mln8237 for a subject with adenocarcinoma of the prostate

Conditions: Prostate Cancer

Summary: to allow a patient continued access to mln8237

expanded access to mln8237 for an individual patient with adenocarcinoma of the prostate

Eligibility criteria:
inclusion criteria: * 18 years or older * histologically or cytologically confirmed advanced tumors and candidates for docetaxel treatment * measurable or evaluable disease is required. patients must have clinical evidence of progressive disease or persistent disease * patients with castration-resistant prostate cancer (crpc) are required to have * pathologically confirmed adenocarcinoma of the prostate * evidence of metastatic disease on bone scan or other imaging. patients with psa elevation as the only manifestation of disease are not eligible. * progressive disease after at least 1 hormonal treatment with documented testosterone levels less than 50 ng/dl * concurrent use of an agent for testosterone suppression (e.g., lhrh agonist) is required if the patient has not been surgically castrated * eastern cooperative oncology group (ecog) performance status 0-2 * recovered to less than or equal to grade 1 toxicity (ctcae), to patient's baseline status (except alopecia) or deemed irreversible from the effects of prior cancer therapy and must have evidence of progressive or persistent disease * adequate bone marrow, liver and renal function * any use of opiates must be stable for at least 2 weeks prior to study entry * male patients who agree to practice effective barrier contraception during the entire study and through 6 months after the last dose of study drug or agree to abstain from heterosexual intercourse * voluntary written consent * willing to comply with scheduled visits, treatment plan, laboratory tests and other trial procedures * suitable venous access for blood sampling exclusion criteria: * antineoplastic therapy or any experimental therapy within 21 days before the first dose of mln8237 * prior or current investigational therapies within 4 weeks before the first dose of mln8237 * radiotherapy to greater than 40% of bone marrow or any radiotherapy (except localized, small field radiation) within 4 weeks prior to enrollment, unless reviewed and approved by the medical monitor * nitrosoureas or mitomycin-c within 6 weeks before the first dose of mln8237. * autologous stem cell transplant within 3 months before the first dose of mln8237, or prior allogeneic stem cell transplant at any time. * use of enzyme-inducing antiepileptic drugs such as phenytoin, carbamazepine or phenobarbital, or rifampin, rifabutin, rifapentine or st. john's wort within 14 days prior to the first dose of mln8237 * for crpc patients: * radiotherapy or antiandrogen therapy for prostate cancer within 4 weeks prior to enrollment * prior treatment with antineoplastic chemotherapy or radioisotopes for advanced prostate cancer * use of products known to affect psa levels within 4 weeks of enrollment * major surgery within 4 weeks of study enrollment * uncontrolled high blood pressure * patients with abnormal gastric or bowel function or who require continuous treatment with antacids or proton pump inhibitors * patients receiving chronic steroid therapy other than the following: low dose steroid for the control of nausea and vomiting, topical steroid, inhaled steroid or use of dexamethasone * known severe hypersensitivity to docetaxel or other drugs formulated in polysorbate 80 * comorbid condition or unresolved toxicity that would preclude administration of docetaxel * prior history of grade 2 or greater neurotoxicity or any toxicity that has not resolved to grade 1 or below * symptomatic brain or other cns metastasis * diagnosis or treatment of another malignancy within 2 years preceding first dose of study drug except nonmelanoma skin cancer or in situ malignancy completely resected * known history of human immunodeficiency virus (hiv) infection, hepatitis b, or hepatitis c * patients requiring full systemic anticoagulation * prior allogeneic bone marrow or other organ transplant * active infection requiring systemic therapy within 14 days preceding first dose, or other serious infection * history of hemorrhagic or thrombotic cerebrovascular event in the past 12 months * serious medical or psychiatric illness that could interfere with protocol completion * inability to swallow oral medication * prior treatment with more than 3 myelosuppressive cytotoxic chemotherapy regimens * prior treatment with more than 1 prior taxane-containing regimen