Study on Combining Anti-Cancer Drugs Selumetinib and DS-8201a for Advanced Pancreatic Cancer
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT07619521
This clinical trial is testing a new combination of drugs, selumetinib and DS-8201a, to see if they are safe and effective in treating advanced pancreatic cancer that cannot be removed by surgery or has spread to other parts of the body.
Patient Parameters
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Program Overview
The purpose of this study is to evaluate the safety, side effects, and best dose of selumetinib combined with DS-8201a for treating advanced pancreatic cancer. Selumetinib may help stop cancer cell growth by blocking certain enzymes, while DS-8201a targets and kills HER2 positive cancer cells. This study aims to determine if this combination is safe and effective for patients with advanced pancreatic cancer that cannot be surgically removed or has spread.
Description
This study is divided into two phases: Phase I focuses on finding the safest dose of the drug combination, while Phase II evaluates how well the treatment works in shrinking tumors. Participants will take selumetinib orally twice a day and receive DS-8201a through an IV every 21 days. The study will monitor the safety and effectiveness of the treatment, including any side effects and how well it controls the cancer. Patients will undergo regular health checks, including heart scans and blood tests, throughout the study. After completing the treatment, participants will have follow-up visits every three months for a year to monitor their health.
Eligibility Criteria
Inclusion Criteria
- Must have confirmed pancreatic cancer that cannot be removed by surgery or has spread.
- Cancer must have a specific KRAS mutation and be HER2 positive.
- Must have measurable cancer that can be tracked using standard criteria.
- Must have tried at least one chemotherapy treatment for advanced pancreatic cancer.
- Must be 18 years or older.
- Must be in relatively good health with a performance status score of 2 or lower.
- Must have adequate blood counts and organ function as determined by specific tests.
- Must not be pregnant and agree to use effective contraception during and after the study.
- Must be willing to sign an informed consent document.
Exclusion Criteria
- Have received prior treatment with MEK inhibitors or HER2-directed therapies.
- Have had recent chemotherapy, immunotherapy, or major surgery.
- Have a history of severe allergic reactions to similar drugs.
- Have uncontrolled illnesses or infections.
- Have significant heart or lung conditions.
- Are pregnant or breastfeeding.
- Have received a live vaccine recently.
- Have unresolved side effects from previous cancer treatments.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Yale University Cancer Center LAO | 06520 | New Haven | Connecticut |
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