An Open-Label Extension Study to Assess the Safety and Efficacy of Pazopanib in Subjects with Renal Cell Carcinoma previously enrolled on Protocol VEG105192 . - ND
- Conditions
- Renal Cell CarcinomaMedDRA version: 9.1Level: LLTClassification code 10038415Term: Renal cell carcinoma stage unspecified
- Registration Number
- EUCTR2006-002381-18-IT
- Lead Sponsor
- GlaxoSmithKline R D Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 132
Specific information regarding warnings, precautions, contraindications, adverse events, and other pertinent information on the investigational product that may impact subject eligibility is provided in the CIB. Subjects eligible for enrolment in the study must meet all of the following criteria 1.Signed written informed consent. 2.Have been enrolled into study VEG105192 and have documented disease progression after being randomized into the placebo arm. 3.A woman is eligible to participate in the study if she is of a.Non-childbearing potential i.e., physiologically incapable of becoming pregnant , including any female who Has had a hysterectomy, Has had a bilateral oophorectomy ovariectomy , Has had a bilateral tubal ligation, Is post-menopausal total cessation of menses for 61619; 1 year . b.Childbearing potential, has a negative serum pregnancy test within 2 weeks of the first dose of pazopanib, 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 An intrauterine device with a documented failure rate of less than 1 per year. Vasectomized partner who is sterile prior to the female patient s entry and is the sole sexual partner for that female. Complete abstinence from sexual intercourse for 14 days before exposure to investigation product, through the clinical trial, and for at least 21 days after the last dose of investigational product. Double-barrier contraception condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm with spermicide . 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 uses a barrier method of contraception or is abstinent during the study. 4.ECOG PS 0, 1, 2 5.Adequate baseline organ function at the baseline visit defined as Hematologic function 61656;ANC 61619; 1 x 109/L 61656;Hemoglobin 61619; 9 g/dL 61656;Platelet 61619; 75 x 109/L Hepatic function 61656;Total bilirubin 61603; 1.5 x ULN 61656;AST and ALT 61603; 2 x ULN Renal function 61656;Calculated creatinine clearance 61619; 30 mL/min See Section 12.4 Appendix 4 and 61656;Urine protein is 0, trace, or 1 determined by dipstick urinalysis, or 1.0 gram determined by 24-hour urine protein analysis. Note A subject should first be screened with dipstick urinalysis. If urine protein is 61619; 2 , then a 24-hour urine protein must be assessed and subject will be excluded if 24-hour urine protein is 61619; 1.0 gram. Corrected serum calcium level within normal range per local clinical laboratory standard. Note Subjects with hypercalcemia should be treated until the corrected serum calcium level reaches the normal range. 6.At least 4 weeks must have elapsed since the last surgery and 2 weeks must have elapsed since radiotherapy. 7.Complete recovery from prior surgery, and/or reduction of all AEs to Grade 1 from prior systemic therapy or radiotherapy. Note In subjects with prior radiotherapy, the steroid doses should be stable or decreasing for at least 2 weeks.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
A subject will not be eligible for inclusion in this study if any of the following criteria apply 1.Has received any anti-cancer therapy since discontinuation of VEG105192. 2.Pregnant or lactating female. 3.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. 4.Symptomatic central nervous system CNS metastasis or leptomeningeal tumors. 5.Unable to swallow and retain orally administered medication. 6.Active peptic ulcer disease, 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 4 weeks prior to beginning study treatment. 7.History of human immunodeficiency virus infection. 8.Presence of uncontrolled infection. 9.Corrected QT interval QTc prolongation at baseline defined as QTc interval 470 msecs. 10.History of Class III or IV congestive heart failure according to New York Heart Association NYHA classification See Section 12.3 Appendix 3 for description . 11.History of any one of the following cardiac conditions within the past 6 months Cardiac angioplasty or stenting, or Myocardial infarction, or Unstable angina. 12.History of cerebrovascular accident or pulmonary embolus within the past 6 months. 13.Poorly controlled hypertension at baseline defined as systolic blood pressure SBP of 61619;140mmHg, or diastolic blood pressure DBP of 61619; 90mmHg . 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 subject to be eligible for the study. Section 7.1.1 for details on blood pressure control and re-assessment prior to treatment with pazopanib. 14.History of untreated deep venous thrombosis DVT within the past 6 months e.g. a calf vein thrombosis that is not treated . Note Subjects with recent DVT who are treated with therapeutic anti-coagulating agents excluding therapeutic warfarin for at least 6 weeks are eligible. 15.Presence of any non-healing wound, fracture, or ulcer, or presence of symptomatic peripheral vascular disease. 16.Evidence of bleeding diathesis or coagulopathy. 17.Any serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with subject s safety, obtaining informed consent or compliance to the study. 18.Has taken any prohibited medications that are listed in Section 6.10 within 14 days of the first dose of pazopanib.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): Safety of 800mg pazopanib administered to subject with renal cell carcinoma.;Main Objective: To evaluate the safety and tolerability of pazopanib 800mg QD for the treatment of renal cell carcinoma RCC ;Secondary Objective: To evaluate the respose rate CR PR in subjects treated with pazopanib 800mg; To evaluate CR PR 6 months stable disease SD in subjects treated with Pazopanib; To evaluate progression-free survival PFS in subject treated with Pazopanib; To evaluate overall survival OS in subjects treated with pazopanib 800mg.
- Secondary Outcome Measures
Name Time Method