Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2017-002531-42 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Sumitomo Pharma America, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
An open-label, dose-escalation study to assess the safety and pharmacokinetics (PK), to determine the dose limiting toxicity (DLT) and the recommended Phase 2 dose (RPTD), and to assess the preliminary efficacy of alvocidib with venetoclax when co-administered in participants with relapsed or refractory (R/R) acute myeloid leukemia (AML).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venetoclax + Alvocidib | Experimental | Venetoclax administered orally once daily (QD) and Alvocidib administered as an intravenous infusion on Days 1, 2, and 3 for all 28-day treatment cycles. Different combinations of dose levels for venetoclax and alvocidib may be explored. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venetoclax | Drug | tablet, oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Tmax of venetoclax | Time to maximum plasma concentration (Tmax) of venetoclax | Approximately 32 days after first dose of study drug |
| Clearance of Alvocidib | Clearance (CL) of alvocidib | Approximately 32 days after first dose of study drug |
| AUC0-∞ of Alvocidib | Area under the plasma concentration-time curve from 0 to infinity (AUC0-∞) post-dose of alvocidib | Approximately 32 days after first dose of study drug |
| Cmax of Venetoclax | Maximum plasma concentration (Cmax) of venetoclax | Approximately 32 days after first dose of study drug |
| Half-life (t1/2) of Alvocidib | Half-life (t1/2) of alvocidib | Approximately 32 days after first dose of study drug |
| AUC0-24 Post-dose of Venetoclax | Area under the plasma concentration-time curve from 0 to 24 hours (AUC24) post-dose of venetoclax. | Approximately 32 days after first dose of study drug |
| Cmax of Alvocidib | Maximum plasma concentration (Cmax) of alvocidib. | Approximately 32 days after first dose of study drug |
| AUCt Post-dose of Alvocidib |
| Measure | Description | Time Frame |
|---|---|---|
| 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 8 months |
| Combined CR Rate |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC Norris Cancer Center /ID# 170844 | Los Angeles | California | 90033 | United States | ||
| UC Irvine /ID# 201093 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Alvocidib | Drug | Intravenous |
|
|
Area under the plasma concentration-time curve from time zero to time t (AUCt) post-dose alvocidib.
| Approximately 32 days after first dose of study drug |
| Dose Escalation Phase: Recommended Phase 2 dose (RPTD) for Venetoclax and Alvocidib | RPTD will be determined using available safety and pharmacokinetics data upon completion of the dose escalation phase. | Minimum first cycle of dosing (up to 28 days) |
Combined CR rate is defined as CR + CRi (CR with incomplete blood count recovery) based on IWG criteria.
| Up to approximately 8 months |
| Objective Response Rate (ORR) | ORR is defined as the proportion of participants with documented partial response (PR) or better based on IWG criteria. | Up to approximately 18 months |
| Orange |
| California |
| 92868 |
| United States |
| University of California, Davis Comprehensive Cancer Center /ID# 170799 | Sacramento | California | 95817 | United States |
| Sylvester Comprehensive Cancer /ID# 170761 | Miami | Florida | 33136-1002 | United States |
| Indiana Blood & Marrow Transpl /ID# 170793 | Indianapolis | Indiana | 46237 | United States |
| NYU Langone Medical Center /ID# 201559 | New York | New York | 10016-6402 | United States |
| Weill Cornell Medical College /ID# 170800 | New York | New York | 10021 | United States |
| Duke University Medical Center /ID# 170842 | Durham | North Carolina | 27710-3000 | United States |
| University of Pittsburgh Medic /ID# 170790 | Pittsburgh | Pennsylvania | 15261 | United States |
| Universitaetsklinikum Dresden /ID# 168636 | Dresden | 01307 | Germany |
| Univ Klinik Eppendorf Hamburg /ID# 168633 | Hamburg | 20246 | Germany |
| University Hospital of Wales /ID# 202302 | Cardiff | CF14 4EN | United Kingdom |
| Ninewells Hospital /ID# 202304 | Dundee | DD1 9SY | United Kingdom |
| St. James University Hospital /ID# 202303 | Leeds | LS9 7TF | United Kingdom |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C579720 | venetoclax |
| C077990 | alvocidib |
Not provided
Not provided
Not provided