Nexavar Dosing in Renal Cancer Patients in "Real-life" Setting (NEXST)
This study is currently recruiting participants.
Verified May 2013 by Bayer
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01557127
First received: March 16, 2012
Last updated: May 10, 2013
Last verified: May 2013
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Purpose
This study is a registry of renal cancer patients treated with Nexavar. It aims to evaluate the actual dosing of Nexavar in "real-life" setting vs. the prescribed dose.
| Condition | Intervention |
|---|---|
|
Carcinoma, Renal Cell |
Drug: Sorafenib (Nexavar, BAY43-9006) |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Nexavar Dose Evaluation Study in Patients With Advanced Renal Cell Carcinoma |
Resource links provided by NLM:
Further study details as provided by Bayer:
Primary Outcome Measures:
- Percentage of patients in whom the actual dose of sorafenib equaled the planned dose [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall tolerability of treatment as measured by rate of adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 350 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Group 1 |
Drug: Sorafenib (Nexavar, BAY43-9006)
Patients scheduled for treatment with sorafenib given in regular daily dose i.e. 800mg (400mg bid)
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Adult patients with renal cell carcinoma scheduled to treatment with sorafenib, following therapy failure with IFN/IL-2
Criteria
Inclusion Criteria:
- Age >/= 18 years
- Diagnosis of renal cell carcinoma
- Failure of prior therapy with interferon-alfa (IFN) or interleukine-2 (IL-2) or disqulified from therapy with IFN/IL-2
- Patients in whom the oncologist has decide to start therapy with sorafenib.
Exclusion Criteria:
- Synonymous with contraindications to Nexavar.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01557127
Contacts
| Contact: Bayer Clinical Trials Contact | clinical-trials-contact@bayerhealthcare.com |
Locations
| Poland | |
| Recruiting | |
| Many Locations, Poland | |
Sponsors and Collaborators
Bayer
Investigators
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Medical Director, Bayer Sp. z o.o., Al. Jerozolimskie 158, 02-326 Warsaw, Poland |
| ClinicalTrials.gov Identifier: | NCT01557127 History of Changes |
| Other Study ID Numbers: | 16268 |
| Study First Received: | March 16, 2012 |
| Last Updated: | May 10, 2013 |
| Health Authority: | Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products |
Keywords provided by Bayer:
|
Renal cell carcinoma, Sorafenib Dosing |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Renal Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site |
Kidney Diseases Urologic Diseases Sorafenib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013