Chemo-naïve metastatic prostate cancer subjects with documented rising Prostate Specific Antigen (PSA) or documented Progressive Disease (PD) following hormonal therapy MedDRA version: 16.1 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Revlimid 10 mg, hard capsules
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: LENALIDOMIDE
CAS Number: 191732-72-6
Current Sponsor code: CC-5013
Concentration unit: mg milligram(s
Sponsors
Celgene Corporation
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Understand and voluntarily sign an Informed Consent Form (ICF) 2. Males = 18 years of age at the time of consent 3. Able to adhere to the study visit schedule and requirements of the protocol 4. ECOG performance status of = 2 5. Life expectancy of = 12 weeks 6. Willingness to participate in HRQoL and pain assessments and have ability to complete PRO and pain assessments without assistance or with minimal assistance from trained site personnel and/or caregiver 7. Effective castration (defined as serum testosterone levels < 50 ng/dL): - Primary testicular androgen suppression (e.g., LHRH agonists or antagonists) should be continued during study treatment for subjects who have not had a bilateral orchiectomy. 8. Histologically confirmed adenocarcinoma of the prostate and: - Prostate cancer that is unresponsive or refractory to hormonal therapy AND - Metastatic disease confirmed by bone scan, CT scan, MRI, or X-Ray 9. Have documented disease progression while receiving or following hormonal therapy for treatment of advanced prostate cancer despite castrate levels of serum testosterone due to orchiectomy or luteinizing hormone-releasing hormone (LHRH) agonist as determined by at least one of the following criteria: - Serum PSA level = 2ng/mL that has increased from a reference value (the last value immediately prior to the first rise) on at least two consecutive PSA measurements obtained at least 1 week apart prior to randomization - Progression of measurable disease - Measurable disease is defined as at least one measurable lesion = 10 mm in the longest diameter by CT or MRI (or 20 mm by chest X-ray) and/or lymph nodes = 15 mm short axis - Progression of measurable disease is defined as an increase of = 20% in the sum of the diameters of target lesions from the time of maximal regression with an absolute increase of = 5mm, OR the appearance of = 1 new lesion - Unequivocal progression of non-measurable disease - Non-measurable disease is defined as all lesions < 10mm in the longest diameter or pathological lymph nodes =10 mm to < 15 mm short axis - Unequivocal progression of existing lesions is defined as an increase in overall disease burden based on the change in non-measurable disease that is comparable in magnitude to the increase that would be required to declare disease progression for measurable disease - Two or more new bone lesions as detected by bone scan 10. All subjects: - Must be counseled about pregnancy precautions and risks of fetal exposure. See Appendix 21.7.2 Lenalidomide Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods, and Appendix 21.7.3 Lenalidomide Education and Counseling Guidance Document - Must agree to use a condom during sexual contact with a female of childbearing potential (FCBP), even if they have had a vasectomy, while participating in this study, during dose interruptions, and for a period of 28 days following the last dose of study drug - Must agree to refrain from donating semen or sperm while participating in this study and for a period of 28 days following the last dose of study drug. - Must agree to refrain from donating blood or plasma while participating in this study and for a period of 28 days following the last dose of study drug - Must agree not to share study drug with anyone during participation in the study Are the trial subjects under 18? no Number of subj
Exclusion criteria
Exclusion criteria: 1. A history of clinically significant (as determined by the investigator) medical, surgical, or psychiatric disease that would place the subject at an unacceptable risk for study entry 2. Prior therapy with thalidomide, lenalidomide (CC-5013) or pomalidomide (CC-4047) 3. Prior chemotherapy for prostate cancer - Treatment with estramustine will be allowed if last treatment is more than 28 days prior to randomization, and subject has recovered from side effects - Adjuvant and/or neoadjuvant treatment will be allowed if completed > 3 years prior to randomization and provided the treatment was a non-taxane based regimen 4. Use of any other experimental drug or therapy within 28 days prior to randomization. 5. Prior radiation to = 30% of bone marrow as determined by review of Appendix 21.4 and/or consultation with radiation specialist 6. Any other radiation therapy within 28 days prior to randomization - Subjects receiving prior radiation must have recovered from acute toxicity or any side effects due to radiation treatments prior to randomization 7. Prior use of Strontium-89 at any time or Samarium-153 within 56 days prior to randomization. 