Evaluate the Effects of Patupilone on the Pharmacokinetics of Midazolam and Omeprazole in Patients With Advanced Malignancies (Extension)
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ClinicalTrials.gov Identifier: NCT00442741 |
Recruitment Status :
Withdrawn
(pts. will be captured in core)
First Posted : March 2, 2007
Last Update Posted : April 25, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Solid Tumors | Drug: Patupilone Drug: Patupilone + Omeprazole | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official 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) |
Study Start Date : | July 2007 |
Actual Primary Completion Date : | July 2007 |

Arm | Intervention/treatment |
---|---|
Experimental: Patupilone + Midazolam |
Drug: Patupilone |
Experimental: Patupilone + Omeprazole |
Drug: Patupilone + Omeprazole |
- To evaluate the safety, tolerability and potential activity of patupilone once every 21 days in patients that completed the core study
- Assessment of objective response and tumor evaluation will be based on the response evaluation criteria in solid tumors (RECIST)

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00442741
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00442741 |
Other Study ID Numbers: |
CEPO906A2123E1 |
First Posted: | March 2, 2007 Key Record Dates |
Last Update Posted: | April 25, 2012 |
Last Verified: | April 2012 |
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