Non-Interventional Study (NIS) In Patients With Advanced And/Or Metastatic Renal Cell Carcinoma (mRCC) Treated With SUTENT®

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00684645
First received: May 22, 2008
Last updated: July 17, 2012
Last verified: July 2012
Results First Received: April 18, 2012  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Metastatic Renal Cell Carcinoma
Intervention: Drug: SUTENT

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Sunitinib The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.

Participant Flow:   Overall Study
    Sunitinib  
STARTED     186  
COMPLETED     72  
NOT COMPLETED     114  
Death                 2  
Progressive disease                 67  
Adverse Event                 27  
Lost to Follow-up                 3  
Not specified                 15  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Sunitinib The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.

Baseline Measures
    Sunitinib  
Number of Participants  
[units: participants]
  186  
Age, Customized  
[units: participants]
 
18 to 44 years     10  
45 to 64 years     99  
65 years or more     77  
Gender  
[units: participants]
 
Female     58  
Male     128  
Involvement of Regional Lymph Nodes [1]
[units: participants]
 
Iliac     31  
Paraaortal     25  
Paracaval     6  
Previous Anti-Tumor Therapy [1]
[units: participants]
 
Prior Radiotherapy     152  
Prior Chemotherapy     173  
Prior Hormonal Therapy     180  
Prior Immunotherapy     35  
Prior Cancer Surgeries     8  
Eastern Cooperative Oncology Group (ECOG) Performance Status [2]
[units: percentage¬†of¬†participants]
 
ECOG Performance Status 0     23  
ECOG Performance Status 1     72  
ECOG Performance Status 2     5  
ECOG Performance Status 3     0  
ECOG Performance Status 4     0  
ECOG Performance Status 5     0  
Frequency of Involved Disease Sites [1]
[units: participants]
 
Adrenal     5  
Bone     32  
Chest wall     1  
Kidney     26  
Liver     20  
Lung     88  
Lymph node     7  
Lymph node - Mediastinum     13  
Lymph node - Other     4  
Lymph node - Retroperitoneal     12  
Lymph node - Supraclavicular     2  
Lymph node - Regional     2  
Mediastinum     3  
Other     13  
Pancreas     4  
Pelvis     1  
Peritoneum     7  
Pleura     1  
Skin     1  
Spleen     1  
Prevalence of hypothyroidism [3]
[units: participants]
 
Hypothyroidism present     15  
Hypothyroidism absent     171  
Prevalence of Hypertension [4]
[units: participants]
 
Hypertension present     119  
Hypertension absent     67  
[1] The sum of participants may not be equal to the number of participants beginning the study. A participant may be included in more than one category, or a participant may not be included in any category.
[2] ECOG criteria: 0: Fully active. 1: Ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of all selfcare. 3: Capable of limited selfcare, confined to bed or chair more than 50% of waking hours. 4: Completely disabled, no selfcare, totally confined to bed or chair. 5: Dead.
[3] At baseline, participants were considered hypothyroid if the investigator indicated they had hypothyroidism (yes/no) on the case report form (CRF). At subsequent visits, thyroid-stimulating hormone (TSH) and free thyroxine (FT4) levels were measured and hypothyroidism was defined as a TSH level greater than (>)5.0 milli-International Units per liter (mIU/L) at that visit.
[4] Hypertension was defined as blood pressure >140/90 millimeters of Mercury (mm Hg). At baseline, presence/absence of hypertension was recorded. If either the presence/absence of hypertension question or the blood pressure at Baseline indicated that the participant currently had hypertension, then the participant was considered to have hypertension at baseline. At subsequent visits, hypertension status was determined in terms of the blood pressure recorded at that visit.



  Outcome Measures
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1.  Primary:   Percentage of Participants With Objective Response   [ Time Frame: 12 months ]

2.  Primary:   Progression-free Survival (PFS)   [ Time Frame: Baseline to measured progressive disease (up to 12 months) ]

3.  Primary:   Overall Survival (OS)   [ Time Frame: Baseline to date of death (up to 12 months) ]

4.  Primary:   Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Week 6   [ Time Frame: Week 6 ]

5.  Primary:   Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 3   [ Time Frame: Month 3 ]

6.  Primary:   Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 6   [ Time Frame: Month 6 ]

7.  Primary:   Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 9   [ Time Frame: Month 9 ]

8.  Primary:   Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 12   [ Time Frame: Month 12 ]

9.  Primary:   Correlation Between Sunitinib-induced Hypertension and Tumor Response to Treatment (PFS)   [ Time Frame: Baseline to date of first documentation of response to treatment (up to 12 months) ]

10.  Primary:   Correlation Between Sunitinib-induced Hypertension and Tumor Response to Treatment (OS)   [ Time Frame: Baseline to date of death (up to 12 months) ]

11.  Primary:   Percentage of Participants With Hypothyroidism   [ Time Frame: Baseline, Months 3, 6, 9, 12 ]

12.  Primary:   Percentage of Participants With Hypertension   [ Time Frame: Baseline, Week 6, Months 3, 6, 9, 12 ]

13.  Other Pre-specified:   Summary of Adverse Events for Participants Who Required Dose Modification   [ Time Frame: Baseline up to 12 months ]

14.  Other Pre-specified:   Percentage of Participants With Treatment-emergent Hypertension, by Common Terminology Criteria for Adverse Events (CTCAE) Grade   [ Time Frame: Baseline up to 12 months ]

15.  Other Pre-specified:   Percentage of Participants Responding to Treatment   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00684645     History of Changes
Other Study ID Numbers: A6181171
Study First Received: May 22, 2008
Results First Received: April 18, 2012
Last Updated: July 17, 2012
Health Authority: Czech Republic: State Institute for Drug Control