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MLN8237 for a Subject With Adenocarcinoma of the Prostate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03005262
Expanded Access Status : No longer available
First Posted : December 29, 2016
Last Update Posted : April 4, 2018
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Brief Summary:
To allow a patient continued access to MLN8237

Condition or disease Intervention/treatment
Prostate Cancer Drug: MLN8237

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

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

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: MLN8237
    Other Name: Alisertib

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male

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

No Contacts or Locations Provided

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Responsible Party: The University of Texas Health Science Center at San Antonio Identifier: NCT03005262     History of Changes
Other Study ID Numbers: CTMS 16-0122
First Posted: December 29, 2016    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
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Prostatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases