Study on SPEDOX-6 for Advanced Cancers
Sponsor: University of California, Irvine
ClinicalTrials ID:NCT07064018
This clinical trial is testing a new drug, SPEDOX-6, to find the best dose for treating advanced cancers that have not responded to other treatments. The study includes patients with specific types of cancer who have not been treated with certain chemotherapy drugs before.
Patient Parameters
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Program Overview
The purpose of this study is to determine the best dose of a new drug, SPEDOX-6, for patients with advanced cancers that have not responded to previous treatments. The trial includes patients with specific types of cancer, such as soft-tissue sarcoma, triple-negative breast cancer, non-small cell lung cancer, cervical cancer, ovarian cancer, and a type of pancreatic cancer with a specific mutation. Participants should not have been treated with anthracyclines before.
Eligibility Criteria
Inclusion Criteria
- Be 18 years or older.
- Have advanced cancer confirmed by lab tests that has not responded to at least two previous treatments.
- Have one of the following types of cancer: soft-tissue sarcoma, triple-negative breast cancer, cervical cancer, non-small cell lung cancer, ovarian cancer, or a specific type of pancreatic cancer.
- Have cancer that can be measured by standard criteria.
- Be in good overall health with a performance status score of 0 to 2.
- Have a life expectancy of at least 12 weeks.
- If HIV-positive, be on stable antiretroviral therapy with a low viral load.
- Have good heart function with a left ventricular ejection fraction over 50%.
- Have adequate organ function as shown by specific blood tests.
- Have recovered from any side effects of previous treatments.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for six months after.
- Men must agree to use effective birth control during the study and for six months after.
Exclusion Criteria
- Have a cancer with a known mutation that can be treated with a specific drug, unless you have already tried that treatment and it didn't work.
- Have had recent serious heart problems.
- Have untreated cancer that has spread to the brain.
- Have been treated with doxorubicin or similar drugs before.
- Have had radiation to the chest area.
- Have an allergy to albumin.
- Have HIV with a low CD4+ count or recent serious infections.
- Be pregnant or breastfeeding.
- Have used an investigational drug or device recently.
- Have uncontrolled diabetes.
- Need to take certain medications that affect how the body processes drugs.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Chao Family Comprehensive Cancer Center University of California, Irvine | 92868 | Orange | California |
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