A Study To Evaluate The Effect Of Itraconazole On Pharmacokinetics Of PF-06463922 In Healthy Volunteers
Completed
Pfizer
Phase 1
2016-08-16
The purpose of this study is to estimate the effect of itraconazole on the single dose
pharmacokinetics of PF-06463922 in healthy volunteers in the fasted state.
This is a prospective, non-randomized clinical trial that aims to describe the efficacy and
toxicity of commercially available, targeted anticancer drugs* prescribed for treatment of
patients with advanced cancer with a potentially actionable variant as revealed by a genomic
or protein expression test. The study also aims to simplify patient access to approved
targeted therapies that are contributed to the program by collaborating pharmaceutical
companies and to perform next generation sequencing on tumor biopsies for biomarker analyses.
Eligible patients have an advanced solid tumor, multiple myeloma or B cell non-Hodgkin
lymphoma for which standard treatment options are no longer available and acceptable
performance status and organ function. A genomic or protein expression test must have been
performed on the tumor and the results must identify at least one potentially actionable
molecular variant as defined in the protocol. Results from the molecular profiling test will
be used to determine an appropriate drug(s) from among those available in the protocol. The
choice of drug will be supported by a list of potential profiles, a molecular tumor board, a
knowledge library and by study coordinators for review and approval of the match. The
protocol-specified treatment will be administered to the patient once any drug-specific
eligibility criteria are confirmed and a fresh pre-treatment biopsy is performed for future
genetic studies. All patients who receive treatment with a drug available in the protocol
will be followed for standard efficacy outcomes including tumor response, progression-free
and overall survival as well as duration of treatment. In addition, treatment related
toxicity will be evaluated.
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