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

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. Identifier: NCT00412789
Recruitment Status : Completed
First Posted : December 18, 2006
Last Update Posted : May 31, 2010
Information provided by:

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

Condition or disease Intervention/treatment Phase
Tumors Drug: Patupilone Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
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
Study Start Date : August 2006
Actual Primary Completion Date : January 2008

Arm Intervention/treatment
Experimental: EPO906 Drug: Patupilone
Other Name: EPO906

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

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

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

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

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 identifier (NCT number): NCT00412789

Novartis Investigative Site
Tokyo, Japan
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: External Affairs, Novartis Pharmaceuticals Identifier: NCT00412789     History of Changes
Other Study ID Numbers: CEPO906A1103
First Posted: December 18, 2006    Key Record Dates
Last Update Posted: May 31, 2010
Last Verified: May 2010

Keywords provided by Novartis:
Advanced solid tumor

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