SU011248 Versus Interferon-Alfa As First-Line Systemic Therapy For Patients With Metastatic Renal Cell Carcinoma
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ClinicalTrials.gov Identifier: NCT00083889 |
Recruitment Status :
Completed
First Posted : June 4, 2004
Results First Posted : December 10, 2009
Last Update Posted : January 26, 2010
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Sponsor:
Pfizer
Information provided by:
Pfizer
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Carcinoma, Renal Cell |
Interventions |
Drug: Interferon-alfa Drug: SU011248 |
Enrollment | 750 |
Participant Flow
Recruitment Details | A total of 101 medical centers took part in the study between 10 August 2004 and 19 September 2008. |
Pre-assignment Details | Subjects were to be followed until survival data was mature (median duration of follow-up: 123 weeks). |
Arm/Group Title | SU011248 | IFN-α |
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Arm/Group Description | 50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered. | Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity. |
Period Title: Overall Study | ||
Started | 375 | 375 |
Received Treatment | 375 | 360 [1] |
Completed | 0 | 0 [2] |
Not Completed | 375 | 375 |
Reason Not Completed | ||
Adverse Event | 76 | 86 |
Protocol Violation | 2 | 2 |
Withdrawal by Subject | 22 | 24 |
Lack of Efficacy | 240 | 219 |
Decision of sponsor | 32 | 4 |
Randomized: did not take study drug | 0 | 15 |
Completed on marketed sunitinub | 3 | 0 |
Crossover to SU011248 | 0 | 25 |
[1]
15 subjects randomized to IFN-α discontinued before receiving their first dose of study medication.
[2]
Discontinuation crossover subjects: AEs 5,consent withdrawn 2, lack efficacy 13, sponsor decision 5.
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Baseline Characteristics
Arm/Group Title | SU011248 | IFN-α | Total | |
---|---|---|---|---|
Arm/Group Description | 50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered. | Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity. | Total of all reporting groups | |
Overall Number of Baseline Participants | 375 | 375 | 750 | |
Baseline Analysis Population Description |
[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 375 participants | 375 participants | 750 participants | |
<=18 years |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Between 18 and 65 years |
223 59.5%
|
252 67.2%
|
475 63.3%
|
|
>=65 years |
152 40.5%
|
123 32.8%
|
275 36.7%
|
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 375 participants | 375 participants | 750 participants | |
Female |
108 28.8%
|
106 28.3%
|
214 28.5%
|
|
Male |
267 71.2%
|
269 71.7%
|
536 71.5%
|
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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.
Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: | Pfizer ClinicalTrials.gov Call Center |
Organization: | Pfizer, Inc. |
Phone: | 1-800-718-1021 |
EMail: | ClinicalTrials.govCallCenter@pfizer.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer Inc |
ClinicalTrials.gov Identifier: | NCT00083889 |
Obsolete Identifiers: | NCT00098657 |
Other Study ID Numbers: |
A6181034 |
First Submitted: | June 3, 2004 |
First Posted: | June 4, 2004 |
Results First Submitted: | September 16, 2009 |
Results First Posted: | December 10, 2009 |
Last Update Posted: | January 26, 2010 |