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OpenTrials
Completed

NCT Number: NCT00412789

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

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

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Key information

Conditions

Tumors Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patupilone

Drug

Other names: EPO906

Primary outcomes

  1. Dose-limiting Toxicity

    Time frame: 18 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
First posted
Dec 18, 2006
Registry last updated
May 31, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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