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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00412789
First received: December 15, 2006
Last updated: May 28, 2010
Last verified: May 2010
  Purpose

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


Condition Intervention Phase
Tumors
Drug: Patupilone
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase IA, Open-label, Dose Escalation Study of Patupilone Administered Intravenously Every 3 Weeks in Adult Patients With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Dose-limiting Toxicity [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety and tolerability of patupilone assessed by CTCAE [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Pharmacokinetic profile of patupilone [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Anti-tumor activity of patupilone according to the RECIST guidelines [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: August 2006
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EPO906 Drug: Patupilone
Other Name: EPO906

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00412789

Locations
Japan
Novartis Investigative Site
Tokyo, Japan
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00412789     History of Changes
Other Study ID Numbers: CEPO906A1103
Study First Received: December 15, 2006
Last Updated: May 28, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Novartis:
Advanced solid tumor
Patupilone

Additional relevant MeSH terms:
Epothilone B
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2014