Spots Global Cancer Trial Database for Study of PKI-179 Administered Orally to Subjects With Solid Tumors
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Trial Identification
Brief Title: Study of PKI-179 Administered Orally to Subjects With Solid Tumors
Official Title: A Phase 1 Study of PKI-179 Administered Orally to Subjects With Solid Tumors
Study ID: NCT00997360
Conditions
Interventions
Study Description
Brief Summary: This is an open label dose escalation study to find the maximum tolerated dose (MTD) of PKI-179 in subjects with solid tumors. Part 1 of the study will be the dose estimation phase and will be open to subjects with all solid tumors. Part 2 will be the dose confirmation phase and will be open to subjects with breast, non small cell lung, ovarian, endometrial, or colorectal cancer or glioblastoma. All subjects will receive daily oral dosing of PKI-179. A continuous reassessment method (CRM) design will be used, which will take into account dose limiting toxicity (DLT) information from each dose level explored in order to determine the next dose level.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Contact Details
Name: Medical Monitor
Affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
Role: STUDY_DIRECTOR
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