A Dose Escalation Study of PF-06650808 in Patients With Advanced Solid Tumors
Conditions
Neoplasms - Breast Cancer
Conditions: Keywords
solid tumors, triple negative breast cancer, PF-06650808, Phase 1
Study Type
Interventional
Study Phase
Phase 1
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: PF-06650808 Type: Drug
Name: PF-06650808 Type: Drug
Overall Status
Recruiting
Summary
To assess the safety and tolerability at increasing dose levels of PF-06650808 in patients with advanced solid tumors in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

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

- Previously treated metastatic triple negative breast cancer that expresses Notch3 with at least one measurable lesion

- Adequate bone marrow, renal and liver function

Exclusion Criteria:

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

- Patients with known symptomatic brain metastases requiring steroids

- Prior treatment with a compound of the same mechanism
Locations
Administrative Address: UCLA Hematology/Oncology
Los Angeles, California, United States
Status: Recruiting
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
Status: Recruiting
Ronald Reagan UCLA Medical Center, Drug Information Center
Los Angeles, California, United States
Status: Recruiting
Westwood Bowyer Clinic
Los Angeles, California, United States
Status: Recruiting
Santa Monica - UCLA Medical Center & Orthopaedic Hospital
Santa Monica, California, United States
Status: Recruiting
UCLA Hematology/Oncology - Santa Monica
Santa Monica, California, United States
Status: Recruiting
The Ohio State University James Cancer Hospital
Columbus, Ohio, United States
Status: Recruiting
The Ohio State University Martha Morehouse Medical Plaza
Columbus, Ohio, United States
Status: Recruiting
The OSU Investigational Drug Services: Drug Shipment Only
Columbus, Ohio, United States
Status: Recruiting
The OSU Stephanie Spielman Comprehensive Breast Center
Columbus, Ohio, United States
Status: Recruiting
South Texas Accelerated Research Therapeutics, LLC (START)
San Antonio, Texas, United States
Status: Recruiting
Start Date
June 2014
Completion Date
September 2016
Sponsors
Pfizer
Source
Pfizer
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page