Clinical trial NCT03484520: A Study of Venetoclax and Dinaciclib (MK7965) in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Official title: Phase 1b Study of Venetoclax and Dinaciclib (MK7965) in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Cancer - Acute Myeloid Leukemia
Keywords: Cancer, Acute Myeloid Leukemia (AML), venetoclax, dinaciclib, Relapsed/refractory AML, Pharmacokinetics, Venetoclax, Dinaciclib
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2018-03-30
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An open-label, dose-escalation study to assess safety, pharmacokinetics and efficacy as well as determine the recommended Phase 2 doses of co-administered therapy of dinaciclib and venetoclax for patients with relapsed or refractory Acute Myeloid Leukemia (R/R AML).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of acute myeloid leukemia (AML) by World Health Organization criteria excluding acute promyelocytic leukemia (APL)-M3.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
* Participant must have adequate hematologic, renal, and liver function laboratory values as described in the protocol.

Exclusion Criteria:

* Known central nervous system leukemia
* Severe chronic obstructive pulmonary disease (COPD) with hypoxemia
* History of any malignancy within the last 6 months except for those specified in this protocol and low-grade malignancies not requiring active treatment.
* Prior allogeneic stem cell transplant within 6 months of study drug administration and no requirement for graft versus host therapy.
* History of clinically significant medical condition that, in the opinion of the investigator, would adversely affect participation in this study.
* Known active infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
* History of tumor lysis syndrome (TLS) due to previous exposure to venetoclax.

Primary outcomes:
measure: Tmax of Venetoclax
timeFrame: Approximately 29 days after first dose of study drug
measure: Recommended Phase 2 Dose (RPTD) of co-administered Dinaciclib and Venetoclax
timeFrame: Minimum first cycle of dosing (21 days)
measure: Cmax of Venetoclax
timeFrame: Approximately 29 days after first dose of study drug
measure: AUCt of Venetoclax
timeFrame: Approximately 29 days after first dose of study drug
measure: AUC0-24 Post-dose of Venetoclax
timeFrame: Approximately 29 days after first dose of study drug
measure: Cmax of Dinaciclib
timeFrame: Approximately 29 days after first dose of study drug
measure: Half-life (t1/2) of Dinaciclib
timeFrame: Approximately 29 days after first dose of study drug
measure: AUCt Post-dose of Dinaciclib
timeFrame: Approximately 29 days after first dose of study drug
measure: AUC0-∞ of Dinaciclib
timeFrame: Approximately 29 days after first dose of study drug
measure: Clearance of Dinaciclib
timeFrame: Approximately 29 days after first dose of study drug
Secondary outcomes:
measure: Complete Response (CR) Rate
timeFrame: Up to approximately 18 months
measure: Composite CR Rate (CR + CRi)
timeFrame: Up to approximately 18 months
measure: Objective Response Rate (ORR)
timeFrame: Up to approximately 18 months
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas /ID# 200016
state: Arkansas
city: Los Angeles
country: United States
facility: David Geffen School of Medicin /ID# 200015
state: California
city: Chicago
country: United States
facility: The University ofChicago /ID# 200017
state: Illinois
city: Baltimore
country: United States
facility: University of Maryland School of Medicine /ID# 204015
state: Maryland
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center /ID# 200288
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University /ID# 200668
state: Ohio
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center /ID# 205215
state: Texas
city: SouthPort
country: Australia
facility: Gold coast University Hospital /ID# 202759
state: Queensland
city: Hobart
country: Australia
facility: Royal Hobart Hospital /ID# 202763
state: Tasmania
city: Melbourne
country: Australia
facility: Monash Medical Centre /ID# 202762
state: Victoria
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal /ID# 201729
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca /ID# 201728
city: Valencia
country: Spain
facility: Hospital Universitario y Politecnico La Fe /ID# 202318
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: