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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01180049
Registration number
NCT01180049
Ethics application status
Date submitted
9/08/2010
Date registered
11/08/2010
Titles & IDs
Public title
Comparison Of 2 Doses Of Temsirolimus (Torisel) In Patients With Mantle Cell Lymphoma
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Scientific title
A RANDOMIZED PHASE 4 STUDY COMPARING 2 INTRAVENOUS TEMSIROLIMUS (TEMSR) REGIMENS IN SUBJECTS WITH RELAPSED, REFRACTORY MANTLE CELL LYMPHOMA
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Secondary ID [1]
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B1771007
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Secondary ID [2]
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3066K1-4438
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-Hodgkin's Lymphoma
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - temsirolimus
Treatment: Drugs - temsirolimus
Active comparator: temsirolimus (Torisel) 175mg weekly x 3, then 75mg weekly -
Active comparator: temsirolimus (Torisel) 75mg weekly -
Treatment: Drugs: temsirolimus
175mg IV once a week for first 3 weeks, followed by 75mg IV once a week until disease progression, provided that patient is tolerating treatment and getting clinical benefit
Treatment: Drugs: temsirolimus
75mg IV once a week until until disease progression, provided that patient is tolerating treatment and getting clinical benefit
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Independently Assessed Progression-free Survival (PFS)
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Assessment method [1]
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PFS is defined as the time from randomization to first documentation of disease progression by the independent assessor or to death due to any cause, whichever occurred first.
PFS = (earliest date of progression or death due to any cause- randomization date+1)/30.4.
PFS assessment was done using EMA guidelines for sensitivity analysis censoring.
Participants who were alive and progression-free at the time of analysis were censored on the date of last assessment; participants without adequate baseline assessment or without post-baseline assessments were censored on the randomization date; participants who died or progressed after 2 or more missed visits were censored on the date of last tumor assessment prior to the missing visit; and participants who started new anti-cancer therapy prior to death or progression were censored on the date of last tumor assessment prior to the start of anti-tumor treatment.
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Timepoint [1]
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From randomization date to the date of first documentation of progression or death (average follow up done for 15 months)
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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OS is defined as the time from the date of randomization to the date of death due to any cause.
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Timepoint [1]
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From randomization date until death due to any cause (average follow up done for 56.1 months)
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Secondary outcome [2]
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Independent Assessment - Objective Response Rate (ORR = CR + PR)
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Assessment method [2]
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ORR is defined as the percentage of participants with confirmed CR or PR according to the Cheson Criteria relative to all randomized Participants. Tumor responses were determined using information from objective measurements from computed tomography information including B-symptom evaluation, physical examination, ECOG performance status, assessment of liver and spleen, laboratory assessments such as bone marrow biopsies and/or aspirates, biochemical markers of disease activity and hematology results.
Participants who did not have on-study radiographic tumor re-evaluation or who died, progressed or dropped out for any reason prior to reaching a CR or PR were counted as non-responders in the (CT) scans, as well as clinical assessment of ORR.
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Timepoint [2]
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From randomization date until end of treatment (average follow up done for 15 months)
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Secondary outcome [3]
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Investigator's Assessment ORR (ORR = CR + PR)
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Assessment method [3]
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ORR is defined as the percentage of participants with confirmed CR or PR according to the Cheson Criteria relative to all randomized Participants. Tumor responses were determined using information from objective measurements from computed tomography information including B-symptom evaluation, physical examination, ECOG performance status, assessment of liver and spleen, laboratory assessments such as bone marrow biopsies and/or aspirates, biochemical markers of disease activity and hematology results.
Participants who did not have on-study radiographic tumor re-evaluation or who died, progressed or dropped out for any reason prior to reaching a CR or PR were counted as non-responders in the (CT) scans, as well as clinical assessment of ORR.
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Timepoint [3]
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From randomization date until end of treatment (average follow up done for 15 months)
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Secondary outcome [4]
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Investigator Assessed PFS
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Assessment method [4]
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PFS is defined as the time from randomization to first documentation of disease progression by the independent assessor or to death due to any cause, whichever occurred first.
PFS = (earliest date of progression or death due to any cause- randomization date+1)/30.4.
PFS assessment was done using EMA guidelines for sensitivity analysis censoring.
Participants who were alive and progression-free at the time of analysis were censored on the date of last assessment; participants without adequate baseline assessment or without post-baseline assessments were censored on the randomization date; participants who died or progressed after 2 or more missed visits were censored on the date of last tumor assessment prior to the missing visit; and participants who started new anti-cancer therapy prior to death or progression were censored on the date of last tumor assessment prior to the start of anti-tumor treatment.
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Timepoint [4]
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From randomization date to the date of first documentation of progression or death (average follow up done for 15 months)
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Secondary outcome [5]
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Percentage of Participants With Treatment-Emergent Infection- Related Adverse Events (AEs) With Grade 2 or Higher as Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
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Assessment method [5]
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An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Treatment emergent adverse event=as an event that emerged during treatment period that was absent before treatment, or worsened during treatment period relative to pretreatment state. Treatment-emergent infection-related AEs included events: pneumonia, bronchitis, infection, herpes simplex, oral candidiasis and sepsis. Grading by NCI CTCAE Version 3.0.: Grade 1= mild; Grade 2= moderate; Grade 3= severe; Grade 4= life-threatening; urgent intervention indicated; Grade 5= death.
