GW786034 In Subjects With Locally Recurrent Or Metastatic Clear Cell Renal Cell Carcinoma
NCT ID: NCT00244764
Last Updated: 2017-03-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
225 participants
INTERVENTIONAL
2005-10-31
2013-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pazopanib
All patients receive GW786034. At week 12, some subjects will be randomized based on response (SD) and the others will remain on drug. After the interim analysis, the design was changed to an open label, single arm study with all subjects receiving pazopanib.
GW786034
All patients receive GW786034. At week 12, some subjects will be randomized based on response (SD) and the others will remain on drug. After the interim analysis, the design was changed to an open label, single arm study with all subjects receiving pazopanib.
Placebo
All patients receive GW786034. At week 12, some subjects will be randomized based on response (SD) and the others will remain on drug. After the interim analysis, the design was changed to an open label, single arm study with all subjects receiving pazopanib.
Placebo
All patients receive GW786034. At week 12, some subjects will be randomized based on response (SD) and the others will remain on drug. After the interim analysis, the design was changed to an open label, single arm study with all subjects receiving pazopanib.
Interventions
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GW786034
All patients receive GW786034. At week 12, some subjects will be randomized based on response (SD) and the others will remain on drug. After the interim analysis, the design was changed to an open label, single arm study with all subjects receiving pazopanib.
Placebo
All patients receive GW786034. At week 12, some subjects will be randomized based on response (SD) and the others will remain on drug. After the interim analysis, the design was changed to an open label, single arm study with all subjects receiving pazopanib.
Eligibility Criteria
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Inclusion Criteria
* Either no prior systemic therapy or failed only 1 prior cytokine-based or bevacizumab-based therapy
* Evidence of documented measurable disease by RECIST criteria
* Male or female at least 21 years of age
A woman is eligible to enter and participate in the study if she is of:
1. Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who:
* Has had a hysterectomy,
* Has had a bilateral oophorectomy (ovariectomy),
* Has had a bilateral tubal ligation,
* Is post-menopausal (total cessation of menses for \>= 1 year).
2. Childbearing potential, has a negative serum pregnancy test at Screening Period and serum or urine pregnancy test at Day1, 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 follows:
* An intrauterine device (IUD) with a documented failure rate of less than 1% per year.
* Vasectomized partner who is sterile prior to the female subject's entry and is the sole sexual partner for that female.
* Complete abstinence from sexual intercourse for 14 days before exposure to investigation product, through the clinical trial, and for at least 21 days after the last dose of investigational product.
* Double-barrier contraception (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm with spermicide).
A man with a female partner of childbearing potential is eligible to enter and participate in the study if he uses a barrier method of contraception (e.g. condom) or abstinence during the study and for 28 days following the last dose of investigational drug.
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
* Adequate bone marrow function.
* Adequate hepatic function.
* Adequate renal function.
* Adequate PT/PTT or INR/aPTT.
* Able to swallow and retain oral medications.
* Written informed consent.
Exclusion Criteria
* Received chemotherapy for renal cell carcinoma.
* Have had any major surgery, radiotherapy, or immunotherapy within the last 28 days and/or not recovered from prior therapy.
* History of hypercalcemia within two months of start of therapy.
* Patients who are pregnant or lactating.
* Poorly controlled hypertension.
* QTc prolongation defined as a QTc interval ≥ 480 msecs or other significant ECG abnormalities.
* Has Class II, III or IV heart failure as defined by the New York Heart Association functional classification system. A subject who has a history of Class II heart failure and is asymptomatic on treatment may be considered eligible.
* Any history of cerebrovascular accident \[CVA\].
* History of myocardial infarction, admission for unstable angina, cardiac angioplasty or stenting within the last 12 weeks.
* History of venous thrombosis in last 12 weeks.
* Current use of therapeutic warfarin.
* Use of antiplatelet agents other than aspirin (≤ 325 mg/day).
* Leptomeningeal or brain metastases.
* Prior history of malignancies other than renal cell carcinoma (except for basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or the subject has been free of any other malignancies for \> 5 years).
* Any serious and/or unstable pre-existing medical, psychiatric, or other condition (including lab abnormalities) that could interfere with subject safety or obtaining informed consent.
* History of malabsorption syndrome, disease significantly affecting gastrointestinal function or major resection of the stomach or small bowel that could affect absorption, distribution, metabolism or excretion of study drugs. Has any unresolved bowel obstruction or diarrhea.
* Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
* Is on any specifically prohibited medication or requires any of these medications during treatment with GW786034.
