A Phase 1 Study of PKI-587 in Subjects with Solid Tumours
Research type
Research Study
Full title
A Phase 1 Study of PKI-587 Administered as an Intravenous Infusion in Subjects with Solid Tumours
IRAS ID
29710
Contact name
James Spicer
Sponsor organisation
Pfizer Inc
Eudract number
2009-012379-85
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
Research summary
This research study involves subjects with solid tumours (cancer), which are not curable with currently available therapies. The main purpose of this study is to find the highest safe dose (also termed Maximum Tolerated Dose or MTD) of the experimental study drug, PKI-587, in patients with any type of solid tumour, and to determine how well PKI-587 works on treating certain types of cancer. Consecutive cohorts of subjects will receive PKI-587 administered once a week as an intravenous infusion.Safety and pharmacokinetic data (information about what the body does to the drug) will be obtained, and markers of efficacy (how well the drug works) will be assessed. Safety parameters will include medical and cancer history review, physical examinations, measurement of vital signs, ECGs (heart function tests) and laboratory evaluations. Clinical activity will be evaluated by performing tumour assessments (scans) periodically throughout the study.This study also involves genetic testing on tumour tissue samples to see if there are certain markers that might predict how to best treat a particular type of cancer. This is a 'first in man study' i.e. it is the first time PKI-587 will be given to humans.Subjects will sign an informed consent form before any tests or examinations are performed. Subjects will be asked to sign a separate informed consent form for the genetic testing part of the study, to indicate whether or not they agree for their tumour tissue samples to be used for this research. Each subject's suitability for the study will be assessed during a screening period. It is expected that subjects will be in this study for about 6 months, or for as long as they are tolerating the study drug and their cancer is not getting worse.
REC name
London - London Bridge Research Ethics Committee
REC reference
09/H0804/98
Date of REC Opinion
18 Dec 2009
REC opinion
Further Information Favourable Opinion