ClinicalTrials.gov

History of Changes for Study: NCT00988208
Study to Evaluate Safety and Effectiveness of Lenalidomide in Combination With Docetaxel and Prednisone for Patients With Castrate-Resistant Prostate Cancer (Mainsail)
Latest version (submitted March 9, 2018) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 October 1, 2009 None (earliest Version on record)
2 November 18, 2009 Recruitment Status, Study Status, Contacts/Locations and Oversight
3 December 3, 2009 Contacts/Locations and Study Status
4 December 29, 2009 Contacts/Locations and Study Status
5 January 11, 2010 Study Status and Contacts/Locations
6 February 4, 2010 Study Status and Contacts/Locations
7 February 12, 2010 Contacts/Locations and Study Status
8 March 10, 2010 Study Status and Contacts/Locations
9 March 16, 2010 Contacts/Locations and Study Status
10 March 31, 2010 Contacts/Locations and Study Status
11 April 15, 2010 Contacts/Locations and Study Status
12 May 6, 2010 Contacts/Locations and Study Status
13 May 27, 2010 Study Status
14 June 9, 2010 Contacts/Locations and Study Status
15 June 11, 2010 Contacts/Locations and Study Status
16 June 23, 2010 Contacts/Locations and Study Status
17 August 3, 2010 Contacts/Locations and Study Status
18 August 5, 2010 Contacts/Locations and Study Status
19 September 1, 2010 Study Status and Contacts/Locations
20 November 2, 2010 Contacts/Locations and Study Status
21 November 9, 2010 Contacts/Locations and Study Status
22 December 13, 2010 Contacts/Locations and Study Status
23 January 26, 2011 Contacts/Locations, Study Status, Eligibility, Study Description and Sponsor/Collaborators
24 February 17, 2011 Contacts/Locations and Study Status
25 March 8, 2011 Contacts/Locations, Study Status and Sponsor/Collaborators
26 April 20, 2011 Study Status and Contacts/Locations
27 April 25, 2011 Contacts/Locations and Study Status
28 May 26, 2011 Contacts/Locations and Study Status
29 July 20, 2011 Contacts/Locations and Study Status
30 August 10, 2011 Contacts/Locations, Study Status and Sponsor/Collaborators
31 August 11, 2011 Contacts/Locations and Study Status
32 October 11, 2011 Sponsor/Collaborators, Contacts/Locations and Study Status
33 October 31, 2011 Recruitment Status, Study Status and Contacts/Locations
34 May 14, 2012 Study Status
35 September 27, 2012 Arms and Interventions, Study Status, Outcome Measures, Study Design, Eligibility, Conditions and Study Description
36 June 27, 2013 Study Status, Outcome Measures and Results
37 September 4, 2013 Study Status and Participant Flow
38 March 17, 2014 Study Status and Baseline Characteristics
39 July 8, 2014 Contacts/Locations, Study Status and Study Identification
40 April 29, 2015 Contacts/Locations, Study Status and Study Design
41 June 8, 2015 Study Status, Contacts/Locations and Study Design
42 August 12, 2015 Study Status and Contacts/Locations
43 October 30, 2015 Study Status
44 December 23, 2015 Study Status
45 April 1, 2016 Study Status, Study Identification and Contacts/Locations
46 April 22, 2016 Study Status
47 July 5, 2016 Study Status
48 September 12, 2016 Study Status
49 April 4, 2017 Recruitment Status, Study Status, Sponsor/Collaborators, Study Identification, Outcome Measures and References
50 November 28, 2017 Adverse Events, Outcome Measures, Baseline Characteristics, Participant Flow, Contacts/Locations, Study Status and References
51 March 9, 2018 Baseline Characteristics, Outcome Measures, Study Status
Comparison Format:

Scroll up to access the controls

Study NCT00988208
Submitted Date:  October 1, 2009 (v1)

Open or close this module Study Identification
Unique Protocol ID: CC-5013-PC-002
Brief Title: Study to Evaluate Safety and Effectiveness of Lenalidomide in Combination With Docetaxel and Prednisone for Patients With Castrate-Resistant Prostate Cancer (Mainsail)
Official Title: 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
Secondary IDs: EudraCT Number 2008-007969-23
Open or close this module Study Status
Record Verification: October 2009
Overall Status: Not yet recruiting
Study Start: November 2009
Primary Completion: November 2013 [Anticipated]
Study Completion: October 2017 [Anticipated]
First Submitted: October 1, 2009
First Submitted that
Met QC Criteria:
October 1, 2009
First Posted: October 2, 2009 [Estimate]
Last Update Submitted that
Met QC Criteria:
October 1, 2009
Last Update Posted: October 2, 2009 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Celgene Corporation
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary:

The purpose of the study is to determine whether lenalidomide is safe and effective in combination with docetaxel and prednisone for the treatment of subjects with metastatic Castrate-Resistant Prostate Cancer.

