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

Novartis

Status and phase: Completed; Phase 1

Conditions: Tumors

Treatments: Drug: Patupilone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00412789

CEPO906A1103

Details and patient eligibility

About

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

Enrollment: 15 patients

Sex: All

Ages: 20+ years old

Volunteers: No 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/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

EPO906

Experimental group

Treatment:

Drug: Patupilone