At a glance
ClinicalIndex Comparison Record- ✓Pathologically confirmed solid tumor of any type
- ✓Incurable cancer with documented progression after at least one prior therapy and no further standard treatment options available
- ✓At least one evaluable lesion measurable by RECIST criteria
- ✕Clinically unstable primary or metastatic CNS tumors
- ✕Known history of diabetes
- ✕QTc interval greater than 470 ms
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1 Study Of Pf-05212384 (Also Known As Pki-587) Administered As An Intravenous Infusion To Patients With Solid Tumors
In Brief
A Phase 1 clinical trial evaluating PF-05212384 (also known as PKI-587) for Neoplasms. Completed, enrolled 78 participants across 9 sites in 3 countries.
Detailed Summary
This is a two-part study of a compound called PF-05212384 (also known as PKI-587). The purpose of part 1 is to identify the Maximum Tolerated Dose (MTD) of PF-05212384 using a Continual Reassessment Method (CRM). Part 1 will include subjects with any solid tumor. In Part 2 two cohorts will be enrolled. One cohort will assess safety, tolerability and preliminary efficacy in 20 subjects at the MTD and will include subjects with breast cancer, ovarian cancer, endometrial cancer, colorectal cancer renal cancer or glioblastoma (a type of brain tumor). The other cohort will include 5 to 15 subjects with any type of tumor who consent to provide tumor biopsies while participating in the study.
Study Details
Timeline
Interventions
Intravenous dosing once weekly infusion