Last updated: 11/07/2018 05:36:41
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on clinicaltrials.gov.
Pazopanib Versus Sunitinib in the Treatment of Asian Subjects with Locally Advanced and/or Metastatic Renal Cell Carcinoma
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Trial overview
Official title: A Study to Evaluate Efficacy and Safety of Pazopanib versus Sunitinib for the Treatment of Asian Subjects with Locally Advanced and/or Metastatic Renal Cell Carcinoma – A substudy to VEG108844
Trial description: This study is being conducted to provide a direct comparison of the efficacy, safety, and tolerabilityfor pazopanib and sunitinib (SUTENT) in the Asian population.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Progression-free Survival (PFS)
Timeframe: From randomization to the earliest date of disease progression or death (up to 39 months)
Secondary outcomes:
Overall Survival (OS)
Timeframe: From randomization until death (up to 44 months)
Number of participants with a best response of confirmed complete response (CR) or confirmed partial response (PR) as assessed by the IRC
Timeframe: From Baseline until the time of response or the earliest date of disease progression/death (up to 39 months)
Time to response
Timeframe: From Baseline until the time of response or the earliest date of disease progression/death (up to 39 months)
Duration of response (DOR)
Timeframe: From the time of response until the earliest date of disease progression/death (up to 38 months)
Interventions:
Enrollment:
183
Primary completion date:
2012-21-05
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Motzer R, Hutson T, Cella D, et al. Pazopanib Versus Sunitinib in Metastatic Renal-Cell Carcinoma. N Engl J Med. 2013;369(8):722-731.
Medical condition
Carcinoma, Renal Cell
Product
pazopanib, sunitinib
Collaborators
Not applicable
Study date(s)
May 2010 to March 2018
Type
Interventional
Phase
2/3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
none
- Written informed consent
- Diagnosis of renal cell carcinoma with clear-cell component histology.
- Pregnant or lactating female (unless agrees to refrain from nursing throughout the treatment period and for 14 days following the last dose of study)-History of another malignancy (unless have been disease-free for 3 years)
- History or clinical evidence of central nervous system (CNS) metastases (unless have previously-treated CNS metastases and meet all 3 of the following criteria are: are asymptomatic, have had no evidence of active CNS metastases for >=6 months prior to enrolment, and have no requirement for steroids or enzyme-inducing anticonvulsants)
Inclusion and exclusion criteria
Inclusion criteria:
- Written informed consent
- Diagnosis of renal cell carcinoma with clear-cell component histology.
- Received no prior systemic therapy (interleukin-2, interferon-alpha, chemotherapy, bevacizumab, mTOR inhibitor, sunitinib, sorafenib or other VEGF TKI) for advanced or metastatic RCC
- Locally advanced or metastatic renal cell carcinoma Measurable disease by CT or MRI
- Karnofsky performance scale status of >=70
- Age >=18 years
- A female is eligible to enter and participate in this study if she is of: non-childbearing or agrees to use adequate contraception.
- Adequate organ system function
- Total serum calcium concentration <12.0mg/dL
- Left ventricular ejection fraction >= lower limit of institutional normal
Exclusion criteria:
- Pregnant or lactating female (unless agrees to refrain from nursing throughout the treatment period and for 14 days following the last dose of study)-History of another malignancy (unless have been disease-free for 3 years)
- History or clinical evidence of central nervous system (CNS) metastases (unless have previously-treated CNS metastases and meet all 3 of the following criteria are: are asymptomatic, have had no evidence of active CNS metastases for >=6 months prior to enrolment, and have no requirement for steroids or enzyme-inducing anticonvulsants)
- Clinically significant gastrointestinal abnormalities including, but not limited to: malabsorption syndrome, major resection of the stomach or small bowel that could affect the absorption of study drug, active peptic ulcer disease, known intraluminal metastatic lesion/s with suspected bleeding, Inflammatory bowel disease, ulcerative colitis, or other gastrointestinal conditions with increased risk of perforation, history of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment
- Presence of uncontrolled infection
- Prolongation of corrected QT interval (QTc) > 480 milliseconds
- History of any one or more of the following cardiovascular conditions within the past 12 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery by-pass graft surgery, symptomatic peripheral vascular disease, Class III or IV congestive heart failure, as defined by the New York Heart Association
- History of cerebrovascular accident including transient ischemic attack within the past 12 months
- History of pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months (unless had recent DVT and have been treated with therapeutic anti-coagulating agents for at least 6 weeks)
- Poorly controlled hypertension (defined as systolic blood pressure of >=150mmHg or diastolic blood pressure of >=90mmHg). Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry
- Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer.
- Evidence of active bleeding or bleeding susceptibility
- Spitting/coughing up blood within 6 weeks of first dose of study drug
- Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels
- Any serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with patient's safety, obtaining informed consent or compliance to the study
- Use any prohibited medications within 14 days of the first dose of study medication
- Use of an investigational agent, including an investigational anti-cancer agent, within 28 days or 5 half-lives, whichever is longer, prior to the first dose of study drug
- Prior use of an investigational or licensed drug that targets VEGF or VEGF receptors (eg. bevacizumab, sunitinib, sorafenib, etc), or are mTOR inhibitors (eg. temsirolimus, everolimus, etc).
- Is now undergoing and/or has undergone in the 14 days immediately prior to first dose of study drug, any cancer therapy (surgery, tumor embolization, chemotherapy, radiation therapy, immunotherapy, biological therapy, or hormonal therapy)
- Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity
- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib or sunitinib
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
No longer a GSK study
Actual primary completion date
2012-21-05
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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Access to clinical trial data by researchers
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