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A Phase 3 Study Comparing Dinaciclib Versus Ofatumumab in Patients With Refractory Chronic Lymphocytic Leukemia (P07714 AM2)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01580228
First received: April 3, 2012
Last updated: September 26, 2014
Last verified: September 2014

April 3, 2012
September 26, 2014
August 2012
December 2014   (final data collection date for primary outcome measure)
Participant Progression Free Survival [ Time Frame: From date of randomization up to approximately 38 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01580228 on ClinicalTrials.gov Archive Site
  • Participant Overall Response Rate [ Time Frame: From date of randomization up to approximately 38 months ] [ Designated as safety issue: No ]
  • Participant Overall Survival Rate [ Time Frame: From date of randomization until up to approximately 50 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Phase 3 Study Comparing Dinaciclib Versus Ofatumumab in Patients With Refractory Chronic Lymphocytic Leukemia (P07714 AM2)
A Phase 3 Study to Evaluate the Efficacy and Safety of Dinaciclib or Ofatumumab in Subjects With Refractory Chronic Lymphocytic Leukemia

This study is being conducted to demonstrate the superiority in progression-free survival (PFS) of dinaciclib compared to ofatumumab in chronic lymphocytic leukemia (CLL) participants with del 17p or in the overall population who are refractory to either fludarabine treatment or chemoimmunotherapy.

Dinaciclib is a cyclin-dependent kinase (CDK) inhibitor, specific for CDK 1, 2, 5 and 9.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Lymphocytic Leukemia (CLL)
  • Drug: Dinaciclib
    Dinaciclib administered intravenously over 2 hours at a dose of 7 mg/m^2 on Day 1, 10 mg/m^2 on Day 8, and 14 mg/m^2 on Day 15 in Cycle 1. Starting in Cycle 2 and thereafter, dinaciclib will be dosed at 14 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle for a total of 12 cycles.
    Other Names:
    • SCH-727965
    • MK-7965
  • Drug: Ofatumumab
    Ofatumumab administered intravenously at a dose of 300 mg on Cycle 1 Day 1, followed by 2000 mg on Cycle 1 Days 8, 15, and 22; Cycle 2 Days 1, 8, 15, and 22; followed 5 weeks later on Day 1 of Cycles 4-12.
    Other Name: Arzerra
  • Experimental: Dinaciclib
    Intervention: Drug: Dinaciclib
  • Active Comparator: Ofatumumab
    Intervention: Drug: Ofatumumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
466
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Aged 18 years or older
  • Confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL)
  • Fludarabine or chemoimmunotherapy refractory disease defined as: failing to respond to or relapsed within 6 months of completing fludarabine or another purine analog alone or in combination regimens, or failing to respond to chemoimmunotherapy or relapsed within 24 months of completing therapy with a combination of chemotherapy plus an anti-CD20 monoclonal antibody
  • Eastern Cooperative Oncology Group (ECOG) Performance status 0, 1, or 2
  • Adequate organ function and laboratory parameters
  • Women of child-bearing potential who are not currently sexually active must

agree to use a medically accepted method of contraception should they become

sexually active while participating in the study

Exclusion Criteria:

  • Symptomatic brain metastases or primary central nervous system malignancy
  • Treatment with a CYP3A4 inhibitor or inducer within 1 week prior to randomization, or any chemotherapy or biologic therapy within 4 weeks prior to randomization
  • Known human immunodeficiency virus (HIV) infection or a known HIV-related

malignancy

  • Participants with with clinically active hepatitis B or C defined as disease that requires therapy
  • Positive test for glucose-6 phosphate dehydrogenase (G6PD) deficiency
  • Prior allogeneic bone marrow transplant
  • Presence of Richter's transformation
  • Indeterminate deletion 17p status
  • Previous treatment with ofatumumab, dinaciclib, or other CDK inhibitors
  • Active autoimmune anemia or thrombocytopenia unless stable, which is defined as being responsive to corticosteroids or other standard therapy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01580228
P07714, 2011-005186-20
Yes
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP