Status:
COMPLETED
Study Evaluating SKI-606 in Subject With Solid Tumors
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Tumors
Eligibility:
All Genders
20-74 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of oral SKI-606 (100, 200, 300 or 400 mg) administered on a daily schedule to subjects with advanced malignant solid tumors and to ...
Eligibility Criteria
Inclusion
- Advanced or recurrent solid malignancy confirmed histologically or cytologically for which no effective therapy is available
- Recovery from acute adverse effects of prior therapies to £ Grade 1 (excluding alopecia)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1
- Adequate hepatic, renal, and bone marrow function
- Age 20 to 74 years
- Willingness of male and female subjects, who are not surgically sterile or postmenopausal, to use reliable methods of birth control for the duration of the study and for 6 months and 30 days after the last dose of test article for male and female, respectively
- Life expectancy of at least 12 weeks
Exclusion
- Use of any systemic antitumor agents or any investigational agent within 28 days before the enrollment (42 days if the previous chemotherapy included nitrosoureas or mitomycin C)
- Ongoing clinical requirement for administration of a strong inhibitor of CYP3A4
- Prior exposure to SKI-606 or any other Src-kinase inhibitor
- Major surgery or radiotherapy within 2 weeks before the enrollment (recovery from previous surgery should be complete before day 1)
- Subjects unable or unwilling to swallow SKI-606 capsules
- Active central nervous system (CNS) metastases, as indicated by clinical symptoms, cerebral edema, requirement for corticosteroids and/or progressive growth
- Recent or ongoing clinically-significant gastrointestinal disorder
- Pregnant or breastfeeding women
- Subjects who meet the following criteria:
- Evidence of serious active infection, significant medical or psychiatric illness
- History of unexplained syncope or known ventricular arrythmia
- Known seropositivity to HIV, or current or chronic Hepatitis B or Hepatitis hepatitis C
- Hypokalemia
- Unstable concurrent medical conditions
- Any other condition that, in the investigator's judgment, make the subject inappropriate for this study the subject inappropriate for this study
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01001936
Start Date
February 1 2006
End Date
December 1 2008
Last Update
October 27 2009
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