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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03484520
Other study ID # M16-183
Secondary ID 2017-003213-26
Status Terminated
Phase Phase 1
First received
Last updated
Start date July 23, 2018
Est. completion date December 1, 2022

Study information

Verified date December 2022
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Terminated
Enrollment 48
Est. completion date December 1, 2022
Est. primary completion date December 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Drug:
Venetoclax
tablet, oral
Dinaciclib
intravenous

Locations

Country Name City State
Australia Royal Hobart Hospital /ID# 202763 Hobart Tasmania
Australia Monash Medical Centre /ID# 202762 Melbourne Victoria
Australia Gold coast University Hospital /ID# 202759 SouthPort Queensland
Spain Hospital Universitario Ramon y Cajal /ID# 201729 Madrid
Spain Hospital Universitario de Salamanca /ID# 201728 Salamanca
Spain Hospital Universitario y Politecnico La Fe /ID# 202318 Valencia
United States University of Maryland School of Medicine /ID# 204015 Baltimore Maryland
United States The University ofChicago /ID# 200017 Chicago Illinois
United States The Ohio State University /ID# 200668 Columbus Ohio
United States University of Texas MD Anderson Cancer Center /ID# 205215 Houston Texas
United States University of Arkansas /ID# 200016 Little Rock Arkansas
United States David Geffen School of Medicin /ID# 200015 Los Angeles California
United States Wake Forest Baptist Medical Center /ID# 200288 Winston-Salem North Carolina

Sponsors (2)

Lead Sponsor Collaborator
AbbVie Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Australia,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Tmax of Venetoclax Time to maximum plasma concentration (Tmax) of venetoclax. Approximately 29 days after first dose of study drug
Primary Recommended Phase 2 Dose (RPTD) of co-administered Dinaciclib and Venetoclax Tthe RPTD of co-administered venetoclax and dinaciclib will be determined during the dose escalation phase of the study. RPTD will be determined using available safety and pharmacokinetics data. Minimum first cycle of dosing (21 days)
Primary Cmax of Venetoclax Maximum observed plasma concentration (Cmax) for Venetoclax. Approximately 29 days after first dose of study drug
Primary AUCt of Venetoclax Area Under the Plasma Concentration-time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt) Approximately 29 days after first dose of study drug
Primary AUC0-24 Post-dose of Venetoclax Area under the plasma concentration-time curve from 0 to 24 hours (AUC24) post-dose of venetoclax. Approximately 29 days after first dose of study drug
Primary Cmax of Dinaciclib Maximum plasma concentration (Cmax) of dinaciclib. Approximately 29 days after first dose of study drug
Primary Half-life (t1/2) of Dinaciclib Half-life (t1/2) of dinaciclib. Approximately 29 days after first dose of study drug
Primary AUCt Post-dose of Dinaciclib Area under the plasma concentration-time curve from time zero to time t (AUCt) post-dose dinaciclib. Approximately 29 days after first dose of study drug
Primary AUC0-8 of Dinaciclib Area under the plasma concentration-time curve from 0 to infinity (AUC0-8) post-dose of dinaciclib. Approximately 29 days after first dose of study drug
Primary Clearance of Dinaciclib Clearance (CL) of dinaciclib. Approximately 29 days after first dose of study drug
Secondary Complete Response (CR) Rate CR is defined as the proportion of participants with documented complete response (CR) based on International Working Group (IWG) criteria. Up to approximately 18 months
Secondary Composite CR Rate (CR + CRi) Composite is defined as CR + CRi (CR with incomplete blood count recovery) based on IWG criteria. Up to approximately 18 months
Secondary Objective Response Rate (ORR) ORR is defined as the proportion of participants with documented partial response (PR) or better (CR + CRi + partial response [PR]) based on IWG criteria. Up to approximately 18 months