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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

Phase 2
18 Years
Open (Enrolling)
Carcinoma, Renal Cell

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Trial Information

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

The study is designed to evaluate efficacy and safety of pazopanib versus sunitinib for the
treatment of Asian subjects with locally advanced and/or metastatic renal cell carcinoma
(RCC) enrolled from selected Far-East Asian countries. The primary objective is to evaluate
the primary endpoint progression free survival in the enrolled Asian subjects treated with
pazopanib versus those treated with sunitinib. The secondary objectives are to evaluate the
following secondary endpoints in each treatment arm: objective response rate, duration of
response, time to response, overall survival and safety. Subjects will be randomized in a
1:1 ratio to receive either 800mg pazopanib to be administered once daily orally continuous
dosing or 50mg sunitinib to be administered in 6-week cycles: 50mg orally daily for 4 weeks
followed by 2 weeks off treatment. Subjects are permitted to receive supportive care
throughout the study including transfusion of blood and blood products, treatment with
antibiotics, anti-emetics, anti-diarrheal agents, analgesics, erythropoietin, or
bisphosphonates, when appropriate. The study treatment will continue until subjects
experience disease progression, unacceptable toxicity, withdraw consent, or death.

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free Survival (PFS)

Outcome Description:

PFS is defined as the interval between the date of randomization and the earliest date of progressive disease (PD), as defined by the Independent Review Committee (IRC), or death due to any cause. The IRC defined PD per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1. Per RECIST, PD is defined as a >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter (LD) recorded since the treatment started or the appearance of >=1 new lesion. Participants who had neither progressed nor died were censored at the date of the last adequate tumor assessment at the time of the cut-off.

Outcome Time Frame:

From randomization to the earliest date of disease progression or death (up to 39 months)

Safety Issue:


Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:



Taiwan: Department of Health

Study ID:




Start Date:

May 2010

Completion Date:

December 2014

Related Keywords:

  • Carcinoma, Renal Cell
  • GW76034
  • Sunitinib
  • Renal cell carcinoma
  • Pazopanib
  • Carcinoma
  • Carcinoma, Renal Cell