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Timepoint [5]
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From screening up to a maximum of 57.1 months
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Secondary outcome [6]
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Percentage of Participants With Treatment-Emergent Bleeding-Related AEs With Grade 2 or Higher as Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
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Assessment method [6]
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An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Treatment emergent adverse event=as an event that emerged during treatment period that was absent before treatment, or worsened during treatment period relative to pretreatment state. Treatment-emergent bleeding related AEs included events: epistaxis and ecchymosis. AE were assessed according to maximum severity grading based on NCI CTCAE Version 4.03.Grade 1=mild; Grade 2=moderate; within normal limits. Grade 3=severe or medically significant but not immediately life-threatening; Grade 4=life-threatening or disabling; urgent intervention indicated; Grade 5=death.
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Timepoint [6]
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From screening up to a maximum of 57.1 months
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Secondary outcome [7]
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Quantify the Potential Effect of TEMSR on AUC and Cmax
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Assessment method [7]
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Potential TEMSR effects were investigated by calculating the ratio of AUCs with and without concomitant TEMSR from the model-estimated effect of TEMSR on apparent clearance (CL/F) values and using individual ratios of observed Cmax values with and without concomitant temsirolimus, for both parent and metabolite. The AUC mean ratio was calculated as 1 / mean shift on apparent clearance from TEMSR, and the 90% CI of the AUC ratios was calculated as 1 / 90% CI of the shift on apparent clearance from TEMSR.
AUC: Area under plasma concentration-time curve from time zero to infinity Cmax: Characterization of maximum observed plasma concentration
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Timepoint [7]
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From one week predose (Day -7, -4hr, -8hr, -48hr) upto 2 weeks post dose (4hr, 8hr, 48hr and Day 8)
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Eligibility
Key inclusion criteria
* Have confirmed mantle cell lymphoma diagnosis.
* Have measurable disease.
* Have received at least 2 prior treatment, which may include stem cell transplant.
* Have adequate organ and bone marrow function.
* There are other criteria--please discuss with your doctor.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Had any prior treatment with temsirolimus or mTOR inhibitor.
* Had allogeneic stem cell transplant within last 6 months and on immunosuppressive therapy.
* Has active or untreated brain or central nervous system metastases.
* There are other criteria--please discuss with your doctor.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/06/2018
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Sample size
Target
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Accrual to date
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Final
101
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Recruitment in Australia
Recruitment state(s)
NSW,SA,TAS,VIC
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Recruitment hospital [1]
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St George Hospital - Kogarah
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Recruitment hospital [2]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [3]
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Royal Hobart Hospital - Hobart
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Recruitment hospital [4]
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Box Hill Hospital - Box Hill
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Recruitment hospital [5]
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The Alfred Hospital - Melbourne
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Recruitment postcode(s) [1]
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2217 - Kogarah
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Recruitment postcode(s) [2]
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5000 - Adelaide
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Recruitment postcode(s) [3]
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7000 - Hobart
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Recruitment postcode(s) [4]
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3128 - Box Hill
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Recruitment postcode(s) [5]
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3004 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Florida
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Country [2]
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United States of America
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State/province [2]
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New Jersey
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Country [3]
0
0
United States of America
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State/province [3]
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Oklahoma
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Country [4]
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0
United States of America
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State/province [4]
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Washington
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Country [5]
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Czechia
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State/province [5]
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Czech Republic
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Country [6]
0
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Czechia
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State/province [6]
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Praha 10
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Country [7]
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Czechia
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State/province [7]
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Praha 2
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Country [8]
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France
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State/province [8]
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Vandoeuvre les Nancy
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Country [9]
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Germany
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State/province [9]
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Aachen
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Country [10]
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Germany
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State/province [10]
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Mainz
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Country [11]
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Italy
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State/province [11]
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Catania
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Country [12]
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Italy
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State/province [12]
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Modena
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Country [13]
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Italy
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State/province [13]
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Torino
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Country [14]
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Korea, Republic of
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State/province [14]
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Seoul
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Country [15]
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Poland
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State/province [15]
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Krakow
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Country [16]
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Romania
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State/province [16]
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Bucuresti
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Country [17]
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Russian Federation
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State/province [17]
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Kazan
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Country [18]
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Russian Federation
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State/province [18]
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Saint-Petersburg
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Country [19]
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Serbia
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State/province [19]
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Belgrade
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Country [20]
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Serbia
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State/province [20]
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Sremska Kamenica
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Pfizer
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will compare the effectiveness and safety of two different doses of temsirolimus (Torisel).
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Trial website
https://clinicaltrials.gov/study/NCT01180049
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Pfizer CT.gov Call Center
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Address
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Pfizer
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01180049