Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
GlaxoSmithKline |
---|---|
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00334282 |
To evaluate efficacy and safety of pazopanib compared to placebo in patients with locally advanced and/ or metastatic renal cell carcinoma (RCC). Approximately 350 eligible patients will be stratified and randomized in a 2:1 ratio to receive either 800mg pazopanib once daily or matching placebo. The study treatment will continue until patients experience disease progression, unacceptable toxicity or death. Primary objective of the study is to evaluate and compare the two treatment arms for progression-free survival. Principal secondary objective is to evaluate and compare the two treatment arms with respect to overall survival. Other objectives are overall response rate [complete response (CR) + partial response (PR)], rate of CR + PR + 6 months stable disease, and the incidence, severity and causality of adverse events and serious adverse events. Safety and efficacy assessments will be regularly performed on all patients. An Independent Data Monitoring Committee will be established to monitor safety during the course of the study and to evaluate interim efficacy data on overall survival.
Condition | Intervention | Phase |
---|---|---|
Renal Cell Carcinoma |
Drug: Pazopanib or placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomised, Double-Blind, Placebo Controlled, Multi-Center Phase III Study to Evaluate the Efficacy and Safety of Pazopanib (GW786034) Compared to Placebo in Patients With Locally Advanced and/ or Metastatic Renal Cell Carcinoma |
Enrollment: | 400 |
Study Start Date: | April 2006 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A patient will be considered for inclusion in this study only if all of the following criteria apply:
Note: If the metastatic disease is restricted to a solitary lesion, its neoplastic nature must be confirmed by histology or cytology. Cytology cannot be the only pathologic criteria to confirm clear cell RCC, but can be used in a patient with histologically confirmed clear cell RCC to confirm that metastatic disease is neoplastic in nature.
Note: Patient should be excluded if all baseline measurable lesions are within previously irradiated areas.
Note: A patient must complete all the baseline disease assessments in order to be eligible. Baseline head, chest, abdominal and pelvic CT or MRI scans must be performed within 2 weeks prior to the first dose of study medication; baseline bone scan must be performed within 3 weeks of the first dose of study medication.
Note: The first-line cytokine-based treatment can be interleukin-2 (IL-2) or interferon-α (INFα) monotherapy, IL-2 in combination with INF-α, IL-2 and/or INF-α in combination with chemotherapy, hormonal or other therapies excluding agents targeting angiogenesis pathways. Agents in a combination regimen can be given sequentially if the treatment sequence is pre-determined and the patient does not fail one agent prior to starting another.
Note: Prior adjuvant or neo-adjuvant therapies are permitted excluding any agents that target VEGF or VEGF receptors. The adjuvant/neo-adjuvant therapies should not be considered as first-line systemic treatment for advanced RCC.
Or,
Patients who have received no prior systemic therapy for advanced/metastatic RCC can be enrolled if under any of the following circumstances:
Patients who have recurred following prior adjuvant or neo-adjuvant cytokine therapy for RCC are eligible to participate without receiving a first-line systemic treatment for locally advanced or metastatic RCC. These patients should be stratified as the first-line population [see Section 4].
- Male or female ≥ 18 years of age.
- A woman is eligible to participate in the study if she is of:
Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who:
•Has had a hysterectomy,
Childbearing potential, has a negative serum pregnancy test within 2 weeks of the first dose of study medication, and agrees to use adequate contraception. GSK acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follows:
Oral contraceptives are not reliable due to the potential for drug-drug interactions.
A man with a female partner of childbearing potential is eligible to enter and participate in the study if he is abstinent or uses a barrier method of contraception during the study.
- ECOG PS 0 or 1
- Adequate baseline organ function defined as:
•Hematologic function: ANC ≥1 x 10^9/L Hemoglobin ≥ 9 g/dL Platelet ≥75 x 10^9/L
•Hepatic function: Total bilirubin ≥ 1.5 x ULN AST and ALT ≥ 2 x ULN
•Renal function: Calculated creatinine clearance≥30 mL/min [See Section 14.6 Appendix 6] and
≥Urine protein is 0, trace, or +1 determined by dipstick urinalysis, or < 1.0 gram determined by 24-hour urine protein analysis.
Note: A patient should first be screened with dipstick urinalysis. If urine protein is ≥2+, then a 24-hour urine protein must be assessed and patient will be excluded if 24-hour urine protein is≥ 1.0 gram.
•Corrected serum calcium level within normal range per local clinical laboratory standard.
Note: Patients with hypercalcemia should be treated until the corrected serum calcium level reaches the normal range.
Note: In patients with prior radiotherapy, the steroid doses should be stable or decreasing for at least 2 weeks.
Exclusion Criteria:
A patient will not be eligible for inclusion in this study if any of the following criteria apply:
- Pregnant or lactating female.
- History of another malignancy. Note: Patients who have had another malignancy and have been disease-free for 5 years, or patients with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible.
Note: A baseline brain CT or MRI scan must be obtained in all patients within 2 weeks of the first dose of study medication.
- Malabsorption syndrome or disease that significantly affects gastrointestinal function, or major resection of the stomach or small bowel that could affect the absorption of pazopanib.
History of any one of the following cardiac conditions within the past 6 months:
•Cardiac angioplasty or stenting, or
•Myocardial infarction, or
•Unstable angina.
Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. The blood pressure must be re-assessed on two occasions that are separated by a minimum of 24 hours. The mean SBP / DBP values from both blood pressure assessments must be < 140/90mmHg in order for a patient to be eligible for the study. See Section 6.1.1 and Section 6.1.3 for details on blood pressure control and re-assessment prior to randomization.
- History of untreated deep venous thrombosis (DVT) within the past 6 months (e.g. a calf vein thrombosis that is not treated).
Note: Patients with recent DVT who are treated with therapeutic anti-coagulating agents (excluding therapeutic warfarin) for at least 2 weeks are eligible.
- Presence of any non-healing wound, fracture, or ulcer, or presence of symptomatic peripheral vascular disease.
Other Eligibility Criteria Considerations To assess any potential impact on subject eligibility with regard to safety, the investigator must refer to the following document(s) for detailed information regarding warnings, precautions, contraindications, adverse events, and other significant data pertaining to the investigational product(s) being used in this study: Clinical Investigator's Brochure for pazopanib [GlaxoSmithKline Document Number RM2002/00017/03, 2005].
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | VEG105192 |
Study First Received: | June 5, 2006 |
Last Updated: | November 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00334282 |
Health Authority: | United States: Food and Drug Administration |
Metastatic Pazopanib GW786034 Anti-angiogenesis |
Urologic Diseases Kidney Neoplasms Carcinoma, Renal Cell Urogenital Neoplasms Renal cancer Kidney Diseases |
Kidney cancer Urologic Neoplasms Adenocarcinoma Urinary tract neoplasm Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type |