21 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Duarte, California, United States
GSK Investigational Site
Los Angeles, California, United States
GSK Investigational Site
Orange, California, United States
GSK Investigational Site
San Francisco, California, United States
GSK Investigational Site
Aurora, Colorado, United States
GSK Investigational Site
Tucker, Georgia, United States
GSK Investigational Site
Indianapolis, Indiana, United States
GSK Investigational Site
New York, New York, United States
GSK Investigational Site
Cleveland, Ohio, United States
GSK Investigational Site
Cleveland, Ohio, United States
GSK Investigational Site
Nashville, Tennessee, United States
GSK Investigational Site
Dallas, Texas, United States
GSK Investigational Site
Camperdown, New South Wales, Australia
GSK Investigational Site
Kogarah, New South Wales, Australia
GSK Investigational Site
Randwick, New South Wales, Australia
GSK Investigational Site
East Melbourne, Victoria, Australia
GSK Investigational Site
Footscay, Victoria, Australia
GSK Investigational Site
Heidelberg, Victoria, Australia
GSK Investigational Site
Parkville, Victoria, Australia
GSK Investigational Site
Brussels, , Belgium
GSK Investigational Site
Brussels, , Belgium
GSK Investigational Site
Ghent, , Belgium
GSK Investigational Site
Jette, , Belgium
GSK Investigational Site
Liège, , Belgium
GSK Investigational Site
Roeselare, , Belgium
GSK Investigational Site
Wilrijk, , Belgium
GSK Investigational Site
Guangzhou, Guangdong, China
GSK Investigational Site
Nanjing, Jiangsu, China
GSK Investigational Site
Jinan, Shandong, China
GSK Investigational Site
Hangzhou, Zhejiang, China
GSK Investigational Site
Beijing, , China
GSK Investigational Site
Beijing, , China
GSK Investigational Site
Shanghai, , China
GSK Investigational Site
Brno, , Czechia
GSK Investigational Site
Hradec Králové, , Czechia
GSK Investigational Site
Prague, , Czechia
GSK Investigational Site
Hong Kong, , Hong Kong
GSK Investigational Site
Kowloon, , Hong Kong
GSK Investigational Site
Tuenmen, , Hong Kong
GSK Investigational Site
Haifa, , Israel
GSK Investigational Site
Petah Tikva, , Israel
GSK Investigational Site
Tel Aviv, , Israel
GSK Investigational Site
Zrifin, , Israel
GSK Investigational Site
Taipei, , Taiwan
GSK Investigational Site
Taipei, , Taiwan
Countries
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References
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Bonate PL, Suttle AB. Modeling tumor growth kinetics after treatment with pazopanib or placebo in patients with renal cell carcinoma. Cancer Chemother Pharmacol. 2013 Jul;72(1):231-40. doi: 10.1007/s00280-013-2191-0. Epub 2013 May 29.
Hutson TE, Davis ID, Machiels JP, De Souza PL, Rottey S, Hong BF, Epstein RJ, Baker KL, McCann L, Crofts T, Pandite L, Figlin RA. Efficacy and safety of pazopanib in patients with metastatic renal cell carcinoma. J Clin Oncol. 2010 Jan 20;28(3):475-80. doi: 10.1200/JCO.2008.21.6994. Epub 2009 Dec 14.
Tran HT, Liu Y, Zurita AJ, Lin Y, Baker-Neblett KL, Martin AM, Figlin RA, Hutson TE, Sternberg CN, Amado RG, Pandite LN, Heymach JV. Prognostic or predictive plasma cytokines and angiogenic factors for patients treated with pazopanib for metastatic renal-cell cancer: a retrospective analysis of phase 2 and phase 3 trials. Lancet Oncol. 2012 Aug;13(8):827-37. doi: 10.1016/S1470-2045(12)70241-3. Epub 2012 Jul 2.
White AJ, LaGerche A, Toner GC, Whitbourn RJ. Apical ballooning syndrome during treatment with a vascular endothelial growth factor receptor antagonist. Int J Cardiol. 2009 Jan 24;131(3):e92-4. doi: 10.1016/j.ijcard.2007.07.066. Epub 2007 Oct 24.
Xu CF, Reck BH, Goodman VL, Xue Z, Huang L, Barnes MR, Koshy B, Spraggs CF, Mooser VE, Cardon LR, Pandite LN. Association of the hemochromatosis gene with pazopanib-induced transaminase elevation in renal cell carcinoma. J Hepatol. 2011 Jun;54(6):1237-43. doi: 10.1016/j.jhep.2010.09.028. Epub 2011 Feb 12.
Xu CF, Reck BH, Xue Z, Huang L, Baker KL, Chen M, Chen EP, Ellens HE, Mooser VE, Cardon LR, Spraggs CF, Pandite L. Pazopanib-induced hyperbilirubinemia is associated with Gilbert's syndrome UGT1A1 polymorphism. Br J Cancer. 2010 Apr 27;102(9):1371-7. doi: 10.1038/sj.bjc.6605653. Epub 2010 Apr 13.
Goldstein D, Rosenberg JE, Figlin RA, Townsend RR, McCann L, Carpenter C, Pandite L. Is change in blood pressure a biomarker of pazopanib and sunitinib efficacy in advanced/metastatic renal cell carcinoma? Eur J Cancer. 2016 Jan;53:96-104. doi: 10.1016/j.ejca.2015.10.006. Epub 2015 Dec 15.
Other Identifiers
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VEG102616
Identifier Type: -
Identifier Source: org_study_id
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