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

Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00412789
• Other study ID #: CEPO906A1103
• Status: Completed
• Phase: Phase 1
• First received: December 15, 2006
• Last updated: May 28, 2010
• Start date: August 2006

Study information

• Verified date: May 2010
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tumors

Intervention

Drug:
• Patupilone

Locations

Country	Name	City	State
Japan	Novartis Investigative Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-limiting Toxicity		18 months	Yes
Secondary	Safety and tolerability of patupilone assessed by CTCAE		18 months	No
Secondary	Pharmacokinetic profile of patupilone		18 months	No
Secondary	Anti-tumor activity of patupilone according to the RECIST guidelines		18 months	No