A Continuation Study Using Sunitinib Malate For Patients Leaving Treatment On A Previous Sunitinib Study.
- Conditions
- C64-C50 Malignant neoplasm of breast-C25 Malignant neoplasm of pancreas-C16 Malignant neoplasm of stomach-C64 Malignant neoplasm of kidney, except renal pelvisMalignant neoplasm of stomachMalignant neoplasm of pancreasMalignant neoplasm of breastMalignant neoplasm of kidney, except renal pelvisC16C25C50
- Registration Number
- PER-091-08
- Lead Sponsor
- PFIZER S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Female
- Target Recruitment
- 0
• Subjects must have participated in a previous baseline study with sunitinib sponsored by Pfizer Worldwide Medical (as specified below) and, at the discretion of the baseline investigator, have the potential to benefit clinically from continued treatment with sunitinib.
• Subjects of Protocol A6181107 randomized to sunitinib who have completed treatment in the trial and who have demonstrated clinical benefit.
• Subjects of Protocol A6181107 randomized to capecitabine whose disease progressed with capecitabine during the study.
• Subjects of Protocol A6181108 who have completed 2 years of treatment with sunitinib / exemestane and who have demonstrated clinical benefit.
• Subjects of Protocol A6181110 who have completed one year of treatment with sunitinib and who have demonstrated clinical benefit.
• Subjects of Protocol A6181111 randomized to placebo whose disease progressed with placebo during the study.
• Subjects of Protocol A618111I randomized to either sunitinib or placebo, have completed the entire treatment period of the study and have demonstrated clinical benefit (patients treated with sunitinib) or their disease is stable (placebo patients) at the end of the trial.
• Subjects of Protocol A6181112 randomized to sunitinib who have completed the study and who have demonstrated clinical benefit.
• ECOG performance scale O, 1 or 2.
• Able to ingest an oral compound.
• Adequate organ function defined by the following criteria in your last visit of the previous base protocol, or in the first visit of this study. Serum aspartate aininotransferase (AST, serum glutamic-oxaloacetic transferase [SGOT]) and serum alanine aminotransferase (ALT, serum pyruvate-glutamate transferase [SOPT]) <2.5 x the upper normal limit (LNS). If liver function abnormalities are due to background disease, then AST and ALT may be <5 x LNS.
• Subjects must be enrolled as soon as possible after their End of Treatment / Withdrawal visit in the previous baseline study, but in all cases up to 4 weeks after this visit.
• Signed and dated informed consent document indicating that the subject (or legally acceptable representative) has been informed about all aspects pertinent to the trial prior to enrollment.
• Disposition and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.
• Man or woman 18 years of age or older.
• Current treatment in another clinical research trial.
• Concurrent treatment with another anti-cancer drug except treatment with exemestane as specified in this protocol.
• Evidence of neurological signs / symptoms secondary to brain metastasis, compression of the spine or new evidence of brain or leptomeningeal disease.
• Diagnosis of any other malignant disease within the last 5 years with the exception of basal or squamous cell carcinoma of adequately treated skin, or carcinoma in situ in the cervix.
• Any of the following within the 12 months prior to the administration of the study drug: myocardial infarction, severe / unstable angina, coronary / peripheral artery bypass graft, symptomatic congestive heart failure, stroke or transient ischemic attack , pulmonary embolism, deep vein thrombosis or other thromboembolic event.
• Treatment with potent inhibitors and inducers of CYP3A4 up to 7 and 12 days, respectively, before administration of the study drug. Inhibitors and potent inducers of CYP3A4 will not be allowed as concomitant medications during the study.
• Current treatment with therapeutic doses of anticoagulants (a low dose of coumadin up to 2 mg VO daily is allowed for the prophylaxis of deep vein thrombosis).
• Hypertension that can not be controlled by medications (> 150/100 mmHg despite optimal medical therapy).
• Pre-existing thyroid abnormality with thyroid function that can not be maintained within the normal range with medication.
• Human immunodeficiency virus (HIV) positive or disease related to acquired immunodeficiency syndrome (AIDS).
• Pregnancy or breastfeeding. Subjects must be surgically sterile or post-menopausal, or must agree to use an effective method of contraception during the therapy period. All female subjects with reproductive potential must have a negative pregnancy test (serum or urine) within 7 days of enrollment. Male subjects must be surgically sterile or must agree to use an effective method of contraception during the therapy period. The definition of effective contraception will be based on the criteria of the principal investigator or a designated physician.
• Another severe chronic or acute medical or psychiatric condition or abnormal laboratory values that may increase the risk associated with study participation or the administration of the study drug, or may interfere with the interpretation of the study results, and that The investigator´s criterion would make the entry of this patient into the study inappropriate.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Assessment of AEs included type, incidence, severity (graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], Version 3.0, timing, seriousness, and relatedness; and laboratory abnormalities.<br><br>Measure:Number of Participants With Treatment-emergent Adverse Events (AEs) (All Causalities)<br>Timepoints:From first day of treatment on the current study up to 28 days post the last dose of study treatment<br>
- Secondary Outcome Measures
Name Time Method