Study on Using Nilotinib and Paclitaxel for Patients with Progressive Solid Cancers Previously Treated with Taxane Therapies
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT05554341
This clinical trial is testing a combination of two drugs, nilotinib and paclitaxel, to see if they can help treat solid cancers that have continued to grow or spread after previous treatment with taxane therapies.
Patient Parameters
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Program Overview
This study is exploring whether a combination of two drugs, nilotinib and paclitaxel, can effectively treat solid cancers that have not responded to previous taxane treatments. Nilotinib works by blocking a protein that helps cancer cells grow, while paclitaxel stops cancer cells from dividing. Together, these drugs may help slow down or stop the growth of cancer cells in patients whose cancer has progressed despite earlier treatments.
Description
The main goal of this study is to see how many patients with advanced cancers that did not respond to taxane treatments show improvement when treated with nilotinib and paclitaxel. Researchers will also collect tissue samples to study the genetic makeup of the tumors and see how they respond to the treatment.
Patients in the study will take nilotinib by mouth twice a day and receive paclitaxel through an IV on specific days of each 28-day cycle. The treatment cycles will continue as long as the cancer does not progress and the side effects are manageable. Throughout the study, patients will have regular scans and provide blood and tissue samples to monitor their response to the treatment. After finishing the treatment, patients will be followed for up to three years to track their health and any changes in their cancer.
Eligibility Criteria
Inclusion Criteria
- Must be enrolled in the ComboMATCH registration study.
- Must be 18 years or older.
- Must not have specific genetic mutations that affect response to nilotinib.
- Must have cancer that can be safely biopsied or have recent tissue samples available.
- Must be willing to provide blood samples for research.
- Must have had at least one previous treatment for metastatic cancer.
- Must have received taxane therapy before, with specific conditions based on response.
- Must have a performance status score of 0-2, indicating good overall health.
- Must not have platinum-resistant ovarian cancer.
- Must not have severe nerve damage.
- Must have a normal heart rhythm as measured by a specific test.
- Must not be pregnant or breastfeeding and agree to use contraception during the study.
- Must have progressive disease.
- Must meet specific blood count and organ function requirements.
- Must be able to swallow medications.
- Must have completed any previous treatments within a specified time before joining the study.
- Patients with treated brain metastases are eligible if stable for at least one month after treatment.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | 35233 | Birmingham | Alabama |
| Kingman Regional Medical Center | 86401 | Kingman | Arizona |
| Stanford Cancer Institute Palo Alto | 94304 | Palo Alto | California |
| Presbyterian Intercommunity Hospital | 90602 | Whittier | California |
| UCHealth University of Colorado Hospital | 80045 | Aurora | Colorado |
| UM Sylvester Comprehensive Cancer Center at Aventura | 33180 | Aventura | Florida |
| UM Sylvester Comprehensive Cancer Center at Coral Gables | 33146 | Coral Gables | Florida |
| UM Sylvester Comprehensive Cancer Center at Deerfield Beach | 33442 | Deerfield Beach | Florida |
| University of Miami Miller School of Medicine-Sylvester Cancer Center | 33136 | Miami | Florida |
| UM Sylvester Comprehensive Cancer Center at Kendall | 33176 | Miami | Florida |
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