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A ComboMATCH Treatment Trial: Nilotinib and Paclitaxel in Patients with Prior Taxane Treated Solid Tumors

Protocol: ECOG – EAY191 -E4

SCHEMA EAY191-E4

Please Note: Below is a partial list of eligibility, please contact the Genesys Hurley Cancer Institute, Research Department at (810)762-8181, (810)762-8079 or (810)762-8038 to discuss the complete list of eligibility.

Eligibility:

  1. Patient must be enrolled on the ComboMATCH Registration Protocol (EAY191) at the time of registration to the EAY191-E4 study.
  2. Patient must be ≥ 18 years of age.
  3. Patient must not have any of the following mutations (as determined by the ComboMATCH Registration Protocol), which are known to confer sensitivity or resistance to nilotinib monotherapy: KIT: W557R, V559D, V559A, L576P, and K642E, PDGFR-α: D842V.
  4. Patient must have disease that can be safely biopsied and agree to a pre-treatment biopsy or have archival tissue available from within 12 months prior to the date of registration.
  5. Patient must have had at least one prior line of therapy in the metastatic setting.
  6. Patient must have previously undergone taxane therapy (in the metastatic setting).
  7. Patient must have an ECOG Performance Status of 0-2.
  8. Patient must not have had platinum-resistant epithelial serous ovarian cancer.
  9. Patient must not have peripheral neuropathy > grade 1.
  10. Patients must not have neuropathy ≥ grade 2 within 14 days of registration/randomization.
  11. Patient must have documented QT interval with Fridericia’s correction (QTcF) of ≤ 450 msec within 8 days prior to EAY191-E4 registration. Patients with a QTcF interval of ≥450 msec at registration or patients with congenital long QT syndrome are not eligible.