MLN8237 for a Subject With Adenocarcinoma of the Prostate

Study Overview
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Brief Summary
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To allow a patient continued access to MLN8237

Detailed Description
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Expanded access to MLN8237 for an individual patient with adenocarcinoma of the prostate

Official Title
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Expanded Access To MLN8237, For An Individual Patient With Adenocarcinoma Of The Prostate (CTMS# 16-0122)

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: MLN8237


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Male

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MLN8237|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |