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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
History of Changes
  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:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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
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 May 16, 2013