Phase II Study of PT-112 for Adults with Relapsed or Refractory Thymoma and Thymic Carcinoma

What this Trial Is About

Researchers are studying PT-112 as a treatment for people with recurrent thymoma or thymic carcinoma, cancers for which no approved drugs currently exist. This trial aims to evaluate whether PT-112 can shrink tumors in participants who have progressed after at least one platinum-based chemotherapy or who have refused standard chemotherapy. The study is a phase II, open-label trial designed to assess the drugs clinical activity and safety. Participants receive PT-112 through an intravenous infusion in 28-day cycles. During the first cycle, the drug is given on days 1 and 15 at a dose of 360 mgm2, followed by a dose of 250 mgm2 on day 1 of each subsequent cycle. Dose reductions are allowed if intolerable side effects occur. Treatment continues until disease progression, unacceptable side effects, or for up to 8 years. Optional tumor biopsies may be performed on days 1 of cycles 1 and 3. During the study, participants undergo physical exams, blood and urine tests, and ECGs on days they receive the drug. Imaging scans are done every 8 weeks to assess tumor response. After stopping therapy, follow-up visits occur at 2 and 4 weeks, then every 3 months for up to 8 years. Researchers measure overall response rate, survival, progression-free survival, duration of response, and safety throughout the trial.

PT-112 in Subjects With Thymoma and Thymic Carcinoma