NCT00997360

Study of PKI-179 Administered Orally to Subjects With Solid Tumors

A Phase 1 Study of PKI-179 Administered Orally to Subjects With Solid Tumors

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Malignant Solid Tumors

Interventions

Type	Name	Description
DRUG	PKI-179

Timeline

• Start date: 2010-02-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2009-10-19
• Last updated: 2018-09-27