AzTrials
AzTrials

Carcinoma, Renal CellPhase 2NCT00244764

GW786034 In Subjects With Locally Recurrent Or Metastatic Clear Cell Renal Cell Carcinoma

A Phase 2 study testing GW786034 in people with Carcinoma, Renal Cell, run by GlaxoSmithKline at 45 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Carcinoma, Renal Cell
What is being tested?
GW786034
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
225 participants
Where
45 sitesin 8 countries
Study dates
Oct 2005to Sep 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who:
Show all 23Show fewer
  • 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).
  • 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.

Who cannot join

  • 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.
Show all 19Show fewer
  • 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.

Trial locations and contacts

45 sites in 8 countries.

45 sites in 8 countries

United States12 sites

  • GSK Investigational Site

    Aurora, Colorado, 80010

  • GSK Investigational Site

    Cleveland, Ohio, 44106

  • GSK Investigational Site

    Cleveland, Ohio, 44195

  • GSK Investigational Site

    Dallas, Texas, 75246

  • GSK Investigational Site

    Duarte, California, 91010-3000

  • GSK Investigational Site

    Indianapolis, Indiana, 46202

  • GSK Investigational Site

    Los Angeles, California, 90095

  • GSK Investigational Site

    Nashville, Tennessee, 37203

  • GSK Investigational Site

    New York, New York, 10032-3713

  • GSK Investigational Site

    Orange, California, 92868

  • GSK Investigational Site

    San Francisco, California, 94115

  • GSK Investigational Site

    Tucker, Georgia, 30084

Other trials in United States

Australia7 sites

  • GSK Investigational Site

    Camperdown, New South Wales, 2050

  • GSK Investigational Site

    East Melbourne, Victoria, 3002

  • GSK Investigational Site

    Footscay, Victoria, 3011

  • GSK Investigational Site

    Heidelberg, Victoria, 3084

  • GSK Investigational Site

    Kogarah, New South Wales, 2217

  • GSK Investigational Site

    Parkville, Victoria, 3050

  • GSK Investigational Site

    Randwick, New South Wales, 2031

Other trials in Australia

Belgium7 sites

  • GSK Investigational Site

    Brussels, 1070

  • GSK Investigational Site

    Brussels, 1200

  • GSK Investigational Site

    Ghent, 9000

  • GSK Investigational Site

    Jette, 1090

  • GSK Investigational Site

    Liège, 4000

  • GSK Investigational Site

    Roeselare, 8800

  • GSK Investigational Site

    Wilrijk, 2610

Other trials in Belgium

China7 sites

  • GSK Investigational Site

    Beijing, 100034

  • GSK Investigational Site

    Beijing, 100853

  • GSK Investigational Site

    Guangzhou, Guangdong, 510060

  • GSK Investigational Site

    Hangzhou, Zhejiang, 310003

  • GSK Investigational Site

    Jinan, Shandong, 250012

  • GSK Investigational Site

    Nanjing, Jiangsu, 210029

  • GSK Investigational Site

    Shanghai, 200040

Other trials in China

Israel4 sites

  • GSK Investigational Site

    Haifa, 31096

  • GSK Investigational Site

    Petah Tikva, 49100

  • GSK Investigational Site

    Tel Aviv, 64239

  • GSK Investigational Site

    Zrifin, 70300

Other trials in Israel

Czechia3 sites

  • GSK Investigational Site

    Brno, 656 53

  • GSK Investigational Site

    Hradec Králové, 500 05

  • GSK Investigational Site

    Prague, 12808

Other trials in Czechia

Hong Kong3 sites

  • GSK Investigational Site

    Hong Kong

  • GSK Investigational Site

    Kowloon

  • GSK Investigational Site

    Tuenmen

Other trials in Hong Kong

Taiwan2 sites

  • GSK Investigational Site

    Taipei, 100

  • GSK Investigational Site

    Taipei

Other trials in Taiwan

About this study

Official title: A Phase II Study of GW786034 Using a Randomised Discontinuation Design in Subjects With Locally Recurrent or Metastatic Clear-Cell Renal Cell Carcinoma

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.

Being tested
GW786034, Placebo
Keywords
Angiogenesis, Renal Cell Carcinoma, Solid tumors, Pazopanib(GW786034)
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GW786034Drug

    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.

  • PlaceboDrug

    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.

Study groups in NCT00244764
Study groupRoleWhat they receive
PazopanibExperimentalAll 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.
Receives: Drug: GW786034
PlaceboPlacebo comparatorAll 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response by RECIST Criteria

    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.

    Measured: Baseline to Response (up to 2.40 years). Assessments occurred at Week 12 and every 8 weeks thereafter.

  2. Stable Disease at 12 Weeks - Interim Analysis of First 60 Participants

    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.

    Measured: Week 12

Secondary outcomes (2)

  1. Duration of Response

    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.

    Measured: First response until progression of disease (up to 2.40 years). Assessments occurred at Week 12 and every 8 weeks thereafter.

  2. Progression-free Survival

    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.

    Measured: From the first day of treatment to the earliest date of disease progression or death due to any cause (up to 2.40 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2005 (estimated)
  2. Study startOct 2005
  3. Primary completionMar 2008
  4. Study completionSep 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
225 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00244764
Sponsor's protocol ID
VEG102616
Status last verified
Sep 2015
First submitted
25 Oct 2005
Last updated
27 Mar 2017
Data monitoring committee
Yes

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.

    PubMed 23715625

  • 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.

    PubMed 20008644

  • 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.

    PubMed 22759480

  • 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.

    PubMed 17920711

  • 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.

    PubMed 21145803

  • 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.

    PubMed 20389299

  • 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.

    PubMed 26702763

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GW786034 in people with Carcinoma, Renal Cell, run by GlaxoSmithKline at 45 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in United States, Australia, Belgium, China, Israel and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jan 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response by RECIST Criteria (time frame: Baseline to Response (up to 2.40 years). Assessments occurred at Week 12 and every 8 weeks thereafter.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00244764, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in