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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


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

Thank you

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

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

- Life expectancy of 3 months or more

- Patients with adequate hematologic parameters

Exclusion criteria:

- Hypersensitivity to midazolam or omeprazole or related compounds

- 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: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the effects of patupilone on the pharmacokinetics of midazolam in patients with advanced malignancies.

Outcome Time Frame:

Day 1 (0.5h, 1h, 1.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h), Day 29 (0.5h, 1h, 1.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h)

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmeceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CEPO906A2123

NCT ID:

NCT00420615

Start Date:

December 2006

Completion Date:

Related Keywords:

  • Solid Tumors
  • Cancer
  • EPO906
  • Patupilone

Name

Location

The University of Texas MD Anderson Cancer CenterHouston, Texas  77030-4009