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


Phase 1
20 Years
N/A
Not Enrolling
Both
Tumors

Thank you

Trial Information

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

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose-limiting Toxicity

Outcome Time Frame:

18 months

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

CEPO906A1103

NCT ID:

NCT00412789

Start Date:

August 2006

Completion Date:

Related Keywords:

  • Tumors
  • Advanced solid tumor
  • Patupilone

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