Cancer - Acute Myeloid Leukemia Clinical Trial
Official title:
Phase 1b Study of Venetoclax and Dinaciclib (MK7965) in Patients With Relapsed/Refractory Acute Myeloid Leukemia
| Verified date | December 2022 |
| Source | AbbVie |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| 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. |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| AbbVie | Merck Sharp & Dohme LLC |
United States, Australia, Spain,
| 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 |