Clinical Trials

Text Size A A

E-Mail to a Friend






secret  Click to Play Audio


Prostate Cancer Clinical Trials

MLN8237 for Patients With CRPC Receiving a Standard Docetaxel/Prednisone Regimen (20100481)
A Randomized Phase 2 Study of MLN8237, an Aurora A Kinase Inhibitor, or No MLN8237 in Patients with Castration-Resistant Prostate Cancer Receiving a Standard Docetaxel/Prednisone Regimen, Preceded by a Phase I Dose-Escalation Study - Part 1 and 2
Status Conditions Phase Study ID
Closed Genitourinary Cancer; Prostate Cancer; Solid Tumors Phase I/II 20100481
NCT01094288
Summary

Purpose This is a randomized, open-label, multicenter, Phase 2, two-arm study that will evaluate the efficacy and safety of MLN8237 given orally in combination with docetaxel and prednisone as a treatment for castration-resistant prostate cancer (CRPC). It will be preceded by a Phase 1 portion to determine tolerable doses and schedules of MLN8237 and docetaxel to be evaluated in the Phase 2 portion.


Investigator
Tia Higano, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
Criteria

Inclusion Criteria:

Each patient must meet all of the following inclusion criteria to be enrolled in the study:

  • Males 18 years or older
  • Pathologically confirmed adenocarcinoma of the prostate
  • PSA > 5 ng/mL or radiographically measurable disease
  • Evidence of metastatic disease on bone scan or other imaging
  • Progressive disease after at least 1 hormonal treatment
  • Concurrent use of an agent for testosterone suppression 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
  • Patients who agree to practice effective barrier contraception 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:

Patients meeting any of the following exclusion criteria are not to be enrolled in the study:

  • Prior treatment with antineoplastic chemotherapy or radioisotopes for metastatic prostate cancer
  • Prior or current investigational therapies within 4 weeks before the first dose of MLN8237
  • Radiotherapy or antiandrogen therapy for prostate cancer within 4 weeks prior to enrollment
  • Use of products known to affect PSA levels within 4 weeks of enrollment
  • Radiotherapy to greater than 25% of bone marrow
  • Localized radiation within 4 weeks of enrollment
  • Compromised bone marrow including patients with a superscan result on a bone scan
  • Major surgery within 4 weeks of study enrollment
  • Uncontrolled high blood pressure
  • 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 and prednisone
  • Medical contraindication to any of the docetaxel pre-medications
  • 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
  • Uncontrolled pain at baseline, impending complication from bone metastasis and/or presence of urinary obstruction

 

Exclusions (conditions that would prevent participation in this study)

Patients meeting any of the following exclusion criteria are not to be enrolled in the study: - Prior treatment with antineoplastic chemotherapy or radioisotopes for metastatic prostate cancer - Prior or current investigational therapies within 4 weeks before the first dose of MLN8237 - Radiotherapy or antiandrogen therapy for prostate cancer within 4 weeks prior to enrollment - Use of products known to affect PSA levels within 4 weeks of enrollment - Radiotherapy to greater than 25% of bone marrow - Localized radiation within 4 weeks of enrollment - Compromised bone marrow including patients with a superscan result on a bone scan - Major surgery within 4 weeks of study enrollment - Uncontrolled high blood pressure - 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 and prednisone - Medical contraindication to any of the docetaxel pre-medications - 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 - Uncontrolled pain at baseline, impending complication from bone metastasis and/or presence of urinary obstruction Other exclusion criteria may apply.

Last Updated
September 16, 2013
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.