Pidnarulex for Cancer
Trial Summary
What is the purpose of this trial?
This phase I trial tests the safety, side effects, and best dose of pidnarulex (CX-5461) in treating patients with solid tumors that have spread from where it first started (primary site) to other places in the body (metastatic). Pidnarulex is an oral inhibitor of ribonucleic acid polymerase I, with potential antineoplastic activity. It blocks a certain enzyme needed for cell division and deoxyribonucleic acid (DNA) repair and may kill cancer cells.
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications, but you cannot participate if you are taking strong CYP3A4 inhibitors or inducers, as they may interact with the study drug. It's best to discuss your current medications with the trial team to determine eligibility.
What data supports the effectiveness of the drug Pidnarulex for cancer?
The research does not provide direct evidence about Pidnarulex, but it highlights the effectiveness of paclitaxel, a similar cancer drug, which has shown significant activity in various cancers, including ovarian and breast cancer. Paclitaxel's success in combination therapies suggests that Pidnarulex might also be effective when used with other agents.12345
Is Pidnarulex safe for humans?
Research Team
A P Chen
Principal Investigator
National Cancer Institute LAO
Eligibility Criteria
This trial is for adults with solid tumors that have spread and worsened after at least one prior treatment. They must have a tumor measurable by medical imaging, be able to undergo a biopsy, and be in decent physical shape (able to perform light activities). Blood counts and liver function need to meet specific levels.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive pidnarulex IV over 60 minutes on days 1 and 8 of each 28-day cycle. Patients also undergo CT or MRI, biopsy, and collection of blood samples throughout the trial.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
Treatment Details
Interventions
- Pidnarulex
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor