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Anti-tumor antibiotic
PT-112 for Thymic Cancer
Phase 2
Recruiting
Led By Arun Rajan, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
- creatinine <= 1.5x ULN OR: creatinine clearance >= 60 mL/min/1.73 m2 calculated by calculated using eGRF in the clinical lab
- Female participants must not become pregnant or start breast feeding during the study. Breastfeeding should be discontinued if the mother is treated with PT-112.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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
Awards & highlights
Study Summary
This trial is testing the drug PT-112 to see if it can help people with thymoma or thymic cancer whose disease returned or progressed after treatment with at least one platinum-containing chemotherapy.
Who is the study for?
Adults aged 18+ with thymoma or thymic carcinoma that has returned or worsened after platinum-based chemotherapy, or those who refused standard treatment. They must have measurable disease, adequate organ and marrow function, and not be pregnant or breastfeeding. Contraception is required for participants of childbearing potential.Check my eligibility
What is being tested?
The trial tests PT-112, a drug designed to kill cancer cells and boost the immune system's ability to fight cancer. Participants will receive PT-112 through an infusion on specific days in a 28-day cycle and will continue as long as they tolerate side effects without worsening of their disease.See study design
What are the potential side effects?
While the exact side effects are not listed here, common ones may include reactions at the infusion site, fatigue, changes in blood counts affecting immunity and clotting, heart issues detectable by ECG (as monitored), plus any general risks associated with biopsies.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function, measured by creatinine levels or clearance, is within the required range.
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I am not pregnant or breastfeeding, and will not become pregnant during the study.
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My cancer is confirmed to be thymoma or thymic carcinoma.
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I am not pregnant and either cannot have children or am not currently able to.
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My cancer has worsened and cannot be removed with surgery.
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My liver enzymes are within the required range.
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I am fully active and can carry on all my pre-disease activities without restriction.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
overall response rate (ORR)
Secondary outcome measures
duration of response (DOR)
overall response rate (ORR) based on ITMIG modified RECIST (ITMIG)
overall survival (OS)
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: PT-112Experimental Treatment1 Intervention
PT-112 will be administered intravenously on Days 1, 8 and 15 of a 28-day cycle at a dose of 360 mg/m2 until disease progression, development of intolerable adverse events, or until 8 years after an individual participant has been on study
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PT-112
2017
Completed Phase 2
~100
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,665 Previous Clinical Trials
40,925,801 Total Patients Enrolled
2 Trials studying Thymic Epithelial Tumors
2,038 Patients Enrolled for Thymic Epithelial Tumors
Arun Rajan, M.D.Principal InvestigatorNational Cancer Institute (NCI)
15 Previous Clinical Trials
3,683 Total Patients Enrolled
2 Trials studying Thymic Epithelial Tumors
2,038 Patients Enrolled for Thymic Epithelial Tumors
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function, measured by creatinine levels or clearance, is within the required range.I do not have any active infections needing systemic treatment.I am not pregnant or breastfeeding, and will not become pregnant during the study.I had brain or CNS cancer treatment, am off steroids, and finished radiation 2 weeks ago.I have not had major surgery in the last 2 weeks.I have not received any live vaccines in the last 4 weeks, except for the COVID-19 vaccine.You have a history of alcohol or drug abuse.My cancer is confirmed to be thymoma or thymic carcinoma.I haven't had cancer in the last 2 years, except for certain skin, cervical, breast, thyroid, or bladder cancers.I am not pregnant and either cannot have children or am not currently able to.I have HIV but my viral load is undetectable and I am on stable HAART.I haven't used hormonal cancer therapy or investigational drugs in the last 14 days.I haven't had cancer treatment in the last 14 days, except for palliative care for bones.You have a mental health condition or difficult life circumstances that may make it hard for you to follow the study rules, including having thoughts of hurting yourself or others in the past year.I haven't taken immunosuppressive drugs in the last 14 days or 5 half-lives of the drug.I have not had serious heart problems like heart failure, chest pain, or irregular heartbeat in the last 6 months.My cancer has worsened and cannot be removed with surgery.My organs and bone marrow are functioning well.I have had platinum-based chemotherapy before.I am using effective birth control and will continue for 6 months after the last dose.I have lasting side effects from past treatments, but not including hair loss, mild nerve pain, or mild hearing loss.My liver enzymes are within the required range.I haven't had immune colitis or inflammatory bowel disease in the last 6 months.I do not have any uncontrolled illnesses.I haven't had major bleeding or bleeding disorders in the last 6 months.I am fully active and can carry on all my pre-disease activities without restriction.I am 18 years old or older.I have had pneumonitis or idiopathic pulmonary fibrosis in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: PT-112
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
When might we see PT-112 on the market?
"PT-112 falls into Phase 2 of clinical trials, meaning that while there is safety data, there is none yet supporting efficacy."
Answered by AI
Can people with the required qualifications sign up for this clinical trial right now?
"This study, which is currently looking for participants, was first posted on April 6th, 2022. The most recent update to the trial was on October 13th, 2022."
Answered by AI
How many people can sign up for this research project?
"That is correct. The clinicaltrials.gov website currently has information indicating that this trial is seeking participants. This study was originally posted on April 6th, 2022 and updated on October 13th, 2022. They are looking for 53 people to participate at 1 location."
Answered by AI
Who else is applying?
What site did they apply to?
National Institutes of Health Clinical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I have tried all other treatments including Surgery , Radiotherapy and Chemotherapy, but i always have disease progression. I am in a very good general health condition and i believe your Trial sounds very promising.
PatientReceived 1 prior treatment
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- National Institutes of Health Clinical Center: < 48 hours
Average response time
- < 2 Days
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