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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05104736
Other study ID # 10000317
Secondary ID 000317-C
Status Recruiting
Phase Phase 2
First received
Last updated
Start date April 6, 2022
Est. completion date June 30, 2025

Study information

Verified date June 13, 2024
Source National Institutes of Health Clinical Center (CC)
Contact Shannon G Swift, R.N.
Phone (240) 858-3157
Email shannon.swift@nih.gov
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Background: There are no approved drugs to treat recurrent thymoma and thymic carcinoma. New therapies are needed for people with these cancers. Researchers want to see if the drug PT-112 can help. PT-112 kills cancer cells. It also helps the body s immune system fight cancer. Objective: To see if the study drug PT-112 can cause tumors to shrink. Eligibility: People ages 18 and older who have thymoma or thymic cancer and whose disease returned or progressed after treatment with at least one platinum-containing chemotherapy, or who have refused standard treatment. Design: Participants will be screened with: Review of medical history and medications Physical exam Blood and urine tests CT or MRI scans of parts of the body, including the brain Participants will get PT-112 in 28-day cycles, on days 1 and 15 of of the first cycle and on day 1 of each cycle after that. They will get the drug by infusion through a catheter. The catheter is a small plastic tube put into a vein. On days they receive the drug, participants will have physical exams and blood and urine tests. They will have an ECG to test heart function on day 1 of each cycle. Participants will have scans every 8 weeks. Participants may choose to have tumor biopsies on day 1 of cycles 1 and 3. Biopsies may be guided by an ultrasound or CT scan. Participants will continue treatment as long as they can handle the side effects and their disease does not get worse, for up to 8 years. Participants will have follow-up visits 2 weeks and 4 weeks after they stop therapy. Then the study team will check on participants every 3 months until 8 years after the participant joined the study.


Description:

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Study Design


Intervention

Drug:
PT-112
PT-112 will be administered intravenously in 28-day cycles, on Days 1 and 15 at a dose of 360 mg/m2 for cycle 1, and on day 1 at 250mg/m2 for each subsequent cycle,

Locations

Country Name City State
United States National Institutes of Health Clinical Center Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary overall response rate (ORR) best overall response is the best response recorded per RECIST 1.1 criteria, from the start of the treatment until disease progression/recurrence assessed every 8 weeks while on treatment and then every 3 months after that for a maximum of 8 years from the start of study
Secondary overall response rate (ORR) based on ITMIG modified RECIST (ITMIG) best overall response is the best response recorded per ITMIG modified RECIST criteria start of the treatment until disease progression/recurrence for a maximum of 8 years from the start of study
Secondary overall survival (OS) time from the date of start of treatment until death from any cause during treatment and then every 3 months for a maximum of 8 years from the start of study
Secondary progression-free survival (PFS) time from date of start of treatment until time of disease relapse, disease progression, or death assessed every 8 weeks while on treatment and then every 3 months for a maximum of 8 years from the start of study
Secondary duration of response (DOR) time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented assessed every 8 weeks while on treatment and then every 3 months for a maximum of 8 years from the start of study
Secondary safety of PT-112 type, frequency, and grade of events will be collected and reported as assessed per CTCAE criteria, version 5 safety data routinely collected from initiation of study therapy through long term follow up
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