A Phase II Study of Pazopanib in Patients With Imatinib Refractory or Intolerant Gastrointestinal Stromal Tumors (GIST)
This study is being done to gather information about the safety (any harmful effects) and effectiveness (usefulness) of Pazopanib in the treatment of Gastrointestinal Stroma Tumors (GIST) that cannot be treated by surgery or has spread to other organs. The Food and Drug Administration (FDA) have approved Pazopanib for the treatment of advanced kidney cancer but it is not approved for the treatment of GIST. The investigators hope to learn about the safety and usefulness (effectiveness) of Pazopanib for patients with GIST. Primary Objective: Non-progression rate based on RECIST criteria (CR+PR+SD) Secondary Objectives: - Response per Choi criteria - 6 month progression-free survival - Safety and tolerability
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : Pazopanib
Phase: Phase 2
Ages Eligible For Study:
- Metastatic or unresectable gastrointestinal stromal tumor (GIST) - Failure or intolerance to Imatinib and sunitinib - Subjects must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow up. - Procedures conducted as part of the subject's routine clinical management (e.g., blood count, imaging study) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol. - Age >= 18 years - Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 - Measurable disease criteria by RECIST criteria - Adequate organ system function as defined in protocol. - A female is eligible to enter and participate in this study if she is of non-childbearing potential (i.e., physiologically incapable of becoming pregnant). This includes any female who has had: - A hysterectomy - A bilateral oophorectomy (ovariectomy) - A bilateral tubal ligation - Menopause - Childbearing potential females must have a negative serum pregnancy test within 2 weeks prior to the first dose of study treatment, preferably as close to the first dose as possible, and agree to use adequate contraception. Adequate acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follow: - An intrauterine device with a documented failure rate of less than 1% per year. - Vasectomized partner who is sterile prior to the female subject?s entry and is the sole sexual partner for that female. - Complete abstinence from sexual intercourse for 14 days before exposure to investigational product, through the dosing period, 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 edify eligible disease(s)/stage(s)