Study VEG108844, a study of pazopanib versus sunitinib in the treatment of subjects with locally advanced and/or metastatic renal cell carcinoma - ND

Phase 1

• Conditions: Metastatic renal cell carcinoma; MedDRA version: 9.1Level: LLTClassification code 10050513Term: Metastatic renal cell carcinoma

• Registration Number: EUCTR2008-002102-19-IT
• Lead Sponsor: GlaxoSmithKline Research & Development Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-22
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 876

Inclusion Criteria

-Subjects must provide written informed consent prior to performance of any study-specific procedures or assessments,and must be willing to comply with treatment and follow up. Procedures conducted as part of the subject?s routine clinical management(e.g.blood count,imaging study)and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol.Note:It is not necessary that informed consent be obtained within the protocol-specified screening window. 2.Diagnosis of renal cell carcinoma with clear-cell component histology 3.Received no prior systemic therapy(interleukin-2,interferon-&#945;,chemotherapy,bevacizumab,mTOR inhibitor,sunitinib,sorafenib or other VEGF TKI)for advanced or metastatic RCC 4.Locally advanced(defined as disease not amenable to curative surgery or radiation therapy)or metastatic RCC(equivalent to Stage IV RCC according to AJCC staging)5.Must have measurable disease per RECIST.A measurable lesion is defined as a lesion that can be accurately measured in at least one dimension with the longest diameter&#8805;20mm using conventional techniques,or&#8805;10mm with spiral CTscan.Note:Subject should be excluded if all baseline measurable lesions are within previously irradiated areas 6.KPS of&#8805;70 7.Age&#8805;18 years old 8.A female is eligible to enter and participate in this study if she is of:Non-childbearing potential(i.e.physiologically incapable of becoming pregnant),including any female who has had:A hysterectomyA bilateral oophorectomy(ovariectomy)A bilateral tubal ligationIs post-menopausal Subjects not using hormone replacement therapy(HRT)must have experienced total cessation of menses for&#8805;1year and be greater than 45 years in age,OR,in questionable cases, have a follicle stimulating hormone(FSH)value>40mIU/mL and an estradiol value <40pg/mL(<140pmol/L).Subjects must discontinue HRT prior to study enrolment due to the potential for inhibition of Cytochrome P450(CYP)enzymes that metabolize estrogens and progestins.For most forms of HRT,at least 2-4 weeks must elapse between the cessation of HRT and determination of menopausal status;length of this interval depends on the type and dosage of HRT.If a female subject is determined not to be post-menopausal,they must use adequate contraception,as defined immediately below.Childbearing potential,including any female who has had a negative serum pregnancy test within 2 weeks prior to the first dose of study treatment,preferably as close to the first dose as possible,and agrees to use adequate contraception.GSK acceptable contraceptive methods,when used consistently and in accordance with both the product label and the instructions of the physician,are as follow:An intrauterine device with a documented failure rate of less than 1% per yearVasectomized partner who is sterile prior to the female subject?s entry and is the sole sexual partner for that femaleComplete abstinence from sexual intercourse for 14 days before exposure to investigational product,through the dosing period,and for at least 21 days after the last dose of investigational productDouble-barrier contraception(condom with spermicidal jelly,foam suppository or film;diaphragm with spermicide;or male condom and diaphragm with spermicide)Note:Oral contraceptives are not reliable due to potential drug-drug interactions.Female subjects who are lactating should discon

Exclusion Criteria

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Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to compare progression-free survival of subjects treated with pazopanib to those treated with sunitinib.;Secondary Objective: The secondary objectives are to compare the overall survival (OS), objective response rate, time to response, and duration of response of subjects treated with pazopanib to those treated with sunitinib, and to evaluate and compare the safety and quality of life of subjects treated with pazopanib to those treated with sunitinib.;Primary end point(s): The primary endpoint is progression free survival (PFS) defined as the interval between the date of randomization and the earliest date of disease progression (as defined by the independent reviewer) or death due to any cause.