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

Sponsored by:	Wyeth
Information provided by:	Wyeth
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
Renal Cell Carcinoma	Drug: Temsirolimus Drug: Sorafenib

MedlinePlus related topics: Cancer

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Wyeth:

Primary Outcome Measures:

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. [ Time Frame: 12-16 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Secondary Endpoints: PFS by investigator assessment; Response rate (CR and PR) by RECIST criteria: OS; SD at 12, 24, and 36 weeks; Duration of response; Best/maximum tumor shrinkage in target lesions [ Time Frame: Secondary Endpoints: PFS by investigator assessment; Response rate (CR and PR) by RECIST criteria: OS; PFS at 12, 24, and 36 weeks by independent assessment; Duration of response ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	480
Study Start Date:	July 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Sorafenib
2: Experimental	Drug: Temsirolimus

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

Contacts

Contact: Trial Manager

clintrialparticipation@wyeth.com

Show 113 Study Locations

Sponsors and Collaborators

Wyeth

More Information

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3066K1-404
Study First Received:	May 15, 2007
Last Updated:	January 14, 2009
ClinicalTrials.gov Identifier:	NCT00474786
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Urogenital Neoplasms
Renal cancer
Urologic Neoplasms
Kidney cancer
Carcinoma
Urologic Diseases
Kidney Neoplasms

Sunitinib
Carcinoma, Renal Cell
Kidney Diseases
Adenocarcinoma
Sorafenib
Urinary tract neoplasm
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009