Study In Patients With Kidney Cancer Treated With Sutent
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00873210
First received: March 30, 2009
Last updated: November 7, 2012
Last verified: November 2012
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Purpose
Objective of this study is to increase knowledge about safety, tolerability, quality of life and efficacy under conditions of routine use of sunitinib.
| Condition | Intervention |
|---|---|
|
Advanced or Metastatic Renal Cell Carcinoma Renal Cancer |
Drug: Sutent |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Non-Interventional Study In Patients With Advanced And/Or Metastatic Renal Cell Carcinoma (mRCC) Treated With Sutent |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Increased knowledge about safety, tolerability, quality of life and efficacy under conditions of routine use of sunitinib [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Dose modifications [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- Incidence of new diagnosed hypertension [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
- Incidence of new diagnosed hypothyroidism [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
- Safety of sunitinib malate in "real-life" setting [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
- Efficacy of sunitinib malate in "real-life" setting [ Time Frame: 36 months ] [ Designated as safety issue: No ]
| Enrollment: | 121 |
| Study Start Date: | May 2009 |
| Study Completion Date: | November 2011 |
| Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Patients treated with Sutent
125 consecutive patients in outpatient care with advanced or metastatic renal cell carcinoma, that are indicated for 1st or 2nd line anticancer therapy
|
Drug: Sutent
50 mg per day for 4 consecutive weeks, followed by 2 weeks treatment pause
Other Name: sunitinib malate
|
Detailed Description:
Consecutive patients with advanced or metastatic renal cell carcinoma, that are indicated for 1st or 2nd line anticancer therapy
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Patients with advanced or metastatic renal cell carcinoma, that are indicated for 1st or 2nd line anticancer therapy.
Criteria
Inclusion Criteria:
- Consecutive patients with advanced or metastatic renal cell carcinoma, that are indicated for 1st or 2nd line anticancer therapy
Exclusion Criteria:
- Hypersensitivity to sunitinib malate or to any of the excipients
- Any other contraindication to the use of sunitinib malate (based on decision of the treating physician).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00873210
Locations
| Slovakia | |
| Pfizer Investigational Site | |
| Banska Bystrica, Slovakia, 975 17 | |
| Pfizer Investigational Site | |
| Bojnice, Slovakia, 972 01 | |
| Pfizer Investigational Site | |
| Bratislava, Slovakia, 812 50 | |
| Pfizer Investigational Site | |
| Bratislava, Slovakia, 833 10 | |
| Pfizer Investigational Site | |
| Kosice, Slovakia, 043 91 | |
| Pfizer Investigational Site | |
| Michalovce, Slovakia, 071 01 | |
| Pfizer Investigational Site | |
| Nitra, Slovakia, 949 01 | |
| Pfizer Investigational Site | |
| Poprad, Slovakia, 058 01 | |
| Pfizer Investigational Site | |
| Presov, Slovakia, 081 81 | |
| Pfizer Investigational Site | |
| Ruzomberok, Slovakia, 034 26 | |
| Pfizer Investigational Site | |
| Trebisov, Slovakia, 075 01 | |
| Pfizer Investigational Site | |
| Trencin, Slovakia, 911 71 | |
| Pfizer Investigational Site | |
| Trnava, Slovakia, 917 75 | |
| Pfizer Investigational Site | |
| Zilina, Slovakia, 012 07 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00873210 History of Changes |
| Other Study ID Numbers: | A6181185 |
| Study First Received: | March 30, 2009 |
| Last Updated: | November 7, 2012 |
| Health Authority: | Slovakia: Ethics Commitee of the Bratislava Selgf-Governing Region |
Keywords provided by Pfizer:
|
renal cell carcinoma sunitinib malate |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Renal Cell Kidney Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases |
Urologic Diseases Sunitinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013