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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-003213-26 | EudraCT Number |
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Strategic considerations
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venetoclax + Dinaciclib | Experimental | Venetoclax and dinaciclib will be administered in combination. Different combinations of dose levels for venetoclax and dinaciclib will be explored. |
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| 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 29 days after first dose of study drug |
| 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) |
| Cmax of Venetoclax | Maximum observed plasma concentration (Cmax) for Venetoclax. | Approximately 29 days after first dose of study drug |
| 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 |
| 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 |
| Cmax of Dinaciclib | Maximum plasma concentration (Cmax) of dinaciclib. | Approximately 29 days after first dose of study drug |
| Half-life (t1/2) of Dinaciclib | Half-life (t1/2) of dinaciclib. |
| 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 18 months |
| Composite CR Rate (CR + CRi) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas /ID# 200016 | Little Rock | Arkansas | 72205 | United States | ||
| David Geffen School of Medicin /ID# 200015 |
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| Dinaciclib | Drug | intravenous |
|
|
| Approximately 29 days after first dose of study drug |
| 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 |
| AUC0-∞ of Dinaciclib | Area under the plasma concentration-time curve from 0 to infinity (AUC0-∞) post-dose of dinaciclib. | Approximately 29 days after first dose of study drug |
| Clearance of Dinaciclib | Clearance (CL) of dinaciclib. | Approximately 29 days after first dose of study drug |
Composite is defined as CR + CRi (CR with incomplete blood count recovery) based on IWG criteria.
| Up to approximately 18 months |
| 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 |
| Los Angeles |
| California |
| 90095 |
| United States |
| The University ofChicago /ID# 200017 | Chicago | Illinois | 60637 | United States |
| University of Maryland School of Medicine /ID# 204015 | Baltimore | Maryland | 21201-1544 | United States |
| Wake Forest Baptist Medical Center /ID# 200288 | Winston-Salem | North Carolina | 27157-0001 | United States |
| The Ohio State University /ID# 200668 | Columbus | Ohio | 43210 | United States |
| University of Texas MD Anderson Cancer Center /ID# 205215 | Houston | Texas | 77030 | United States |
| Gold coast University Hospital /ID# 202759 | Southport | Queensland | 4215 | Australia |
| Royal Hobart Hospital /ID# 202763 | Hobart | Tasmania | 7000 | Australia |
| Monash Medical Centre /ID# 202762 | Melbourne | Victoria | 3168 | Australia |
| Hospital Universitario Ramon y Cajal /ID# 201729 | Madrid | 28034 | Spain |
| Hospital Universitario de Salamanca /ID# 201728 | Salamanca | 37711 | Spain |
| Hospital Universitario y Politecnico La Fe /ID# 202318 | Valencia | 46026 | Spain |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D015470 | Leukemia, Myeloid, Acute |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C579720 | venetoclax |
| C553669 | dinaciclib |
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