A Study Of PF-06647263 In Patients With Advanced Solid Tumors

Status:	Active, not recruiting
Conditions:	Breast Cancer, Ovarian Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	5/24/2017
Start Date:	April 2014
End Date:	May 2017

A First-in-human Phase 1, Dose Escalation, Safety And Pharmacokinetic Study Of Pf-06647263 In Adult Patients With Advanced Solid Tumors

To assess the safety and tolerability at increasing dose levels of PF-06647263 in patients
with advanced solid tumors in order to determine the maximum tolerated dose and select the
recommended Phase 2 dose.

The clinical study will include 2 parts. Part 1 will estimate the MTD in dose escalation
cohorts in patients with advanced solid tumors for whom no standard therapy is available in
order to establish the RP2D. Part 2 will include patients with previously treated metastatic
triple negative breast cancer (TNBC).

Inclusion Criteria:

- Diagnosis of solid tumor that is advanced/metastatic and resistant to standard
therapy or for whom no standard therapy is available

- Performance Status of 0 or 1

- Adequate bone marrow, kidney, and liver function

- Part 2 includes advanced triple negative breast cancer patients.

Exclusion Criteria:

- Brain metastases requiring steroids

- Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of
study treatment start

- Active and clinically significant bacterial, fungal or viral infection

We found this trial at

sites

University of Texas M.D. Anderson Cancer Center

1515 Holcombe Blvd
Houston, Texas 77030

713-792-2121