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NCT05104736 · ClinicalTrials.gov registry record · Phase 2
PT-112 in Subjects With Thymoma and Thymic Carcinoma
A Phase 2 study of Thymic Cancer and Thymic Epithelial Tumor, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 53
- Enrollment target
- 1
- Study location
NCT05104736: Recruiting Phase 2 study of Thymic Cancer and Thymic Epithelial Tumor, sponsored by National Cancer Institute (NCI).
NCT05104736 is a Phase 2 study of Thymic Cancer and Thymic Epithelial Tumor that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 53 participants, above the 10-participant average among 4 other Thymic Cancer trials with a reported enrollment target (430% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05104736, a Phase 2 study of Thymic Cancer and Thymic Epithelial Tumor, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 53 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
best overall response is the best response recorded per RECIST 1.1 criteria, from the start of the treatment until disease progression/recurrence
Conditions Studied
Interventions
- DRUG PT-112
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2022-04-06 |
| Est. Completion | 2027-06-30 |
| Phase | Phase 2 |
What NCT05104736 shows while recruiting
NCT05104736 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, above the 10-participant average among 4 other Thymic Cancer trials with a reported enrollment target (430% higher).
The record links to 3 conditions, with Thymic Cancer appearing as the primary indexed condition, and to 1 intervention - of which PT-112 is the first listed.
NCT05104736 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT05104736 about?
NCT05104736 is a clinical study titled "PT-112 in Subjects With Thymoma and Thymic Carcinoma". 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 i...
What is the current status of trial NCT05104736?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 53 participants. The study started on 2022-04-06. Estimated completion is 2027-06-30.
What conditions does trial NCT05104736 study?
This clinical trial studies the following conditions: Thymic Cancer, Thymic Epithelial Tumor, Recurrent Thymoma.
What interventions are being tested in trial NCT05104736?
The interventions under investigation include: PT-112 (DRUG).
Who is sponsoring clinical trial NCT05104736?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05104736 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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