The addition of lenalidomide to docetaxel and prednisone is proposed to increase the life expectancy of these subjects.

Detailed Description:
Open or close this module Conditions
Conditions: Castrate-Resistant Prostate Cancer
Keywords: Castrate-Resistant Prostate Cancer
Revlimid
Lenalidomide
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 1015 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: DPL treatment arm
25 mg lenalidomide orally once each day (QD) on Days 1-14; 75 mg/m^2 docetaxel IV on Day 1; 5 mg prednisone orally twice each day (BID) on each day of the treatment cycle
Drug: Lenalidomide (CC-5013) 10mg, 15mg, 20mg, 25mg and their respective matching placebo capsules for oral administration

DP treatment arm: Oral placebo once each day (QD) on Days 1-14 of the treatment cycle; 75 mg/m^2 docetaxel IV on Day 1; 5 mg prednisone orally twice each day (BID) on each day of the treatment cycle

DPL treatment arm: 25 mg lenalidomide orally once each day (QD) on Days 1-14; 75 mg/m^2 docetaxel IV on Day 1; 5 mg prednisone orally twice each day (BID) on each day of the treatment cycle

Other Names:
  • Lenalidomide: Revlimid
  • Docetaxel: Taxotere
  • Prednisone: there are multiple brand names for prednisone
Experimental: DP treatment arm
Oral placebo once each day (QD) on Days 1-14 of the treatment cycle; 75 mg/m^2 docetaxel IV on Day 1; 5 mg prednisone orally twice each day (BID) on each day of the treatment cycle
Drug: Lenalidomide (CC-5013) 10mg, 15mg, 20mg, 25mg and their respective matching placebo capsules for oral administration

DP treatment arm: Oral placebo once each day (QD) on Days 1-14 of the treatment cycle; 75 mg/m^2 docetaxel IV on Day 1; 5 mg prednisone orally twice each day (BID) on each day of the treatment cycle

DPL treatment arm: 25 mg lenalidomide orally once each day (QD) on Days 1-14; 75 mg/m^2 docetaxel IV on Day 1; 5 mg prednisone orally twice each day (BID) on each day of the treatment cycle

Other Names:
  • Lenalidomide: Revlimid
  • Docetaxel: Taxotere
  • Prednisone: there are multiple brand names for prednisone
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Overall Survival
[ Time Frame: Cycle 1 Day 1 until subject death ]

Secondary Outcome Measures:
1. Progression-Free Survival (PFS)
[ Time Frame: Cycle 1 day 1 until disease progression ]

2. Objective Response Rate
[ Time Frame: Cycle 1 day 1 until best measurable response ]

3. Safety of lenalidomide in combination with docetaxel and prednisone
[ Time Frame: baseline until 28 days after last study dose ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: Male
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  1. Must sign an Informed Consent Form (ICF)
  2. Males ≥ 18 years of age
  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 Patient-Reported Outcomes assessments
  7. Serum testosterone levels < 50 ng/dL
  8. Confirmed metastatic adenocarcinoma of the prostate that is unresponsive or refractory to hormonal therapy
  9. Have documented disease progression while receiving or following hormonal therapy as determined by increasing Serum PSA level, Radiological Progression, or ≥2 new bone lesions
  10. Subjects must agree to receive counseling related to pregnancy precautions, teratogenic and other risks of lenalidomide
  11. Refrain from donating blood or semen as defined by protocol

Exclusion Criteria:

  1. A history of clinically significant disease that places subject at an unacceptable risk for study entry
  2. Prior Therapy with thalidomide, lenalidomide or pomalidomide
  3. Prior chemotherapy for prostate cancer
  4. Use of any other experimental drug or therapy within 28 days prior to randomization
  5. Prior whole pelvic radiation therapy or any radiation therapy within 28 days prior to randomization
  6. Prior use of Strontium-89 at any time or Samarium-153 within 56 days prior to randomization
  7. Surgery within 28 days prior to randomization
  8. Concurrent corticosteroid or hormonal therapy
  9. Abnormal serum chemistry or hematology laboratory values
  10. Significant active cardiac disease within the previous 6 months:
  11. Thrombotic or thromboembolic events within the past 6 months:
  12. History of peripheral neuropathy of ≥grade 2
  13. History of severe hypersensitivity reaction to drugs formulated with polysorbate 80
  14. Paraplegia
  15. History of Central nervous system (CNS) or brain metastases
  16. History of malignancies other than prostate cancer within the past 5 years, with the exception of treated basal cell/squamous cell carcinoma of the skin
  17. Concurrent use of alternative cancer therapies
Open or close this module Contacts/Locations
Central Contact Person: Brian A Tozzi, MS
Telephone: +1-908-673-9550
Email: mainsail@celgene.com
Study Officials: Mark Jones, MD
Study Director
Celgene Corporation
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services