Study on Docetaxel and SX-682 for Recurrent/Metastatic Head and Neck, Salivary Gland, and Advanced Prostate Cancer
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT07667400
This clinical trial is testing a new combination of drugs, SX-682 and docetaxel, to see if they can help treat head and neck cancers, salivary gland cancers, and advanced prostate cancer that have returned or spread after treatment.
Patient Parameters
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Program Overview
The study aims to evaluate a new drug, SX-682, combined with an existing drug, docetaxel (DTX), for treating head and neck cancers, salivary gland cancers, and advanced prostate cancer. These cancers often have poor survival rates when they spread or return after treatment, so better treatments are needed. Participants will take SX-682 as a tablet and receive DTX through an IV. The study will monitor the safety and effectiveness of this combination over several cycles of treatment.
Description
This study focuses on improving treatment for certain cancers that have returned or spread after initial treatment. It involves two drugs: SX-682, a new drug that may help the immune system fight cancer, and docetaxel (DTX), a drug already used to treat these cancers. The study will test if combining these drugs can improve outcomes for patients with head and neck cancers, salivary gland cancers, and advanced prostate cancer.
Participants will take SX-682 as a tablet twice daily for 11 days in each 3-week cycle. They will also receive DTX through an IV on the 8th day of each cycle. This treatment will continue for up to 6 cycles, depending on how well the cancer responds and if there are any side effects.
The study will have two phases. Phase I will determine the safest dose of SX-682 to use with DTX. Phase II will evaluate how effective the combination is at shrinking tumors. Participants will have regular check-ups, including blood tests and scans, to monitor their health and the treatment's effects.
After completing the treatment cycles, participants will have follow-up visits to check their progress and any long-term effects of the treatment. These visits will continue for up to 5 years.
Eligibility Criteria
Inclusion Criteria
- Be 18 years or older.
- Have a confirmed diagnosis of head and neck cancer, salivary gland cancer, or advanced prostate cancer that has returned or spread.
- Have previously received standard treatment for their cancer or cannot tolerate standard treatment.
- Be in good overall health with a performance status score of 0 to 2, meaning fully active or able to carry out light work.
- Have adequate organ and blood function as determined by specific tests.
- Agree to use effective contraception during the study and for a period after treatment.
- Be able to swallow oral medications.
- Have controlled HIV, hepatitis B, or hepatitis C infections if applicable.
- Understand the study and agree to sign informed consent.
Exclusion Criteria
- Have a history of severe allergic reactions to similar drugs.
- Have active brain metastases unless previously treated and stable.
- Have received other investigational drugs or major surgery recently.
- Be taking medications that strongly affect liver enzymes.
- Have another cancer that could interfere with the study.
- Have serious uncontrolled illnesses that could increase risk or affect study results.
- For head and neck cancer patients, have received large-field radiotherapy recently.
- For prostate cancer patients, be using certain medications for urinary symptoms or have cancer-related neuropathy.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| National Institutes of Health Clinical Center | 20892 | Bethesda | Maryland |
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