Phase I/IB Trial of Radiotherapy in Combination With TTI-101 in Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma
To evaluate the safety and tolerability of TTI-101 given in combination with Stereotactic Body Radiation Therapy (SBRT) in borderline resectable and locally advanced pancreatic ductal adenocarcinoma.
• Patients must have pathologically confirmed pancreatic adenocarcinoma with borderline resectable or locally advanced PDAC as defined by NCCN guidelines, with no expected arterial resection-reconstruction.
• Borderline resectable patients only: Completion of inducation chemotherpy within 1-3 weeks of study treatment start. Patients that exceed this window should complete an additional cycle of induction chemotherapy prior to initiation of study treatment, per provider discretion.
• Age ≥ 18 years at time of study entry.
• Provision to sign and date the consent form.
• Stated willingness to comply with all study procedures and be available for the duration of the study.
• Ability to swallow tablets by mouth.
• ECOG performance status ≤2 or KPS ≥60%
• Absolute neutrophil count ≥ 1,000/mcL
• Platelets ≥ 70,000/mcL
⁃ Hemoglobin ≥ 9 g/dL, patients may be transfused to meet this criterion
⁃ Serum albumin ≥ 2.8 g/dL
⁃ Total Bilirubin ≤ 2mg/dL
⁃ AST(SGOT)/ALT(SGPT)/ALP ≤ 3 x institutional upper limit of normal (IULN)
⁃ Measured creatinine clearance (CL) \>40 mL/min or Calculated creatinine CL \>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance:
⁃ Males:
⁃ Creatinine CL (mL/min) = Weight (kg) x (140 - Age) / 72 x serum creatinine (mg/dL)
⁃ Females:
⁃ Creatinine CL (mL/min) = Weight (kg) x (140 - Age) x 0.85 / 72 x serum creatinine (mg/dL)
⁃ INR ≤ 1.5 x IULN unless patient is receiving anticoagulant therapy as long as INR or PTT is within therapeutic range of intended use of anticoagulants
⁃ aPTT ≤ 1.5 x IULN unless patient is receiving anticoagulant therapy as long as INR or PTT is within therapeutic range of intended use of anticoagulants
⁃ Sexually active women of childbearing potential (defined in section 7.1) and men must agree to use at least 1 highly effective method of contraception (defined in section 7.1) from screening and for at least 30 days after administration of the last dose of the study treatment. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.