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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00412789
First Posted: December 18, 2006
Last Update Posted: May 31, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Novartis
  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
Intervention Model: Single Group Assignment
Masking: None (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

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Dose-limiting Toxicity [ Time Frame: 18 months ]

Secondary Outcome Measures:
  • Safety and tolerability of patupilone assessed by CTCAE [ Time Frame: 18 months ]
  • Pharmacokinetic profile of patupilone [ Time Frame: 18 months ]
  • Anti-tumor activity of patupilone according to the RECIST guidelines [ Time Frame: 18 months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00412789


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

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00412789     History of Changes
Other Study ID Numbers: CEPO906A1103
First Submitted: December 15, 2006
First Posted: December 18, 2006
Last Update Posted: May 31, 2010
Last Verified: May 2010

Keywords provided by Novartis:
Advanced solid tumor
Patupilone

Additional relevant MeSH terms:
Epothilone B
Epothilones
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action