8. Surgery within 28 days prior to randomization (minimally invasive procedures for the purpose of diagnosis or staging of the disease are permitted). 9. Concurrent antiandrogen therapy as follows: - Treatment with antiandrogens (e.g., flutamide), aminoglutethimide, megestrol or diethylstilbestrol (DES) must be discontinued at least 4 weeks prior to randomization - Treatment with bicalutamide and nilutamide must be discontinued at least 6 weeks prior to randomization - Subjects exhibiting clinical symptoms and/or radiologic evidence of rapidly progressive disease will be allowed to initiate treatment if in the clinical judgment of the investigator a 4- or 6-week delay for anti-androgen washout would compromise the health and safety of the study subject - Subjects without prior orchiectomy should continue treatment with LHRH agonists or antagonists - Bisphosphonates may be used if treatment was initiated at least 28 days prior to randomization - Concurrent therapy with steroids or hormones for adrenal insufficiency or nondisease-related conditions (e.g., insulin for diabetes) are allowed 10. Any of the following laboratory values: - Hemoglobin 1.0 x ULN - Serum aspartate amino transaminase (AST)/SGOT and/or alanine transaminase (ALT)/SGPT > 1.5 x ULN concomitant with alkaline phosphatase > 2.5 x ULN 11. Must not have had significant active cardiac disease within the previous 6 months including: - History of uncontrolled hypertension (i.e., BP > 160/90 mmHg) despite anti-hypertensive therapy - New York Heart Association class II-IV congestive heart failure - Unstable angina - Myocardial infarction 12. Clinically significant peripheral arterial occlusive disease (i.e., claudication on less than 1 block) 13. Thrombotic or thromboembolic events within the past 6 months, including any of the following: - Deep Vein Thrombosis or Pulmonary Embolism within the preceding 6 months - Transient ischemic attack - Cerebrovascular accident - Any other arterial thrombotic event 14. Current or history of peripheral neuropathy of = grade 2 15. History of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Overall Survival OS is defined as time from randomization to death. All deaths, regardless of the cause of death, will be included. All subjects who are lost to the follow-up prior to the end of the trial or who are withdrawn from the trial will be censored at the time of last contact. Subjects who are still being treated will be censored at the last available date the subject is known to be alive or clinical cut-off date whichever is earlier.;Main Objective: To compare the Overall Survival (OS) benefit of docetaxel and prednisone with and without lenalidomide as first-line therapy in chemo-naïve metastatic Castrate Resistant Prostate Cancer (CRPC) subjects.;Secondary Objective: Progression-Free Survival (PFS) Objective Response Rate Safety of lenalidomide in combination with docetaxel and prednisone;Timepoint(s) of evaluation of this end point: OS will be evaluated from Cycle 1 day 1 until subject death. Subjects will be followed for survival throughout the study treatment and every 90 days after treatment phase discontinuation for up to 5 years or until all subjects have died. An interim efficacy analysis based on OS will be performed when 468 events have occurred and all subjects have been randomized. The final primary analysis for overall survival is planned once 624 events are observed (after aprox 4 years since FPI) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Progression-Free Survival (PFS) •Objective Response Rate •Safety of lenalidomide in combination with docetaxel and prednisone;Timepoint(s) of evaluation of this end point: • PFS: Cycle 1 day 1 until disease progression. PFS will be assessed on Day 1 of each third cycle (starting with Cycle 4, Day 1), and at treatment phase discontinuation. • ORR: Cycle 1 day 1 until best measurable response. Assessments will be scheduled for Day 1 of each third cycle, starting with Cycle 4, Day 1, and at Treatment Phase discontinuation. • Safety: baseline until 28 days after last study dose. Safety review of the study after 100 subjects have completed 2 treatment cycles or prematurely withdrawn from the study. Ongoing safety assessments will be performed every 6 months until the final subject enrolled has completed either 2 treatment cycles or pre-maturely withdrawn from the study | — |
Countries
Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Germany, Greece, Hungary, Israel, Italy, Mexico, Netherlands, Russian Federation, South Africa, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactClinicalTrialDisclosure
Celgene Corporation
Outcome results
None listed