A Phase I Study of Debio1347 in Patients with Advanced Cancers Containing FGFR Alterations

Protocol
13-131
Full Title
A Phase I, Gene Alteration-Based, Open Label, Multicenter Study of Oral Debio1347 (CH5183284) in Patients with Advanced Solid Malignancies, Whose Tumors Have an Alteration of the FGFR 1, 2 or 3 Genes
Phase
I
Purpose

FGFR 1, FGFR 2, and FGFR 3 are molecules that form “receptors” on the surface of cells. These receptors are molecular switches that, when activated, can fuel cellular growth in various ways. Cancer cells can depend on FGFR 1, FGFR 2, and FGFR 3 whenever one of these receptors is in an overactive state and provides a growth advantage over healthy cells.

Such overactivation in FGFR 1, FGFR 2, and FGFR 3 is found in various types of cancer. It is brought about by changes (mutations) in the genetic blueprint of the cell that result in the receptors constantly being switched in the “on” position. Other cancer cells simply produce larger amounts of the receptor molecules through mechanisms called “amplifications” or “translocations.” One can summarize these different molecular changes as “alterations” in FGFR 1, FGFR 2, and FGFR 3.

Debio1347 is an investigational drug designed to inhibit cancer growth by potently blocking the activity of FGFR 1, FGFR 2, and FGFR 3. It should therefore slow down the growth of and kill cancer cells that depend on the activity of these molecules. Debio1347 is a pill that is taken orally (by mouth) each day.

In this study, researchers want to find the highest dose of Debio1347 that can be given safely in patients with advanced cancers that contain alterations in FGFR 1, FGFR 2, and/or FGFR 3. In doing so, they also plan to gain an early understanding of how well this drug can control cancers with overactive FGFR 1, FGFR 2, or FGFR 3.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have an advanced cancer that has returned or continued to grow despite standard therapy or for which no standard therapy exists.
  • Patients’ tumors must previously have been tested and must have been found to contain alterations in the FGFR 1, FGFR 2, or FGFR 3 genes. Examples include some bladder cancers, squamous cell and small cell lung cancers, breast cancers, stomach cancers, endometrial cancers, and head and neck cancers. However, patients with other types of cancer may also be accepted if their tumor tissue contains the appropriate molecular changes.
  • At least 2 weeks must have passed since completion of prior chemotherapy or radiation therapy and 4 weeks since major surgery.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Martin Voss at 646-422-4631.

Disease(s)
Bladder Cancer
Breast Cancer
Head & Neck Cancer
Lung Cancer, Non-Small Cell: Other
Lung Cancer, Small Cell
Solid Tumors
Upper Gastrointestinal: Gastric Cancer
Uterine (Endometrial) Cancer
Locations

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