A Phase 1 First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Orally Administered AMG 900 in Adult Subjects with Advanced Solid Tumors.
To help us best learn how to use new drugs that may be effective treatments for cancer; Evaluate the safety and tolerability, and to evaluate the pharmacokinetics of AMG 900; Find the maximum tolerable dose and if necessary, the maximum tolerated dose with prophylactic granulocyte colony stimulating factor support; determine the dose limiting toxicity; Part 2 of the study will evaluate the clinical activity of AMG 900 in three taxane-resistant tumor types: advanced non-small cell lung cancer, breast cancer and hormone refractory prostate cancer; evaluate changes in tumor volume and tumor cell proliferation; evaluate for tumor response.
-Part 1: advanced solid tumor that is refractory to standard treatment; -Part 2 limited to advanced non-small cell lung cancer, breast cancer and hormone refractory prostate cancer -measurable or evaluable per RECIST guidelines -accessible tumor for biopsy by fine needle aspiration (only subjects in one phase of Part 1) -QTc less than 470 - good performance status -be able to give informed consent, - good organ and blood functions -no active parenchymal brain metastases -no anticoagulant within 28 days of Day 1 treatment -no treatment with known substrates or inhibitors of CYP2C family or known substrates or inhibitors of CYP3A4 for two weeks prior to D1 treatment without sponsor/investigator allowance. -No proton inhibitors or H2receptor antagonists allowed from 48 hours before first dose until one hour after the fourth dose of a treatment cycle.
Outpatient regimen of oral medication delivered the first 4 days of each 14 day cycle. Subjects self administer the AMG900 capsules on an empty stomach. Subjects fast, except for water, for two hours prior to dosing and one-hour after dosing. Subject continues until intolerable toxicity or disease progresses, Dose escalating cohorts continue until the maximally tolerated dose and dose limiting toxicities are determined. Subjects are seen weekly for the first 9 weeks and every cycle thereafter. Blood drug levels tests for organ function are checked throughout the study. EKGs are done prior to and during first cycle then once during each cycle of treatment. Scans are done at 4 weeks after start of treatment and every 8 weeks.
06/18/2013 04:02 AM