An Open-Label, Phase 2 Study of PTX-100 Monotherapy in Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma.
Prescient Therapeutics, Ltd.
Summary
This is an open-label, phase 2 randomized study to evaluate the efficacy, safety, pharmacokinetics (PK) and pharmadynamics (PD), of PTX-100 monotherapy at 500 or 1000 mg/m2 in patients with relapsed/refractory Cutaneous T-Cell Lymphoma (CTCL). PTX-100 will be administered by IV infusion over 60 minutes on days 1 to 5 of a 14-day cycle for 4 cycles, then 21 day cycle thereafter. Subjects will be treated or followed up, if subjects discontinue treatment, for up to 18 months.
Description
PTX-100 from a Phase I study shown to help some CTCL patients. This Phase II study will be conducted in a larger population size and there will be initially two groups/arms in the first phase called Phase 2a. This phase will randomize and enroll 20 subjects into the 500 mg/m2 and 20 subjects into the 1000 mg/m2 PTX treatment arms. After determining the recommended optimal dose from phase 2a, for Phase 2b, 75 subjects will then be allocated into this single arm part of the study. Once subject has signed the informed consent, subject will undergo a 28 day screening period, where eligibility wou…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Adult patient ≥18 years of age at the time of signing the informed consent. 2. Patient is capable of giving adequate signed informed consent 3. Have a confirmed diagnosis of CTCL with histological confirmation 4. Patients must have greater than or equal to Stage Ib disease. 5. Has received and failed (or intolerant of) at least 2 prior lines of prior systemic therapy for their disease. 6. Has measurable disease defined by at least one of the following, within 28 days prior to start of study treatment: by evaluable by mSWAT or quantifiable by flow cytometry or morphology…
Interventions
- DrugPTX-100
Peptidomimetic inhibitor of GGTase 1
Locations (15)
- City of Hope Comprehensive Cancer CenteDuarte, California
- University of California IrvineIrvine, California
- Yale Cancer CenterNew Haven, Connecticut
- Dana-Farber Cancer InstituteBoston, Massachusetts
- Rochester Skin Lymphoma Medical Group. PLLCRochester, New York
- Virginia Commonwealth University Massey Comprehensive Cancer CenteRichmond, Virginia