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Gynecologic
General Information
Study Name:
A Phase 1 study to evaluate the safety, tolerability, pharmacogenetics and pharmacodynamics of PF-06939999 (PRMT5 inhibitor)
Age Group:
Adult
Protocol Number:
NCT03854227
Background Information:
The purpose of this study is to learn about the effects of the study drug PF-06939999 and to find the best dose for treating your cancer.
Offered at:
Inova Schar Cancer Institute
3289 Woodburn Road Suite 320
Annandale, VA 22003
Eligibility Information
Participants must be 18 years of age or older
Histological or cytological diagnosis of a solid tumor that is advanced/metastatic, participants are intolerant to standard treatment or resistant to standard therapy
Participants must have at least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1, Section 10.11) that has not been previously irradiated
Adequate bone marrow, renal, and liver function
Additional eligibility in protocol
Ineligibility Information
Known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth
Participants with any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.
Major surgery within 4 weeks prior to study entry.
Radiation therapy within 4 weeks prior to study entry.
Systemic anti-cancer therapy within 4 weeks prior to study entry (6 weeks for mitomycin C or nitrosoureas)
Participants with active, uncontrolled bacterial, fungal, or viral infection, including hepatitis B virus (HBV), hepatitis C virus (HCV), known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness. HIV seropositive subjects who are healthy and low-risk for AIDS-related outcomes could be considered eligible
Additional exclusions in protocol
Contact Information
Contact Name:
Catherine D'Reaux, RN, BSN, OCN
Contact Phone:
703-208-6630
Contact Email:
catherine.dreaux@inova.org
Additional information can be found at
https://clinicaltrials.gov/ct2/show/NCT03854227?term=c3851001&rank=1