Clinical Corner
Study of innovative cancer radiation response blood test opens at UF
Study of Innovative Cancer Radiation Response Blood Test Opens at UF
While radiation is required by 70% of cancer patients, there is currently no reliable methodology for determining its adverse effects during treatment. A clinical study at UF is aiming to change this.
Blood specimens are being collected and analyzed from up to 500 patients undergoing radiotherapy for prostate cancer at multiple U.S. clinical sites. The study aims to create personalized toxicity endpoints so that patients can be subcategorized into risk groups.
“We are fulfilling an unmet medical need in cancer radiation therapy by enabling the direct monitoring of side effect severity and tumor response within days of treatment initiation,” said Paul Okunieff, M.D., co-principal investigator and chair of the department of radiation oncology at the UF College of Medicine. “ It is a very exciting opportunity for the UF department of radiation oncology and the Okunieff Lab to make a real difference in the quality and safety of care for individual cancer patients.”
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Clinical Trial Highlight
University of Florida Health is proud to offer options for our patients.
Questions about how to send a patient? Please contact the Clinical Trials Office at cancer-center@ufl.edu or 352.273.8675.
Oral TP-3654 in Patients With Intermediate-2 and High-Risk Primary or Secondary Myelofibrosis
This study is an open-label trial to assess safety, tolerability, pharmacokinetics and pharmacodynamics of TP-3654 in patients with intermediate-2 and high-risk primary or secondary Myelofibrosis. This study will enroll patients who have been previously treated and failed on a JAK inhibitor or ineligible to receive ruxolitinib or fedratinib.
Principal Investigator: Randy Brown, M.D., 859-221-6828
A Phase 2 Study of Savolitinib in Subjects with MET Amplified Colorectal Cancer
This Phase 2, open-label study is testing the orally administered cMet kinase inhibitor, Savolitinib in subjects with MET amplified adenocarcinoma of the colon and rectum. Patients with metastatic colorectal cancer who have received prior anti-EGFR monoclonal antibody therapy (cetuximab or panitumumab) will be prospectively screened for MET amplification using the Guardant 360 cell free DNA assay. Patients MUST sign the screening informed consent form prior to performance of the Guardant 360, if MET amplification is detected, the patient may proceed to receive study treatment with Savolitinib.
Principal Investigator: Thomas George, M.D., 352-339-6672
A Phase 2 Study of Olaparib and AZD6738 in Isocitrate Dehydrogenase (IDH) Mutant Solid Tumors
This Phase 2, open-label study of oral PARP inhibition (olaparib) and oral ATR inhibition (AZD6738) in subjects with recurrent/progressive, IDH1/2-mutant solid tumors. Available cohorts include cholangiocarcinoma, and other solid malignant tumors. IDH1/2 mutations must be established through CLIA-approved molecular testing of the tumor, but additional biopsies for confirmatory testing may be required.
Principal Investigator: Thomas George, M.D., 352-339-6672
Durvalumab With or Without Olaparib as Maintenance Therapy After First-Line Treatment of Advanced and Recurrent Endometrial Cancer (DUO-E)
This Phase 3 study will assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.
Principal Investigator: Merry Jennifer Markham, M.D., FACP, FASCO, 352-262-1072
A Phase 1b/2 Study of XMT-1536 In Cancers Likely to Express NaPi2b
First-in-human, Phase 1b/2 safety study of the antibody-drug conjugate (ADC) XMT-1536 (upifitamab rilsodotin) administered as an IV infusion once every four weeks. Patients with tumor types likely to express NaPi2b are being enrolled in dose escalation. Patients with platinum-resistant ovarian cancer and non-small cell lung cancer (adenocarcinoma subtype) are being enrolled in the expansion segment of the this study. Patients with platinum-resistant, high-grade serous ovarian cancer are being enrolled in the UPLIFT segment of this study. In addition to safety assessments, the pharmacokinetics of the drug will be assessed along with ADC activity.
Principal Investigator: Frederic Kaye, M.D., 352-672-8860
FRACTION-GC: A Study to Test Combination Treatments in Patients With Advanced Esophagogastric Cancer
A Phase 2 study to determine whether Nivolumab in combination with other novel therapies is effective in treating patients/subjects with advanced esophagogastric cancer. Eligible patients must be at least 18 years or older, with inoperable, advanced, or metastatic esophageal cancer, gastric cancer, or gastroesophageal junction carcinoma, and have histologically confirmed predominant adenocarcinoma or squamous cell carcinoma. Patients may not have received prior treatment with a PARP inhibitor, or targeted DNA damage response inhibitor, but prior checkpoint inhibitor therapy is allowed.
Principal Investigator: Thomas George, M.D., 352-339-6672
A Study of VB-111 with Paclitaxel vs Paclitaxel for Treatment of Recurrent Platinum-Resistant Ovarian Cancer (OVAL)
A Phase 3, randomized, multicenter study to compare VB-111 and paclitaxel to placebo and paclitaxel in adult patients with recurrent platinum-resistant ovarian cancer. VB-111/Placebo will be administered as an IV infusion every two months, with paclitaxel administered as an IV infusion once a week. Patients who are known to carry a BRCA mutation may be enrolled only following PARP inhibitor treatment failure, or being intolerant of PARP inhibitor treatment.
Principal Investigator: Merry Jennifer Markham, M.D., FACP, FASCO, 352-262-1072
