Prostate CancerNCT03005262
MLN8237 for a Subject With Adenocarcinoma of the Prostate
A study testing MLN8237 in people with Prostate Cancer, run by The University of Texas Health Science Center at San Antonio.
Trial summary
To allow a patient continued access to MLN8237 Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- MLN8237
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Men only
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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
About this study
Official title: Expanded Access To MLN8237, For An Individual Patient With Adenocarcinoma Of The Prostate (CTMS# 16-0122)
To allow a patient continued access to MLN8237
Read the detailed description
Expanded access to MLN8237 for an individual patient with adenocarcinoma of the prostate
- Conditions
- Prostate Cancer
- Being tested
- MLN8237
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MLN8237Drug
Also called Alisertib
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03005262
- Sponsor's protocol ID
- CTMS 16-0122
- Status last verified
- Feb 2018
- First submitted
- 22 Dec 2016
- Last updated
- 4 Apr 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access To MLN8237, For An Individual Patient With Adenocarcinoma Of The Prostate (CTMS# 16-0122)
- ClinicalTrials.gov ID
- NCT03005262
- Acronym / sponsor ID
- CTMS 16-0122
- Conditions
- Prostate Cancer
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- First posted
- 29 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To allow a patient continued access to MLN8237
Detailed description
Expanded access to MLN8237 for an individual patient with adenocarcinoma of the prostate
Study design
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (28 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MLN8237Also: Alisertib | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing MLN8237 in people with Prostate Cancer, run by The University of Texas Health Science Center at San Antonio.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2018; AzTrials last refreshed its copy on 7 Nov 2026.