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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01580228
Other study ID # P07714
Secondary ID 2011-005186-20
Status Completed
Phase Phase 3
First received April 3, 2012
Last updated February 17, 2017
Start date August 2012
Est. completion date December 2014

Study information

Verified date February 2017
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Ghia P, Scarfò L, Perez S, Pathiraja K, Derosier M, Small K, Sisk CM, Patton N. Efficacy and safety of dinaciclib versus ofatumumab in patients with relapsed/refractory chronic lymphocytic leukemia. Blood. 2017 Jan 26. pii: blood-2016-10-748210. doi: 10.1 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Participant Progression Free Survival From date of randomization up to approximately 38 months
Secondary Participant Overall Response Rate From date of randomization up to approximately 38 months
Secondary Participant Overall Survival Rate From date of randomization until up to approximately 50 months
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