MLN8237 for a Subject With Adenocarcinoma of the Prostate

NCT03005262 | Unknown

• 1 other identifier: CTMS 16-0122
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

To allow a patient continued access to MLN8237

Conditions

Prostate Cancer

Interventions

MLN8237 DRUG

Also known as: Alisertib

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: male
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

MLN 8237

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2016
• First Posted: December 29, 2016
• Last Updated: April 4, 2018

Record last verified: 2018-02