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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03484520|
Recruitment Status : Recruiting
First Posted : March 30, 2018
Last Update Posted : June 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cancer - Acute Myeloid Leukemia||Drug: Venetoclax Drug: Dinaciclib||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 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|
|Estimated Primary Completion Date :||January 21, 2020|
|Estimated Study Completion Date :||October 5, 2021|
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.
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
|Contact: ABBVIE CALL CENTERfirstname.lastname@example.org|
|United States, Arkansas|
|University of Arkansas /ID# 200016||Not yet recruiting|
|Little Rock, Arkansas, United States, 72205|
|United States, California|
|David Geffen School of Medicin /ID# 200015||Recruiting|
|Los Angeles, California, United States, 90095|
|Cedars-Sinai Medical Center - West Hollywood /ID# 202245||Not yet recruiting|
|West Hollywood, California, United States, 90048|
|United States, Illinois|
|The University of Chicago /ID# 200017||Recruiting|
|Chicago, Illinois, United States, 60637|
|United States, Maryland|
|Univ Maryland School Medicine /ID# 204015||Recruiting|
|Baltimore, Maryland, United States, 21201|
|United States, North Carolina|
|Wake Forest Baptist Medical Center /ID# 200288||Recruiting|
|Winston-Salem, North Carolina, United States, 27157-0001|
|United States, Ohio|
|The Ohio State University - Columbus /ID# 200668||Recruiting|
|Columbus, Ohio, United States, 43210|
|United States, Texas|
|Univ TX, MD Anderson /ID# 205215||Not yet recruiting|
|Houston, Texas, United States, 77030|
|Gold Coast University Hospital /ID# 202759||Recruiting|
|Southport, Queensland, Australia, 4215|
|Royal Hobart Hospital /ID# 202763||Recruiting|
|Hobart, Tasmania, Australia, 7000|
|Monash Medical Centre /ID# 202762||Recruiting|
|Melbourne, Victoria, Australia, 3168|
|Hospital Universitario y Politecnico La Fe /ID# 202318||Recruiting|
|Valencia, Valenciana, Spain, 46026|
|Hospital Ramon y Cajal /ID# 201729||Recruiting|
|Madrid, Spain, 28036|
|Hospital Clinico Univ de Salamanca /ID# 201728||Recruiting|
|Salamanca, Spain, 37007|
|Study Director:||AbbVie Inc.||AbbVie|