therapy, or for whom no standard therapy exists * Patients with WHO Performance Status of 0-1 ( Karnofsky Performance Status of 80-100) * At least one measurable lesion

Exclusion criteria

* Patients with any peripheral neuropathy * Patients with unresolved diarrhea * Patients with severe and/or uncontrolled medical conditions or infections that require systemic therapy Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Dose-limiting Toxicity	18 months

Secondary

Measure	Time frame
Safety and tolerability of patupilone assessed by CTCAE	18 months
Pharmacokinetic profile of patupilone	18 months
Anti-tumor activity of patupilone according to the RECIST guidelines	18 months

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026