Last updated: 11/03/2018 14:57:45
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 GSK Clinical Study Register is no longer maintained for this study.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.
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 nephrectomyPROTECT
GSK study ID
113387
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Trial overview
Official title: 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
Trial description: 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
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Disease-free survival
Timeframe: approximately 6 years
Secondary outcomes:
Safety (frequency and severity of adverse events and laboratory abnormalities)
Timeframe: approximately 12 months
Overall survival
Timeframe: approximately 9 years
Health Outcome (change from baseline in patients' self-reports on health outcome and quality of life as measured by two instruments: Cancer Therapy-Kidney Symptom Index-19 and EuroQOL-5D
Timeframe: approximately 6 years
Disease-free survival rates at yearly time points (e.g. 1 year, 2 years, etc.).
Timeframe: yearly for 4 or 5 years
Interventions:
Enrollment:
1500
Primary completion date:
2015-15-10
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Cancer, Neoplasms
Product
pazopanib
Collaborators
Not applicable
Study date(s)
November 2010 to April 2019
Type
Interventional
Phase
2/3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
none
- Signed written informed consent
- Diagnosis of RCC with clear-cell or predominant clear-cell histology
- 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
Inclusion and exclusion criteria
Inclusion criteria:
- Signed written informed consent
- Diagnosis of RCC with clear-cell or predominant clear-cell histology
- pT2, G3 or G4, N0; or,
- pT3, G any, N0; or,
- pT4, G any, N0; or,
- pT any, G any, N1
- 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
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.
Fulfill all of the following criteria of disease-free status at baseline:
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
- 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
- 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.
- 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).
Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:
Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to:
History of any one or more of the following cardiovascular conditions within the past 6 months:
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
No longer a GSK study
Actual primary completion date
2015-15-10
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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