Temsirolimus Versus Sorafenib As Second-Line Therapy In Patients With Advanced RCC Who Have Failed First-Line Sunitinib (INTORSECT)
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|ClinicalTrials.gov Identifier: NCT00474786|
Recruitment Status : Completed
First Posted : May 17, 2007
Results First Posted : March 7, 2013
Last Update Posted : November 21, 2013
|Condition or disease||Intervention/treatment||Phase|
|Renal Cell Carcinoma||Drug: Sorafenib Drug: temsirolimus (Torisel)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||512 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Trial Of Temsirolimus Versus Sorafenib As Second-Line Therapy In Patients With Advanced Renal Cell Carcinoma Who Have Failed First-Line Sunitinib Therapy|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||January 2013|
Subjects randomized to arm B will take sorafenib 400 mg (2 x 200 mg tablets) PO, BID (total daily dose of 800 mg).
Drug: temsirolimus (Torisel)
Subjects randomized to arm A will receive temsirolimus (Torisel) 25 mg via IV infusion once weekly. This infusion is to be administered over a 30-60 minute period. Subjects are to be pre-treated with 25-50 mg IV diphenhydramine (or comparable IV antihistamine) approximately 30 minutes before temsirolimus infusion.
- Progression-Free Survival (PFS) [ Time Frame: Baseline up to 24 Months ]Interval from date of randomization until documentation of progressive disease (PD) by an independent tumor assessment according to Response Evaluation Criteria in Solid Tumor (RECIST) or death for any reason whichever occurred first.
- Progression Free Survival (PFS) by Investigator Assessment [ Time Frame: Baseline up to 24 Months ]Interval from date of randomization until documentation of PD by an investigator tumor assessment, symptomatic deterioration, or death for any reason whichever occurred first.
- Percentage of Participants With Tumor Response [ Time Frame: Baseline up to 24 Months ]Percentage of participants with tumor response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST and evaluated by independent central review. CR/PR persisted on repeat imaging study at least 4 weeks after initial documentation of response. PR had at least 30 percent decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.
- Overall Survival (OS) [ Time Frame: Baseline to date of death from any cause (up to 24 months) ]Overall survival was the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact.
- Percentage of Participants With PFS Events at 12, 24 and 36 Weeks by Independent Assessment [ Time Frame: Weeks 12, 24, and 36 ]PFS: Interval from date of randomization until documentation of PD by an independent tumor assessment according to RECIST or death for any reason whichever occurred first. PFS calculated as (Weeks)=(randomization date minus first dose date plus 1) divided by 7.
- Duration of Response (DR) [ Time Frame: Baseline up to 24 Months ]Duration of response as defined by the time from CR or PR (whichever status recorded first) until the date of death or PD was objectively documented. Median and its 95 percent confidence interval (95% CI) were estimated using Kaplan-Meier method.
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to 24 months ]Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to [study drug] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00474786
|Study Director:||Pfizer CT.gov Call Center||Pfizer|