Any patient with a potentially curable malignancy who has not yet received appropriate standard therapies
Anti seizure drugs known inducers of cytochrome P450
Documented HIV, active hepatitis B or C infections
Patients with active or uncontrolled infections or with serious illnesses or medical conditions, which would not permit the patient to be managed according to protocol
Pregnant or lactating women; both men and women enrolled on study should be using adequate birth control measures throughout the course of the study. Women of childbearing potential must have a negative serum or urine pregnancy test documented within 14 days prior to registration and at study start
Inability or refusal to practice contraception during therapy of ECO-4601, unless patient is surgically sterile or woman is postmenopausal for at least 2 years
Patients who have been treated with any investigational drug within 4 weeks of patient's signature of informed consent form, or who are receiving concurrent treatment with other experimental drugs or anti cancer therapy
Patients in whom a proper central line cannot be established
Concomitant therapy with therapeutic coumadin; patients can be transferred to low molecular weight heparin
Patients on low molecular weight heparin for \< 2 weeks prior to ICF signature
Polysorbate 80 being a major constituent of ECO-4601 and known to cause hypotension, patients with uncontrolled hypotension will be excluded
Known hypersensitivity to farnesylated dibenzodiazepinone or any of the formulation components
Concomitant Therapy Permitted:
Patients may receive ongoing supportive and palliative care (eg: pain control) as clinically indicated throughout the study.
Patients can be treated with corticosteroids if medically needed
Usage of low molecular weight heparin is allowed
Anti seizure products are permitted provided they are not inducers of cytochrome P450.
Concomitant Therapy Not Permitted:
Other anticancer treatment
Other investigational therapy
Concomitant therapy with coumadin
Cytochrome enzyme inducing anti epileptics
G-CSF, GM-CSF and other growth factors may not be used as a substitute for a scheduled dose reduction; however they may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated at the discretion of the investigator. Use of erythropoietin is allowed if treatment has been initiated for ≥ 2 months. Use of growth factors must be documented on case report forms.
Hormonal therapy
Clareo Health | A Phase I Study of ECO-4601 in Patients With Advanced Cancer
