A Phase 3 study to evaluate the efficacy and safety of docetaxel and prednisone with or without lenalidomide in subjects with castrate-resistant prostate cancer.
- Conditions
- prostate cancer that can't be treated surgically1003859710036958
- Registration Number
- NL-OMON43687
- Lead Sponsor
- Celgene Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 136
Amendment 3: screening and recruitment was completed under protocol amendment 2. Below are criteria from Am2.;Subjects Must Meet All of the Following Inclusion Criteria to be Eligible for Enrollment Into The Study:
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, Computer Tomography (CT) scan, Magnetic Resonance Imaging (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 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
And by 2 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 (specified in the appropriate country specific appendix) 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
Amendment 3: screening and recruitment was completed under protocol amendment 2. Below are criteria from Am2.;Key Exclusion Criteria
Presence of any of the Following will Exclude a Subject from Enrollment into the Study:
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 consulation 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 antiadrogen 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 < 9 g/dL
* Absolute neutrophil count (ANC) < 1.5 x 109 cells/L
* Platelet count < 100 x 109 cells/L
* Creatinine clearance <50mL/min by Cockcroft-Gault formula
* Total bilirubin > 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 mm Hg) 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method