Sunitinib Malate Schedule 4/2 vs. Sunitinib Malate Continuous Dosing As First-Line Therapy For Metastatic Renal Cell Cancer (RCC)
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| ClinicalTrials.gov Identifier: NCT00267748 |
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Recruitment Status :
Completed
First Posted : December 21, 2005
Results First Posted : September 5, 2011
Last Update Posted : September 5, 2011
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Sponsor:
Pfizer
Information provided by:
Pfizer
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
| Condition |
Carcinoma, Renal Cell |
| Interventions |
Drug: Sunitinib Malate Continuous Daily Dosing Drug: Sunitinib Malate Schedule 4/2 |
| Enrollment | 317 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details |
| Arm/Group Title | Sunitinib 37.5 mg + Interferon Alpha-2b | Sunitinib 50 mg (Schedule 4/2) | Sunitinib 37.5 mg |
|---|---|---|---|
 Arm/Group Description |
Sunitinib 37.5 mg or 50 mg self administered orally once daily in the evening for 4 consecutive weeks followed by 2 weeks off (Schedule 4/2) to comprise a complete 6-weeks cycle. Concomitant Interferon (IFN) alpha-2b self-administered at a dose of 3 million units (MU) or 6 MU or 9MU subcutaneously (s.c.) 3 times weekly on non-consecutive days for up to 1 year (9 cycles) of treatment or early withdrawal. | Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle. | Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning. |
| Period Title: Non-randomized Period | |||
| Started | 25 | 0 | 0 |
| Completed | 2 | 0 | 0 |
| Not Completed | 23 | 0 | 0 |
| Reason Not Completed | |||
| Progressive disease | 10 | 0 | 0 |
| Adverse Event | 8 | 0 | 0 |
| Death | 1 | 0 | 0 |
| Participant not willing to participate | 1 | 0 | 0 |
| Other | 3 | 0 | 0 |
| Period Title: Randomized Period | |||
| Started | 0 | 146 | 146 |
| Treated | 0 | 146 | 143 |
| Completed | 0 | 19 | 14 |
| Not Completed | 0 | 127 | 132 |
| Reason Not Completed | |||
| Death | 0 | 2 | 3 |
| Adverse Event | 0 | 23 | 25 |
| Global deterioration of health status | 0 | 6 | 7 |
| Lost to Follow-up | 0 | 1 | 0 |
| Objective progression or relapse | 0 | 77 | 86 |
| Withdrawal by Subject | 0 | 9 | 2 |
| Other | 0 | 9 | 6 |
| randomized but not treated | 0 | 0 | 3 |
Baseline Characteristics
| Arm/Group Title | Sunitinib 37.5 mg + Interferon Alpha-2b | Sunitinib 50 mg (Schedule 4/2) | Sunitinib 37.5 mg | Total | |
|---|---|---|---|---|---|
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Arm/Group Description |
Sunitinib 37.5 mg or 50 mg self administered orally once daily in the evening for 4 consecutive weeks followed by 2 weeks off (Schedule 4/2) to comprise a complete 6-weeks cycle. Concomitant Interferon (IFN) alpha-2b self-administered at a dose of 3 million units (MU) or 6 MU or 9MU subcutaneously (s.c.) 3 times weekly on non-consecutive days for up to 1 year (9 cycles) of treatment or early withdrawal. | Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle. | Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning. | Total of all reporting groups | |
| Overall Number of Baseline Participants | 25 | 146 | 146 | 317 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 25 participants | 146 participants | 146 participants | 317 participants | |
| 62.4 (7.2) | 60.4 (9.8) | 64.3 (9.7) | 62.4 (9.7) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 25 participants | 146 participants | 146 participants | 317 participants | |
| Female |
5 20.0%
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45 30.8%
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57 39.0%
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107 33.8%
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| Male |
20 80.0%
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101 69.2%
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89 61.0%
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210 66.2%
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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 less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 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.gov_Inquiries@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: | NCT00267748 |
| Other Study ID Numbers: |
A6181065 |
| First Submitted: | December 20, 2005 |
| First Posted: | December 21, 2005 |
| Results First Submitted: | June 23, 2011 |
| Results First Posted: | September 5, 2011 |
| Last Update Posted: | September 5, 2011 |