Study on Nilotinib and Paclitaxel for Treating Rare Cancers

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04449549

Provider View

This clinical trial is exploring whether a combination of two drugs, nilotinib and paclitaxel, can help shrink or stop the growth of rare cancers in adults who have limited treatment options.

Patient Parameters

Program Overview

This study aims to find out if the drugs nilotinib and paclitaxel can benefit people with rare cancers that have not responded to standard treatments or for which no effective treatments exist. Participants will take nilotinib as a capsule twice daily and receive paclitaxel through an IV once a week for three weeks in a 28-day cycle. The study will monitor the effects of these drugs on the cancer and any side effects experienced by participants.

Description

This trial is designed to test a combination of two drugs, nilotinib and paclitaxel, in adults with rare cancers. Rare cancers often have limited treatment options, and researchers are looking for new ways to treat them. Nilotinib and paclitaxel have been effective in treating other types of cancer, and this study will see if they can work together to help people with rare cancers.

Participants will undergo initial screening, including medical history, physical exams, blood and urine tests, and imaging scans to measure their tumors. They will then receive nilotinib and paclitaxel in 28-day cycles. Nilotinib is taken as a capsule twice a day, while paclitaxel is given through an IV once a week for the first three weeks of each cycle.

Participants will keep a diary to track when they take the drugs and any side effects they experience. Optional tumor biopsies may be conducted to gather more information about the cancer's response to treatment. Participants can continue in the study until their cancer worsens or they experience intolerable side effects. A follow-up phone call will be conducted about 30 days after the last dose of the study drugs.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 and older with rare solid tumors that have progressed after standard treatment or for which no standard treatment exists.
  • Must have measurable disease.
  • Good overall health with an ECOG performance status of 0 to 2.
  • Normal organ and marrow function, including:
    • Neutrophil count of at least 1,500/mcL
    • Platelet count of at least 100,000/mcL
    • Total bilirubin within 1.5 times the normal limit
    • AST/ALT within 3 times the normal limit, or 5 times if liver metastases are present
    • Creatinine within 1.5 times the normal limit or creatinine clearance of at least 60 mL/min/1.73 m²
  • Agree to use effective contraception during the study and for 3 months after.
  • Completed any prior major treatments at least 3 weeks before starting the study.
  • Optional submission of a tumor biopsy sample from a previous study or medical care.
  • HIV-positive patients on effective therapy with undetectable viral load are eligible.

Exclusion Criteria

  • QTcF interval of 450 msec or more at study entry.
  • Significant sensory or motor neuropathy.
  • Currently receiving other investigational treatments.
  • Known primary CNS cancer or symptomatic CNS metastases, unless specific criteria are met.
  • History of severe allergic reactions to similar drugs.
  • Uncontrolled illnesses, such as serious infections or heart conditions.
  • Pregnant or breastfeeding women, due to potential risks to the baby.

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