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A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Pazopanib as Adjuvant Therapy for Subjects With Localized or Locally Advanced RCC Following Nephrectomy

Phase 3
18 Years
Open (Enrolling)

Thank you

Trial Information

A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Pazopanib as Adjuvant Therapy for Subjects With Localized or Locally Advanced RCC Following Nephrectomy

Inclusion Criteria:

- Signed written informed consent

- Diagnosis of RCC with clear-cell or predominant clear-cell histology

- Subjects with non-metastatic disease (M0) fulfilling any of the following
combinations of pathologic staging based on American Joint Committee on Cancer (AJCC)
TNM staging version 2010 and Fuhrman nuclear grading.

- pT2, G3 or G4, N0; or,

- pT3, G any, N0; or,

- pT4, G any, N0; or,

- pT any, G any, N1

- Fulfill all of the following criteria of disease-free status at baseline:

- Had complete gross surgical resection of all RCC via radical or partial
nephrectomy using either open or laparoscopic technique.

- Baseline imaging of chest, abdomen and pelvis shows no metastasis or residual
tumor lesions as confirmed centrally by an independent radiologist.

- Received no prior adjuvant or neo-adjuvant treatment for RCC

- Recovered from nephrectomy: any surgery related toxicities should be reduced to ≤
grade 1 per NCI Common Terminology Criteria for Adverse Events (CTCAE) (Version 4)

- Karnofsky performance scale (KPS) of ≥ 80

- Adequate organ system function

Exclusion Criteria:

- History of another malignancy. Exception: Subjects who have had another malignancy
and have been disease-free for 5 years, or subjects with a history of completely
resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma
are eligible

- Clinically significant gastrointestinal abnormalities that may increase the risk for
gastrointestinal bleeding including, but not limited to:

- Active peptic ulcer disease

- Inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease), 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

- Active diarrhea of any grade

- Clinically significant gastrointestinal abnormalities that may affect absorption of
investigational product including, but not limited to:

- Malabsorption syndrome

- Major resection of the stomach or small bowel

- History of human immunodeficiency virus (HIV) infection

- History of active hepatitis

- Presence of uncontrolled infection.

- History of any one or more of the following cardiovascular conditions within the past
6 months:

- Cardiac angioplasty or stenting

- Myocardial infarction

- Unstable angina

- Coronary artery bypass graft surgery

- Symptomatic peripheral vascular disease

- History of Class III or IV congestive heart failure, as defined by the New York Heart
Association Classification of Congestive Heart Failure

- History of cerebrovascular accident including transient ischemic attack (TIA),
pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6

- Corrected QT interval (QTc) > 480 milliseconds (msec)

- Poorly controlled hypertension, defined as systolic blood pressure (SBP) of ≥140 mmHg
or diastolic blood pressure (DBP) of ≥ 90mmHg.

Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to
study entry. Blood pressure (BP) must be re-assessed on two occasions that are separated
by a minimum of 1 hour; on each of these occasions, the mean (of 3 readings) SBP / DBP
values from each BP assessment must be <140/90 mmHg in order for a subject to be eligible
for the study (see Section 7.6.2 for instruction on blood pressure measurement and
obtaining mean blood pressure values).

- Evidence of active bleeding or bleeding diathesis

- Any serious and/or unstable pre-existing medical, psychiatric, or other condition
that could interfere with subject's safety, provision of informed consent, or
compliance to study procedures

- Unable or unwilling to discontinue use of prohibited medications for at least 14 days
or five half-lives of a drug (whichever is longer) prior to the first dose of study
treatment and for the duration of the study.

- Concurrent therapy given to treat cancer including treatment with an investigational
agent or concurrent participation in another clinical trial involving anti-cancer
investigational drug.

- Administration of an investigational drug within 30 days or 5 half-lives, whichever
is longer, preceding the first dose of study treatment.

- Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs
chemically related to pazopanib or excipients that in the opinion of the investigator
contraindicates their participation.

- Prior or current use of systemic anti-VEGF inhibitors, cytokines (e.g. interferon,
interleukin 2).

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Disease-free survival

Outcome Time Frame:

approximately 6 years

Safety Issue:


Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:



Canada: Health Products and Foods Branch, Health Canada

Study ID:




Start Date:

August 2001

Completion Date:

April 2017

Related Keywords:

  • Cancer
  • anti-angiogenic agent
  • renal cell carcinoma
  • pazopanib
  • adjuvant therapy
  • VEGFR inhibitor
  • Carcinoma, Renal Cell



GSK Investigational Site Little Rock, Arkansas  72205
GSK Investigational Site Bakersfield, California  93309
GSK Investigational Site Gainesville, Florida  32610
GSK Investigational Site Springfield, Massachusetts  01107
GSK Investigational Site Duluth, Minnesota  55805
GSK Investigational Site St. Louis, Missouri  63141
GSK Investigational Site Raleigh, North Carolina  27609
GSK Investigational Site Akron, Ohio  44304
GSK Investigational Site Fort Worth, Texas  76104
GSK Investigational Site Savannah, Georgia  31405
GSK Investigational Site Park Ridge, Illinois  60068
GSK Investigational Site Bettendorf, Iowa  52722
GSK Investigational Site Baltimore, Maryland  21201
GSK Investigational Site Royal Oak, Michigan  48073
GSK Investigational Site Pittsburgh, Pennsylvania  15213
GSK Investigational Site Germantown, Tennessee  38138
GSK Investigational Site Salem, Virginia  24153
GSK Investigational Site New York, New York  10021
GSK Investigational Site Washington, District of Columbia  20307-5001
GSK Investigational Site Omaha, Nebraska  68131
GSK Investigational Site Henderson, Nevada  89014
GSK Investigational Site Edison, New Jersey  08837
GSK Investigational Site Oregon City, Oregon  97045
GSK Investigational Site Cranston, Rhode Island  02920
GSK Investigational Site Seattle, Washington  98133