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A Dose Escalation Study Evaluating CPI-818 in Relapsed/Refractory T-Cell Lymphoma
Recruiting
I'm InterestedTrial ID: NCT03952078
Purpose
This is a Phase 1/1b, open-label, first in human study of CPI-818, an oral
interleukin-2-inducible tyrosine kinase (ITK) inhibitor for the treatment of
relapsed/refractory (R/R) T-cell lymphoma.. This trial will study the safety, tolerability,
and anti-tumor activity of CPI-818 as a single drug.
Official Title
A Phase 1/1b Dose-Escalation Trial Evaluating CPI-818, an Oral Interleukin-2-Inducible T-Cell Kinase Inhibitor, in Subjects With Relapsed/Refractory T-Cell Lymphoma
Stanford Investigator(s)
Youn H Kim, MD
The Joanne and Peter Haas, Jr., Professor for Cutaneous Lymphoma Research and Professor, by courtesy, of Medicine (Oncology)
Eligibility
Inclusion Criteria:
- Adult subjects age ≥18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Histologically confirmed evidence of T-cell lymphoma
- Measurable disease.
- Adequate organ function.
- At least 2 standard therapies for advanced or recurrent disease or had a disease for
which there is no more than one established therapy.
Exclusion Criteria:
- Treatment with systemic immunosuppressive medication.
- History of allogeneic hematopoietic stem cell transplantation.
- History of primary immunodeficiency, solid organ transplantation.
- History of opportunistic infection within 180 days of starting study drug.
- Females who are pregnant, lactating, or intend to become pregnant
- History of invasive prior malignancy that required systemic therapy within last 3
years.
- Concomitant use of strong inhibitors or inducers of CYP3A.
Intervention(s):
drug: CPI-818
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Elle Kim
650-387-4436