- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03005262
MLN8237 for a Subject With Adenocarcinoma of the Prostate
April 2, 2018 updated by: The University of Texas Health Science Center at San Antonio
Expanded Access To MLN8237, For An Individual Patient With Adenocarcinoma Of The Prostate (CTMS# 16-0122)
To allow a patient continued access to MLN8237
Study Overview
Detailed Description
Expanded access to MLN8237 for an individual patient with adenocarcinoma of the prostate
Study Type
Expanded Access
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
December 22, 2016
First Submitted That Met QC Criteria
December 22, 2016
First Posted (Estimate)
December 29, 2016
Study Record Updates
Last Update Posted (Actual)
April 4, 2018
Last Update Submitted That Met QC Criteria
April 2, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CTMS 16-0122
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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