PT-112 in Subjects With Thymoma and Thymic Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-120
SponsorNational Cancer Institute (NCI)
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants must have histologically confirmed thymoma or thymic carcinoma.
Participants should have received at least one prior line of platinum-based chemotherapy. For participants who have refused cytotoxic chemotherapy, a rationale for refusal to receive standard first-line therapy will be captured in the case report form and the medical record. Progressive disease must be documented prior to study entry and participants must have advanced, unresectable disease that is not amenable to surgical resection.
Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1.
Participants must be aged >=18 years.
Disqualifiers
History of allergic reactions attributed to compounds of similar chemical or biologic composition to PT-112. Since there is no definitive list of compounds of similar chemical or biologic composition to PT-112, the principal investigator if in doubt, will report known allergies to the pharmacist to make a determination as to whether it is safe to enroll a participant.
Concurrent treatment with a non-permitted drug.
Concurrent anticancer treatment within 14 days before initiation of study therapy (includes radiotherapy; however, palliative bone-directed radiotherapy is permitted).
Major surgery within 14 days before enrollment (excluding prior diagnostic biopsy).
Trial design
Design model
Single group
Treatments tested in this trial
PT-112
DrugPT-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,
Treatment groups
53 Participants
are divided into 1 treatment groupGroup A: PT-112Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
assessed every 8 weeks while on treatment and then every 3 months after that for a maximum of 8 years from the start of studySecondary outcomes
1
overall response rate (ORR) based on ITMIG modified RECIST (ITMIG)
best overall response is the best response recorded per ITMIG modified RECIST criteria
Time frame
start of the treatment until disease progression/recurrence for a maximum of 8 years from the start of study2
overall survival (OS)
time from the date of start of treatment until death from any cause
Time frame
during treatment and then every 3 months for a maximum of 8 years from the start of study3
progression-free survival (PFS)
time from date of start of treatment until time of disease relapse, disease progression, or death
Time frame
assessed every 8 weeks while on treatment and then every 3 months for a maximum of 8 years from the start of study4
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
Time frame
assessed every 8 weeks while on treatment and then every 3 months for a maximum of 8 years from the start of studySponsors and contacts
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Source ClinicalTrials.gov