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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00244764
Registration number
NCT00244764
Ethics application status
Date submitted
25/10/2005
Date registered
27/10/2005
Date last updated
27/03/2017
Titles & IDs
Public title
GW786034 In Subjects With Locally Recurrent Or Metastatic Clear Cell Renal Cell Carcinoma
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Scientific title
A Phase II Study of GW786034 Using a Randomised Discontinuation Design in Subjects With Locally Recurrent or Metastatic Clear-Cell Renal Cell Carcinoma
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Secondary ID [1]
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VEG102616
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Renal Cell
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Condition category
Condition code
Cancer
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Non melanoma skin cancer
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Cancer
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Kidney
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - GW786034
Treatment: Drugs - Placebo
Experimental: 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.
Placebo Comparator: 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.
Treatment: Drugs: 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.
Treatment: Drugs: 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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Response by RECIST Criteria
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Assessment method [1]
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The overall response is the number of participants who experience a confirmed complete (CR) or partial response (PR) of the total analysis population. Per the Response Evaluation Criteria In Solid Tumors (RECIST): CR = all detectable tumor has disappeared, PR = a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum, Progressive disease (PD) = a >=20% increase in target lesions, Stable Disease = small changes that do not meet previously given criteria.
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Timepoint [1]
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Baseline to Response (up to 2.40 years). Assessments occurred at Week 12 and every 8 weeks thereafter.
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Primary outcome [2]
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Stable Disease at 12 Weeks - Interim Analysis of First 60 Participants
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Assessment method [2]
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The protocol called for an interim analysis of the first 60 participants to determine their status at Week 12, and to determine the number of participants with stable disease, although all categories were reported. Stable disease is defined as a disease that has not grown enough to be called progressive disease and has not shrunk enough to be called partial/complete response.
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Timepoint [2]
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Week 12
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Secondary outcome [1]
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Duration of Response
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Assessment method [1]
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Using RECIST criteria: date of first confirmed tumor response (CR or PR) to date of tumor progression or to death. Participants who did not progress or die were censored at their last radiologic assessment. Only participants who had a response were analyzed.
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Timepoint [1]
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First response until progression of disease (up to 2.40 years). Assessments occurred at Week 12 and every 8 weeks thereafter.
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Secondary outcome [2]
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Progression-free Survival
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Assessment method [2]
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Progression-free Survival is defined as the interval between the first day of treatment and the earliest date of disease progression or death due to any cause, whichever occurred first. Progressive disease is defined as a >=20% increase in target lesions.
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Timepoint [2]
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From the first day of treatment to the earliest date of disease progression or death due to any cause (up to 2.40 years)
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Eligibility
Key inclusion criteria
Inclusion criteria:
- Histologically or cytologically confirmed diagnosis of Renal Cell Carcinoma of
predominantly clear-cell histology (excluding chromophobe, papillary, collecting duct,
and undifferentiated tumors) which is metastatic or locally recurrent
- 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.
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Minimum age
21
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria:
- Received prior non-cytokine or non-bevacizumab therapies .
- 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/09/2013
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Sample size
Target
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Accrual to date
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Final
225
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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GSK Investigational Site - Camperdown
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Recruitment hospital [2]
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GSK Investigational Site - Kogarah
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Recruitment hospital [3]
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GSK Investigational Site - Randwick
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Recruitment hospital [4]
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GSK Investigational Site - East Melbourne
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Recruitment hospital [5]
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GSK Investigational Site - Footscay
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Recruitment hospital [6]
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GSK Investigational Site - Heidelberg
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Recruitment hospital [7]
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GSK Investigational Site - Parkville
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2217 - Kogarah
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Recruitment postcode(s) [3]
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2031 - Randwick
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Recruitment postcode(s) [4]
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3002 - East Melbourne
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Recruitment postcode(s) [5]
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3011 - Footscay
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Recruitment postcode(s) [6]
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3084 - Heidelberg
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Recruitment postcode(s) [7]
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3050 - Parkville
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Recruitment outside Australia
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United States of America
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California
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Colorado
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Georgia
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Indiana
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New York
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Ohio
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Tennessee
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Texas
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Belgium
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Bruxelles
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Gent
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Belgium
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Jette
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Belgium
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Liège
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Belgium
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Roeselare
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Belgium
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Wilrijk
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China
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Guangdong
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China
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Jiangsu
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China
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Shandong
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China
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Zhejiang
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China
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Beijing
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China
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Shanghai
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Czech Republic
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Brno
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Hradec Kralove
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Praha 2
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Kowloon
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Hong Kong
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Tuen Mun
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Israel
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Haifa
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Israel
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Petach Tikva
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Israel
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Tel Aviv
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Israel
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Zrifin
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Taiwan
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Taipei
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
GlaxoSmithKline
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
Phase II, multi-center, two-stage study utilising a randomised discontinuation design to
evaluate the safety and efficacy of GW786034 (pazopanib) in adult subjects with locally
recurrent or metastatic clear-cell Renal Cell Carcinoma (RCC). After the interim analysis,
the design was changed to an open label, single arm study with all subjects receiving
pazopanib.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00244764
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Trial related presentations / publications
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.
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Public notes
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Contacts
Principal investigator
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GSK Clinical Trials
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Address
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GlaxoSmithKline
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00244764
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