CRC 12110: A Phase I/II, Multi-Center, Open-Label, Dose Escalation Trial of the Safety and Pharmacokinetics of Intravenous PR610 Given Weekly in Subjects with Solid Tumors

Type of Study
Cancer (Oncology) - Lung
Location
Swedish Cancer Institute
Short Description

Purpose: The purpose of this study is to determine the Maximum Tolerated Dose and the Dose-Limiting Toxicity of the drug to further evaluate safety and antitumor activity.

Status
Open to Enrollment
Principal Investigator
Howard (Jack) West, M.D.
Eligibility Notes

• Stage IIIB to IV, non-squamous, non-small cell lung cancer (NSCLC) with known sensitizing mutations in EGFR, and the T790M resistance mutation
• Histologically-confirmed, progressive, locally advanced or metastatic solid tumor
• Failed, refused, or not eligible for standard of care therapy
• ECOG performance status of 0, 1, or 2
• No clinically significant abnormal 12-lead ECG with QTcF >450 msec
• No use of any medications known to produce QT prolongation
• No family history of Long QT Syndrome
• No prior treatment with anthracyclines with a cumulative dose of doxorubicin (or equivalent) ≥400 mg/m2
• No cardiac left ventricular function with resting ejection fraction of less than 50%
• No prior therapy with an irreversible EGFR inhibitor
• No prior history of an allergic reaction to a tyrosine kinase inhibitor
• No other malignancy likely to effect the assessment of toxicity or efficacy of PR610

More Info Link
Additional information about the study summary and eligibility criteria may be viewed on the U.S. National Institutes of Health (NIH) website.
Phone
(206) 215-3086
Email
CancerResearch@swedish.org
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