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

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Duarte, California, 91010 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Cell Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00474786
Pfizer
Completed
Temsirolimus Versus Sorafenib As Second-Line Therapy In Patients With Advanced RCC Who Have Failed First-Line Sunitinib

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Temsirolimus Versus Sorafenib As Second-Line Therapy In Patients With Advanced RCC Who Have Failed First-Line Sunitinib
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Renal Cell Carcinoma
  • 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.
  • Experimental: 1
    Intervention: Drug: Sorafenib
  • Experimental: 2
    Intervention: Drug: temsirolimus (Torisel)
Grünwald V, Lin X, Kalanovic D, Simantov R. Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma. Eur Urol. 2016 Dec;70(6):1006-1015. doi: 10.1016/j.eururo.2016.05.010. Epub 2016 May 26.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
512
January 2013
January 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Austria,   Canada,   Chile,   China,   Denmark,   Finland,   France,   Germany,   Hungary,   Italy,   Korea, Republic of,   Netherlands,   Singapore,   Spain,   Sweden,   Switzerland,   United Kingdom,   United States
Hong Kong
 
NCT00474786
3066K1-404
B1771003
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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