Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Temsirolimus Versus Sorafenib As Second-Line Therapy In Patients With Advanced RCC Who Have Failed First-Line Sunitinib (INTORSECT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00474786
Recruitment Status : Completed
First Posted : May 17, 2007
Results First Posted : March 7, 2013
Last Update Posted : November 21, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE May 15, 2007
First Posted Date  ICMJE May 17, 2007
Results First Submitted Date  ICMJE January 31, 2013
Results First Posted Date  ICMJE March 7, 2013
Last Update Posted Date November 21, 2013
Study Start Date  ICMJE September 2007
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2013)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 15, 2007)
To compare: safety,tolerability and efficacy (as measured by PFS), of temsirolimus and sorafenib when used as single agents in the second-line setting in subjects with advanced RCC who have failed prior first-line treatment with sunitinib.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2013)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2007)
Secondary Endpoints: Response rate (CR and PR) by RECIST criteria: OS; SD at 12, 24, and 36 weeks; Clinical benefit (CR + PR + SD >24 weeks);Duration of response;Best tumor shrinkage
Current Other Pre-specified Outcome Measures
 (submitted: January 31, 2013)
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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Temsirolimus Versus Sorafenib As Second-Line Therapy In Patients With Advanced RCC Who Have Failed First-Line Sunitinib
Official Title  ICMJE 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
Brief Summary This is an international, randomized, open-label, outpatient, multicenter study. Subjects will be assigned in a 1:1 ratio to 1 of 2 treatment arms: temsirolimus 25 mg once weekly by intravenous (IV) infusion or sorafenib 400 mg by mouth (PO) twice daily (BID). These investigational drugs will be administered in 6-week cycles for the duration of the study, up to 24 months. Subjects will be stratified by nephrectomy status, duration of response to sunitinib therapy, Memorial Sloan Kettering Cancer Center (MSKCC) prognostic group, and RCC tumor histology.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Renal Cell Carcinoma
Intervention  ICMJE
  • Drug: Sorafenib
    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.
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: Sorafenib
  • Experimental: 2
    Intervention: Drug: temsirolimus (Torisel)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 18, 2012)
512
Original Enrollment  ICMJE
 (submitted: May 15, 2007)
440
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed diagnosis of mRCC (regardless of histology or nephrectomy status) with well-documented Radiological PD by RECIST criteria or clinical PD as judged by the investigator while receiving first-line sunitinib therapy. Subjects must have at least 1 cycle of sunitinib therapy (minimum of four weeks continuously).
  • At time of randomization, at least 2 weeks since prior treatment with sunitinib, palliative radiation therapy, and/or surgery.
  • At time of randomization, there must be at least 1 measurable lesion per RECIST. Lesions that have been previously irradiated or embolized cannot be selected as target lesions.

    • More criteria apply

Exclusion Criteria:

  • Metastatic CNS from RCC.
  • Subjects who discontinued Sutent therapy due specifically to intolerance.
  • Prior systemic therapy for mRCC other than sunitinib.
  • Active ketonuria, secondary to poorly controlled diabetes mellitus

    • More criteria apply
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Canada,   Chile,   China,   Denmark,   Finland,   France,   Germany,   Hungary,   Italy,   Korea, Republic of,   Netherlands,   Singapore,   Spain,   Sweden,   Switzerland,   United Kingdom,   United States
Removed Location Countries Hong Kong
 
Administrative Information
NCT Number  ICMJE NCT00474786
Other Study ID Numbers  ICMJE 3066K1-404
B1771003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP