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An Open Label Phase I Study to Evaluate the Effects of Patupilone on the Pharmacokinetics of Midazolam and Omeprazole in Patients With Advanced Malignancies (Extension)


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Tumors

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Trial Information

An Open Label Phase I Study to Evaluate the Effects of Patupilone on the Pharmacokinetics of Midazolam and Omeprazole in Patients With Advanced Malignancies (Extension)

Inclusion Criteria


Inclusion criteria:

- Male or female patients 18 years or older

- Histologically documented advanced solid tumor, who have failed standard systemic
therapy, or for whom standard systemic therapy does not exist

- Completed the Core study

- Completed all sampling in the core and not dose reduced Patients with adequate
hematologic parameters

Exclusion criteria:

- Female patients who are pregnant or breast-feeding.

- Patients with a severe and/or uncontrolled medical disease

- Patients with a known diagnosis of human immunodeficiency virus (HIV) infection

- Patients having received an investigational agent within 30 days prior to study entry

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:

To evaluate the safety, tolerability and potential activity of patupilone once every 21 days in patients that completed the core study

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CEPO906A2123E1

NCT ID:

NCT00442741

Start Date:

July 2007

Completion Date:

Related Keywords:

  • Solid Tumors
  • Cancer
  • EPO906
  • Patupilone

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