Study on XL092 for Treating Advanced Thyroid Cancer Resistant to Radioiodine
Sponsor: Northwestern University
ClinicalTrials ID:NCT06959641
This clinical trial is testing a new drug, XL092, to see if it can help treat thyroid cancer that hasn't responded to radioiodine treatment and has spread to other parts of the body. XL092 works by blocking a protein that helps cancer cells grow.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
This Phase II study is exploring how well the drug XL092 works for patients with thyroid cancer that has not responded to radioiodine treatment and has spread either locally or to other parts of the body. XL092 is a type of medication known as a tyrosine kinase inhibitor, which helps stop cancer cells from growing by blocking certain proteins. The study aims to see if XL092 can help patients live longer without their cancer getting worse and to assess its safety and impact on quality of life.
Description
The main goal of this study is to see how effective XL092 is in helping patients with thyroid cancer that hasn't responded to radioiodine treatment. Researchers will look at how many patients are still alive and without cancer progression after 12 months of treatment. They will also evaluate the drug's effectiveness through imaging tests and measure how long patients live without their cancer getting worse. Additionally, the study will assess the overall survival time, safety, and quality of life for patients taking XL092.
Patients will take XL092 by mouth every day for 21 days in each cycle, with cycles repeating every 21 days as long as the cancer does not progress and side effects are manageable. Throughout the study, patients will undergo various tests, including CT or MRI scans, x-rays, and blood and urine tests.
After finishing the study treatment, patients will have follow-up visits 30 days later and then every three months for a year to monitor their health.
Eligibility Criteria
Inclusion Criteria
- Must have advanced thyroid cancer that has not responded to radioiodine treatment and has spread locally or to other parts of the body.
- Must be 18 years or older.
- Must have a performance status score of 2 or lower, indicating they are able to carry out daily activities with some limitations.
- Must have adequate blood cell counts and organ function as determined by specific blood tests.
- Must not have any active infections or uncontrolled medical conditions.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for a specified period after the last dose.
- Must be able to swallow pills or take medication through a feeding tube.
Exclusion Criteria
- Previous treatment with XL092.
- Active hepatitis B or C infection.
- Pregnant or breastfeeding women.
- Recent treatment with other cancer therapies or investigational drugs.
- Recent radiation therapy or surgery that has not fully healed.
- History of severe allergic reactions to similar drugs.
- Uncontrolled high blood pressure or heart conditions.
- Significant bleeding disorders or recent major bleeding events.
- Any other active cancer within the past two years, except for certain low-risk cancers.
- Recent vaccination with live vaccines.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Northwestern University | 60611 | Chicago | Illinois |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.