A Phase 2 Study of PTX 100 in Patients With Relapsed/Refractory CTCL
ConditionCTCL
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPrescient Therapeutics, Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
Adult patient ≥18 years of age at the time of signing the informed consent.
Patient is capable of giving adequate signed informed consent
Have a confirmed diagnosis of CTCL with histological confirmation
Patients must have greater than or equal to Stage Ib disease.
Disqualifiers
Patients with known central nervous system involvement.
Patients who require the use of strong inhibitors or inducers of CYP enzymes or transporters (e.g., CYP3A4, 2D6, 2C19) or (P-gp, BCRP, OATP1B1, OATP1B3, OAT1. OAT3, OCT2, MATE1 and MATE2-K). Patients who are receiving these medications at Screening can be enrolled into the trial if they discontinue them for at least 14 days or 5 half-lives, whichever is longer, before they commence PTX-100. An alternative pharmacological treatment should be instituted by the treating clinician based on clinical judgement.
Significant cardiovascular disease. A history of, or concurrent interstitial lung disease or severely impaired lung function.
Trial design
Treatments tested in this trial
- PTX-100
Treatment groups
115 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov