Overview

This trial is active, not recruiting.

Condition carcinoma, renal cell
Treatments pazopanib, sunitinib
Phase phase 3
Targets VEGF, FLT-3, KIT, PDGF
Sponsor GlaxoSmithKline
Start date August 2008
End date May 2012
Trial size 927 participants
Trial identifier NCT00720941, 108844

Summary

This study is being conducted to provide a direct comparison of the efficacy, safety and tolerability for pazopanib and sunitinib (SUTENT)

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Control arm
sunitinib
50 mg sunitinib to be administered in 6-week cycles: 50mg orally daily for 4 weeks followed by 2 weeks off treatment
(Experimental)
Experimental arm
pazopanib
800 mg administered once daily orally continuous dosing

Primary Outcomes

Measure
Progression-free Survival (PFS)
time frame: From randomization until the earliest date of disease progression or death (up to Study Week 191)

Secondary Outcomes

Measure
Overall Survival
time frame: From randomization until death (up to Study Week 268)
Number of Participants in the Indicated Categories for Overall Response as Assessed by Independent Review
time frame: From randomization until the time of a confirmed best response of CR or PR (up to Study Week 167)
Time to Response
time frame: From randomization until the time of the first documented confirmed complete or partial response (up to Study Week 167)
Duration of Response (DOR)
time frame: From the time of the first documented confirmed complete or partial response until disease progression or death, if sooner (up to Study Week 167)
Number of Participants (Par.) With Serious Adverse Events (SAEs)/Non-serious Adverse Events (Any Untoward Medical Occurrence in a Par. Administered a Pharmaceutical Product and Which Does Not Necessarily Have a Causal Relationship With This Treatment)
time frame: From the time of the first dose of study drug to approximately one month after the discontinuation of study drug (up to Study Week 268)
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale Scores at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)
time frame: Baseline (predose); Weeks 4, 10, 16, and 22
Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Disease-related Symptoms-physical (DRS-P) Domain Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)
time frame: Baseline; Weeks 4, 10, 16, and 22
Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Disease Related Symptoms-emotional (DRS-E) Domain Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)
time frame: Baseline; Weeks 4, 10, 16, and 22
Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Treatment Side Effects (TSE) Domain Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)
time frame: Baseline; Weeks 4, 10, 16, and 22
Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Functional Well Being (FWB) Domain Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)
time frame: Baseline; Weeks 4, 10, 16, and 22
Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Total Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)
time frame: Baseline; Weeks 4, 10, 16, and 22
Change From Baseline in the Supplementary Quality of Life Questions (SQLQ) Scale Worst Soreness Scores at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)
time frame: Baseline; Weeks 4, 10, 16, and 22
Change From Baseline in the Supplementary Quality of Life Questions (SQLQ) Limitations Due to Mouth and Throat Soreness Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)
time frame: Baseline; Weeks 4, 10, 16, and 22
Change From Baseline in the Supplementary Quality of Life Questions (SQLQ) Limitations Due to Foot Soreness Scores at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)
time frame: Baseline; Weeks 4, 10, 16, and 22
Summary of Analysis for the Cancer Treatment Satisfaction Questionnaire (CTSQ) Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)
time frame: Weeks 4, 10, 16, and 22
Medical Resource Utilization (MRU): Assessed as the Mean Number of Non-study Medical Visits, Telephone Consultations, Hospital Days, and Emergency Room (ER) Visits Per 30 Days Through Week 24
time frame: From Day 1 up to Week 24
MRU: The Mean Number of Laboratory Visits, Radiology Visits, Home Healthcare Visits, and Medical Procedures for Cycles 1-4. MRU Data Collected at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)
time frame: Weeks 4, 10, 16, and 22

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Study VEG108844, A Study of Pazopanib Versus Sunitinib in the Treatment of Subjects With Locally Advanced and/or Metastatic Renal Cell Carcinoma
Description This study will evaluate the efficacy and safety of pazopanib compared to sunitinib in subjects with advanced RCC who have received no prior systemic therapy for advanced or metastatic RCC. 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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by GlaxoSmithKline.