A Study to Evaluate Pazopanib as an Adjuvant Treatment for Localized Renal Cell Carcinoma (RCC)



Status:Active, not recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:7/14/2017
Start Date:November 30, 2010
End Date:April 15, 2019

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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

This randomized Phase III study is to evaluate whether pazopanib compared with placebo can
prevent or delay recurrence of kidney cancer in patients with moderately high or high risk of
developing recurrence after undergoing kidney cancer surgery


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 months.

- 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).
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Albany, New York 12208
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