A Study of Venetoclax and Dinaciclib (MK7965) in Patients With Relapsed/Refractory Acute Myeloid Leukemia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03484520|
Recruitment Status : Terminated (Strategic considerations)
First Posted : March 30, 2018
Last Update Posted : December 30, 2022
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Cancer - Acute Myeloid Leukemia||Drug: Venetoclax Drug: Dinaciclib||Phase 1|
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1b Study of Venetoclax and Dinaciclib (MK7965) in Patients With Relapsed/Refractory Acute Myeloid Leukemia|
|Actual Study Start Date :||July 23, 2018|
|Actual Primary Completion Date :||December 1, 2022|
|Actual Study Completion Date :||December 1, 2022|
Experimental: Venetoclax + Dinaciclib
Venetoclax and dinaciclib will be administered in combination. Different combinations of dose levels for venetoclax and dinaciclib will be explored.
- Tmax of Venetoclax [ Time Frame: Approximately 29 days after first dose of study drug ]Time to maximum plasma concentration (Tmax) of venetoclax.
- Recommended Phase 2 Dose (RPTD) of co-administered Dinaciclib and Venetoclax [ Time Frame: Minimum first cycle of dosing (21 days) ]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.
- Cmax of Venetoclax [ Time Frame: Approximately 29 days after first dose of study drug ]Maximum observed plasma concentration (Cmax) for Venetoclax.
- AUCt of Venetoclax [ Time Frame: Approximately 29 days after first dose of study drug ]Area Under the Plasma Concentration-time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt)
- AUC0-24 Post-dose of Venetoclax [ Time Frame: Approximately 29 days after first dose of study drug ]Area under the plasma concentration-time curve from 0 to 24 hours (AUC24) post-dose of venetoclax.
- Cmax of Dinaciclib [ Time Frame: Approximately 29 days after first dose of study drug ]Maximum plasma concentration (Cmax) of dinaciclib.
- Half-life (t1/2) of Dinaciclib [ Time Frame: Approximately 29 days after first dose of study drug ]Half-life (t1/2) of dinaciclib.
- AUCt Post-dose of Dinaciclib [ Time Frame: Approximately 29 days after first dose of study drug ]Area under the plasma concentration-time curve from time zero to time t (AUCt) post-dose dinaciclib.
- AUC0-∞ of Dinaciclib [ Time Frame: Approximately 29 days after first dose of study drug ]Area under the plasma concentration-time curve from 0 to infinity (AUC0-∞) post-dose of dinaciclib.
- Clearance of Dinaciclib [ Time Frame: Approximately 29 days after first dose of study drug ]Clearance (CL) of dinaciclib.
- Complete Response (CR) Rate [ Time Frame: Up to approximately 18 months ]CR is defined as the proportion of participants with documented complete response (CR) based on International Working Group (IWG) criteria.
- Composite CR Rate (CR + CRi) [ Time Frame: Up to approximately 18 months ]Composite is defined as CR + CRi (CR with incomplete blood count recovery) based on IWG criteria.
- Objective Response Rate (ORR) [ Time Frame: Up to approximately 18 months ]ORR is defined as the proportion of participants with documented partial response (PR) or better (CR + CRi + partial response [PR]) based on IWG criteria.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03484520
|United States, Arkansas|
|University of Arkansas /ID# 200016|
|Little Rock, Arkansas, United States, 72205|
|United States, California|
|David Geffen School of Medicin /ID# 200015|
|Los Angeles, California, United States, 90095|
|United States, Illinois|
|The University ofChicago /ID# 200017|
|Chicago, Illinois, United States, 60637|
|United States, Maryland|
|University of Maryland School of Medicine /ID# 204015|
|Baltimore, Maryland, United States, 21201-1544|
|United States, North Carolina|
|Wake Forest Baptist Medical Center /ID# 200288|
|Winston-Salem, North Carolina, United States, 27157-0001|
|United States, Ohio|
|The Ohio State University /ID# 200668|
|Columbus, Ohio, United States, 43210|
|United States, Texas|
|University of Texas MD Anderson Cancer Center /ID# 205215|
|Houston, Texas, United States, 77030|
|Gold coast University Hospital /ID# 202759|
|SouthPort, Queensland, Australia, 4215|
|Royal Hobart Hospital /ID# 202763|
|Hobart, Tasmania, Australia, 7000|
|Monash Medical Centre /ID# 202762|
|Melbourne, Victoria, Australia, 3168|
|Hospital Universitario Ramon y Cajal /ID# 201729|
|Madrid, Spain, 28034|
|Hospital Universitario de Salamanca /ID# 201728|
|Salamanca, Spain, 37711|
|Hospital Universitario y Politecnico La Fe /ID# 202318|
|Valencia, Spain, 46026|
|Study Director:||ABBVIE INC.||AbbVie|
|Other Study ID Numbers:||
2017-003213-26 ( EudraCT Number )
|First Posted:||March 30, 2018 Key Record Dates|
|Last Update Posted:||December 30, 2022|
|Last Verified:||December 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
Cancer, Acute Myeloid Leukemia (AML), venetoclax, dinaciclib, Relapsed/refractory AML, Pharmacokinetics, Venetoclax, Dinaciclib
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type