Study of PF-05212384 (Also Known as PKI-587)Administered Intravenously To Subjects With Solid Tumors

Completed · Phase 1

Conditions studied: Neoplasms

In brief

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.

Key facts

Study ID

NCT00940498

Run by

Pfizer

People needed

78

Starts

2010-01-01

Expected to finish

2012-10-01

Last updated by the study team

2018-11-02

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pathologic diagnosis of any solid tumor
• Incurable cancer, with disease progression following at least 1 therapy with no further standard treatment available in the opinion of the investigator.
• At least 1 evaluable lesion per RECIST criteria

You may not qualify if…

• Clinically unstable primary or metastatic CNS tumors
• Subjects with known diabetes
• QTc interval greater than 470 ms.

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana-Farber Cancer Insitute — Boston, Massachusetts, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• Sarah Cannon Research Institute, Tennessee Oncology, PLLC — Nashville, Tennessee, United States
• Hospital General Vall D'Hebron — Barcelona, Spain
• King's College London — London, England, United Kingdom

Full record on ClinicalTrials.gov

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