|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00442741 |
|
Date of registration:
|
01/03/2007 |
|
Primary sponsor: |
|
|
Public title:
|
Evaluate the Effects of Patupilone on the Pharmacokinetics of Midazolam and Omeprazole in Patients With Advanced Malignancies (Extension)
|
|
Scientific title:
|
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) |
|
Date of first enrolment:
|
July 2007 |
|
Target sample size:
|
0 |
|
Recruitment status: |
Withdrawn |
|
URL:
|
http://clinicaltrials.gov/show/NCT00442741 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Novartis Pharmaceuticals |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Novartis Pharmaceuticals |
| | |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Solid Tumors
|
|
Intervention(s)
|
|
Drug: Patupilone
|
|
Drug: Patupilone + Omeprazole
|
|
Primary Outcome(s)
|
|
To evaluate the safety, tolerability and potential activity of patupilone once every 21 days in patients that completed the core study
|
|
Secondary Outcome(s)
|
|
Assessment of objective response and tumor evaluation will be based on the response evaluation criteria in solid tumors (RECIST)
|
|
Secondary ID(s)
|
|
CEPO906A2123E1
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|