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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01180049
Other study ID # 3066K1-4438
Secondary ID B17710072009-015
Status Completed
Phase Phase 4
First received
Last updated
Start date March 2011
Est. completion date June 2018

Study information

Verified date May 2019
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will compare the effectiveness and safety of two different doses of temsirolimus (Torisel).


Recruitment information / eligibility

Status Completed
Enrollment 101
Est. completion date June 2018
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

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.

Study Design


Intervention

Drug:
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
temsirolimus
75mg IV once a week until until disease progression, provided that patient is tolerating treatment and getting clinical benefit

Locations

Country Name City State
Australia Royal Adelaide Hospital Adelaide South Australia
Australia Box Hill Hospital Box Hill Victoria
Australia Royal Hobart Hospital Hobart Tasmania
Australia St George Hospital Kogarah New South Wales
Australia The Alfred Hospital Melbourne Victoria
Czechia Fakultni nemocnice Kralovske Vinohrady Praha 10 Czech Republic
Czechia Fakultni nemocnice Kralovske Vinohrady Praha 10
Czechia Vseobecna fakultni nemocnice v Praze Praha 2
France CHU de Nancy Vandoeuvre les Nancy
Germany Klinik fuer Onkologie und Haematologie, Medizinische Klinik IV Aachen
Germany Klinikum Johannes-Gutenberg -Universitaet, III. Medizinische Klinik und Poliklinik Mainz
Italy Presidio Ferrarotto - A.O.U. - PoliclinicoVittorio Emanuele Catania
Italy Dipartimento di Medicina Diagnostica, Clinica e di Sanità Pubblica Modena
Italy Struttura Complessa di Ematologia, Dipartimento di Oncologia ed Ematologia- Torino
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Severance Hospital, Yonsei University Seoul
Poland Malopolskie Centrum Medyczne S.C. Krakow
Romania Institutul Clinic Fundeni Bucuresti, Sectia II Hematologie Bucuresti
Romania Spitalul Clinic Coltea, Clinica de Hematologie Bucuresti
Romania Spitalul Universitar de Urgenta Bucuresti, Clinica de Hematologie Bucuresti
Russian Federation Republican Clinical Oncology Dispensary of the Ministry of Healthcare of Tatarstan Republic Kazan
Russian Federation GBOU VPO "First Saint-Petersburg State Medical University n.a. I.P.Pavlov" Saint-Petersburg
Russian Federation Institute of Pediatric Hematology and Transplantology R.M.Gorbacheva Saint-Petersburg
Serbia Clinical Centre of Serbia,Clinic for Hematology Belgrade
Serbia Oncology Institute of Vojvodina Sremska Kamenica
United States Veterans Affairs New Jersey Healthcare System-Hematology/Oncology Section (111) East Orange New Jersey
United States Mercy Research Institute Miami Florida
United States Mercy Clinic Oklahoma Communities dba Mercy Clinic Oncology/Hematology-McAuley Oklahoma City Oklahoma
United States Mercy Hospital Oklahoma City-Oncology Infusion Oklahoma City Oklahoma
United States Amy Shen, RPh Seattle Washington
United States VA Puget Sound Health Care System Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Czechia,  France,  Germany,  Italy,  Korea, Republic of,  Poland,  Romania,  Russian Federation,  Serbia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Independently Assessed Progression-free Survival (PFS) 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.
From randomization date to the date of first documentation of progression or death (average follow up done for 15 months)
Secondary Overall Survival (OS) OS is defined as the time from the date of randomization to the date of death due to any cause. From randomization date until death due to any cause (average follow up done for 56.1 months)
Secondary Independent Assessment - Objective Response Rate (ORR = CR + PR) 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.
From randomization date until end of treatment (average follow up done for 15 months)
Secondary Investigator's Assessment ORR (ORR = CR + PR) 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.
From randomization date until end of treatment (average follow up done for 15 months)
Secondary Investigator Assessed PFS 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.
From randomization date to the date of first documentation of progression or death (average follow up done for 15 months)
Secondary 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) 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. From screening up to a maximum of 57.1 months
Secondary 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) 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. From screening up to a maximum of 57.1 months
Secondary Quantify the Potential Effect of TEMSR on AUC and Cmax 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
From one week predose (Day -7, -4hr, -8hr, -48hr) upto 2 weeks post dose (4hr, 8hr, 48hr and Day 8)
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