Phase 2 Peripheral Neuropathy Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with thymoma or thymic carcinoma, confirmed by laboratory testing of tissue samples.
• People who have already received at least one round of platinum-based chemotherapy, or who have declined standard chemotherapy (with the reason recorded in their medical file).
• People whose cancer has been confirmed as getting worse before joining the study, and whose disease cannot be removed by surgery.
• People who have at least one area of cancer that can be measured on a scan using a standard method called RECIST 1.1.
• People aged 18 years or older.
• People who are generally well enough to carry out light activity and care for themselves (rated 0 or 1 on a standard health scale called ECOG).
• People whose blood counts, liver function, and kidney function meet the minimum levels required by the trial (confirm specific values with the trial site).
• People who are not pregnant at the start of the study — a pregnancy test will be required for anyone who could potentially become pregnant, unless proven menopause or surgical sterilisation is confirmed.
• People who agree to use effective contraception during the study and for 6 months after the last dose of the study drug — this applies to anyone who could become pregnant or father a child.
• People who have previously treated brain or nervous system cancer spread (metastases), provided they have recovered from any side effects of radiation treatment, are not currently taking steroids for this, and any whole-brain radiation was completed at least 2 weeks before starting the study.
• People who are willing and able to understand and sign a written consent form.

Who may not be able to join:

• People who have had a serious allergic reaction to drugs that are chemically similar to the study drug PT-112 (the trial site pharmacist will assess this if there is any uncertainty).
• People who are currently taking a drug that is not permitted alongside the study treatment.
• People who have had any other cancer treatment — including radiation therapy — within 14 days before starting the study (note: radiation therapy aimed at relieving bone pain is allowed).
• People who have had major surgery within 14 days before joining (routine diagnostic biopsies are not included in this).
• People who have taken immune-suppressing medications within 14 days (or within 5 half-lives of the drug, whichever is shorter) before starting the study.
• People who have used hormonal treatments for cancer, or any other experimental drug, within 14 days before starting the study.
• People who have had another cancer diagnosis within the past 2 years — exceptions include certain skin cancers, early-stage cervical cancer, early-stage breast cancer, certain thyroid cancers, and early-stage bladder cancer.
• People who have an active infection requiring treatment, or who test positive for active Hepatitis B or Hepatitis C at screening.
• People who are known to be HIV-positive with a detectable viral load — however, people with HIV who have an undetectable viral load and are on a stable HIV treatment regimen may be considered (confirm with trial site).
• People who still have significant side effects (rated above Grade 1) from previous cancer treatments, with the exception of hair loss, mild-to-moderate nerve-related symptoms (Grade 2 or below), and mild-to-moderate hearing loss (Grade 2 or below).
• People with a known problem with alcohol or drug misuse.
• People with certain serious uncontrolled health conditions, including: symptomatic heart failure, unstable chest pain, or serious heart rhythm problems (active or within the past 6 months); certain serious lung conditions not caused by radiation (active or within the past 6 months); immune-related bowel conditions (active or within the past 6 months); serious bleeding disorders or major bleeding events (active or within the past 6 months); or serious mental health conditions, including active thoughts of self-harm (active or within the past 12 months).
• People who have received a live vaccine within 4 weeks before starting treatment (COVID-19 vaccines are allowed at the screening stage).

Important: Always verify eligibility with the trial site directly before applying.