Skip to main content

8110 Gatehouse Road, Falls Church, VA 22042

A Phase 1 study to evaluate the safety, tolerability, pharmacogenetics and pharmacodynamics of PF-06939999 (PRMT5 inhibitor)

General Information

Age Group

Adult

Status

Recruiting

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
8081 Innovation Park Drive
Fairfax, VA 22031
A department of Inova Fairfax Hospital

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

Additional information can be found at https://clinicaltrials.gov/ct2/show/NCT03854227