Phase I Clinical Trial of Combined Fostamatinib and Paclitaxel in Ovarian Cancer
Johns Hopkins Kimmel Cancer Center in Baltimore
This research is being done to test the safety of the combination of the investigational drug fostamatinib and paclitaxel. This study tests different doses of the drugs to see which doses are safest in people with ovarian cancer when given together. This is the first time that the combination of fostamatinib and paclitaxel are being given together to humans. Thus, the effects of the drug, good and bad, and the correct dose of the drug to give are unknown. The word "investigational" means that fostamatinib is not approved by the U.S. Food and Drug Administration (FDA). Paclitaxel is approved by the FDA for the treatment of different early-stage and advanced cancers, including ovarian cancer, and is commonly given alone and in combination with other approved cancer treatments. Paclitaxel is not FDA approved to be given with fostamatinib and therefore this combination is investigational. The FDA is allowing the use of fostamatinib in this research study.
Patients must have:1. Confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma;2. Measurable disease on MRI or CT scan imaging;3. Recurrent, Platinum-Resistant Disease or inability to receive further platinum-based therapy;4. Ability to take oral medication; and 5. Good organ function.Patients must NOT have:1. Chemotherapy or radiotherapy within 3 months of starting the study;2. Been treated with investigational drugs within 3 weeks of starting the study;3. Known brain metastases;4. Neuropathy (Grade 2 or greater);5. History of allergic reactions to components of Paclitaxel or Fostamatinib;6. Uncontrolled concurrent illnesses;7. History of HIV, Hepatitis B or Hepatitis C; or8. Prior history of cancer (not including treated basal cell or squamous cell skin cancer, in-situ cervical cancer, or other cancers from patients who have been disease free for at least 3 years).
Eligible patients will be assigned to a specific dosage level group for combination treatment with Fostamatinib and Paclitaxel. Fostamatinib is an oral drug that is usually taken twice each day (about 12 hours apart). You will be asked to complete a diary for each dose of fostamatinib you take. Paclitaxel is given through a vein (IV) over about 60 minutes in the clinic every week for 3 weeks in a row, followed by a week off. Treatment with both drugs will continue until one of the discontinuation criteria is met.
03/05/2019 05:03 AM