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 - VEG113387

ovartis Pharma Services AG0 sites1,500 target enrollmentAugust 26, 2010

Overview

No summary available.

Registry

who.int

Start Date

August 26, 2010

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

•1\. Signed written informed consent
•2\. Diagnosis of RCC with clear\-cell or predominant clear\-cell histology.
•3\. Subjects with non\-metastatic disease (M0\) fulfilling any of the following combinations of pathologic staging based on AJCC TNM staging version 2010 and Fuhrman nuclear grading \[see Section 12\.2 Appendix 2 and Section 12\.3 Appendix 3 for details].
•pT2, G3 or G4, N0; or,
•pT3, Gany, N0; or,
•pT4, Gany, N0; or,
•pTany, Gany, N1
•Note 1: Excisional biopsy is required of all regional lymph node(s) which appear abnormal on pre\-operative scans or at surgery.
•In order to properly stratify subjects (see Section 5\.5\), it is required that the investigator designate the nodal status as either N0 or N1 according to the following criteria which will be captured in the eCRF:
•N0 requires that a subject have no abnormal regional lymph nodes on preoperative scans or visualized at surgery, OR have regional lymph nodes biopsied with negative (no tumor present) result.

•Subjects meeting any of the following criteria must not be enrolled in the study:
•1\. Locally recurrent RCC, bilateral RCC, or 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.
•2\. 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
•3\. Active diarrhea of any grade
•4\. Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to:
•Malabsorption syndrome