A Study of Patupilone in Patients With Advanced Solid Tumors and Varying Degrees of Hepatic Function
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00421044
First received: January 9, 2007
Last updated: January 9, 2012
Last verified: January 2012
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Purpose
Patients who participated in the core EPO2121 study and did not clinically progress may participate in this extension protocol to further evaluate the safety, tolerability, and efficacy of patupilone.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Malignancies Tumors |
Drug: Patupilone/EPO906 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-label, Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Patupilone in Patients With Advanced Solid Tumors and Varying Degrees of Hepatic Function |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Safety and tolerability in patients with hepatic impairment will be assessed by adverse events (AEs), serious adverse events (SAEs) and out of range lab values [ Time Frame: at completion of the study ] [ Designated as safety issue: Yes ]
- To evaluate the preliminary anti-tumor activity which will be assessed by radiological scans every 6 weeks [ Time Frame: at completion of the study ] [ Designated as safety issue: Yes ]
| Enrollment: | 14 |
| Study Start Date: | May 2006 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm A (Normal liver function) | Drug: Patupilone/EPO906 |
| Experimental: Arm B (Mild liver dysfunction) | Drug: Patupilone/EPO906 |
| Experimental: Arm C (Moderate liver dysfunction) | Drug: Patupilone/EPO906 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Completion of the core study is required for participation in the extension.
- 18 years of age or older
- World Health Organization (WHO) Performance Status score of: 0 - you are fully active and more or less as you were before your illness; 1 - you cannot carry out heavy physical work, but can do anything else; or 2 - you are up and about more than half the day, you can look after yourself, but are not well enough to work.
- Life expectancy of 3 months or more
- Patients with measurable or evaluable disease who have histologically documented advanced solid tumor and who have progressed after systemic therapy or for whom standard systemic therapy does not exist
Exclusion Criteria:
- Severe and/or uncontrolled medical disease
- Known diagnosis of human immunodeficiency virus (HIV) infection
- Presence of any other active or suspected acute or chronic uncontrolled infection
- Severe cardiac insufficiency, with uncontrolled and/or unstable cardiac or coronary artery disease
- History of another malignancy within 5 years prior to study entry, except for curatively treated non-melanotic skin cancer or cervical cancer in situ
Other protocol-defined inclusion/exclusion criteria may apply.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00421044
Locations
| United States, California | |
| University of California San Diego/Moores Cancer Center | |
| La Jolla, California, United States, 92093-0987 | |
| United States, Texas | |
| Institute for Drug Development Cancer Therapy & Research Center/The University of Texas Health Science Center | |
| San Antonio, Texas, United States, 78229 | |
| South Texas Accelerated Research Therapeutics | |
| San Antonio, Texas, United States, 78229 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmeceuticals |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT00421044 History of Changes |
| Obsolete Identifiers: | NCT00478920 |
| Other Study ID Numbers: | CEPO906A2121E1 |
| Study First Received: | January 9, 2007 |
| Last Updated: | January 9, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Novartis:
|
EPO Patupilone Solid Tumors |
Additional relevant MeSH terms:
|
Neoplasms Epothilone B Tubulin Modulators Antimitotic Agents Mitosis Modulators |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013