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

Sponsor:	Pfizer
Information provided by (Responsible Party):	Pfizer
ClinicalTrials.gov Identifier:	NCT00474786

Purpose

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.

Condition	Intervention	Phase
Renal Cell Carcinoma	Drug: Sorafenib Drug: temsirolimus (Torisel)	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Sirolimus Everolimus CCI 779 Sorafenib Sunitinib malate Sorafenib tosylate Sunitinib

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Compare the safety and tolerability of temsirolimus and sorafenib when used as single agents in the second line setting in subjects with advanced RCC who have failed first line treatment with sunitinib due to progressive disease (PD) [ Time Frame: 12-18 weeks ] [ Designated as safety issue: Yes ]
Compare efficacy as measured by PFS (determined by a centralized independent assessment) of temsirolimus and sorafenib when used as a single agent in the second line setting in subjects with advanced RCC who have failed first line treatment with [ Time Frame: 12-18 weeks ] [ Designated as safety issue: No ]
sunitinib [ Time Frame: 12-18 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression Free Survival (PFS) by investigator assessment [ Time Frame: 12-18 weeks ] [ Designated as safety issue: No ]
Response rate (complete and partial) by Response Evaluation Criteria in Solid Tumors (RECIST) by independent assessment [ Time Frame: 12-18 weeks ] [ Designated as safety issue: No ]
Overall Survival [ Time Frame: 12-18 weeks ] [ Designated as safety issue: No ]
Proportion of subjects with PFS at 12, 24 and 36 weeks by independent assessment [ Time Frame: 12-18 weeks ] [ Designated as safety issue: No ]
Duration of Response [ Time Frame: 12-18 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	508
Study Start Date:	September 2007
Estimated Study Completion Date:	May 2014
Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	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).
Experimental: 2	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. Other Name: temsirolimus (Torisel)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00474786

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Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00474786 History of Changes
Other Study ID Numbers:	3066K1-404, B1771003
Study First Received:	May 15, 2007
Last Updated:	February 5, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sirolimus
Everolimus
Sorafenib

Sunitinib
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012