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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003314-41 | EudraCT Number |
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Safety
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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
| Amgen | INDUSTRY |
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This dose-escalation study evaluating the safety, pharmacokinetics and preliminary efficacy of venetoclax in combination with AMG 176 in participants with relapsed or refractory acute myeloid leukemia (AML) and participants with Non-Hodgkin's lymphoma (NHL)/diffuse large B-cell lymphoma (DLBCL).
This study will include a dose escalation phase to identify the maximum tolerated dose/recommended phase 2 dose (MTD/RPTD) of venetoclax plus AMG 176 as well as a dose expansion phase to confirm safety, explore efficacy, and confirm the suitability of the preliminary RPTD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venetoclax + AMG 176 | Experimental | Venetoclax and AMG 176 will be administered in combination. Different combinations of dose levels for venetoclax and AMG 176 will be explored. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venetoclax | Drug | tablet, oral |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RPTD) for Venetoclax + AMG 176 | The MTD and/or RPTD of venetoclax and of AMG 176 will be determined during the dose escalation phase of the study. | Up to 28 days after first dose of study drug in a dose-escalation phase |
| Number of Participants With Adverse Events | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. | From first dose of study drug until 30 days or 5 half-lives after discontinuation of study drug administration will be collected (up to approximately 4 years). |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Complete Remission Rate (CRc) for Participants with AML | CRc rate is defined as CR + CRi (CR with incomplete blood count recovery). | Up to approximately 2 years from last subject first dose |
| Objective Response Rate (ORR) for Participants with AML |
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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 |
|---|---|---|---|---|---|---|
| City of Hope /ID# 207393 | Duarte | California | 91010 | United States | ||
| USC Norris Cancer Center /ID# 207396 |
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| Label | URL |
|---|---|
| Related Info | View source |
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| AMG 176 | Drug | solution, intravenous |
|
ORR is defined as the percentage of participants with documented partial response (PR) or better (CR + CRi + partial response [PR]) based on International Working Group (IWG) criteria for AML |
| Up to approximately 2 years from last subject first dose |
| ORR for Participants with NHL | ORR is defined as the percentage of participants with documented CR + PR based on Lugano criteria for NHL. | Up to approximately 2 years from last subject first dose |
| Maximum Plasma Concentration (Cmax) of Venetoclax | Maximum observed plasma concentration (Cmax) of venetoclax. | Up to approximately 28 days after first dose of study drug |
| Time to Maximum Observed Plasma Concentration (Tmax) of Venetoclax | Time to maximum plasma concentration (Tmax) of Venetoclax. | Up to approximately 28 days after first dose of study drug |
| AUC of Venetoclax | Area under the plasma concentration-time curve (AUC) of venetoclax. | Up to approximately 28 days after first dose of study drug |
| Maximum Plasma Concentration (Cmax) of AMG 176 | Maximum observed plasma concentration (Cmax) of AMG 176 | Up to approximately 16 days after first dose of study drug |
| Half-life (t1/2) of AMG 176 | Terminal phase elimination half-life (t1/2) | Approximately 16 days after first dose of study drug |
| AUC of AMG 176 | Area Under the Plasma Concentration-time Curve (AUC) of AMG 176 | Approximately 16 days after first dose of study drug |
| Clearance (CL) of AMG 176 | Clearance (CL) is defined the volume of plasma cleared of the drug per unit time. | Approximately 16 days after first dose of study drug |
| Los Angeles |
| California |
| 90033 |
| United States |
| University of Iowa Hospitals and Clinics /ID# 207459 | Iowa City | Iowa | 52242 | United States |
| Univ Kansas Med Ctr /ID# 207480 | Kansas City | Kansas | 66160 | United States |
| Duplicate_Dana-Farber Cancer Institute /ID# 207367 | Boston | Massachusetts | 02215 | United States |
| Washington University-School of Medicine /ID# 206995 | St Louis | Missouri | 63110 | United States |
| NYU Langone Medical Center /ID# 207390 | New York | New York | 10016-6402 | United States |
| Unc /Id# 207388 | Chapel Hill | North Carolina | 27599 | United States |
| UPMC Hillman Cancer Ctr /ID# 208482 | Pittsburgh | Pennsylvania | 15232 | United States |
| Calvary Mater Newcastle /ID# 211455 | Waratah | New South Wales | 2298 | Australia |
| Royal Adelaide Hospital /ID# 210602 | Adelaide | South Australia | 5000 | Australia |
| Alfred Health /ID# 210350 | Melbourne | Victoria | 3004 | Australia |
| Universitaetsklinikum Frankfurt /ID# 207984 | Frankfurt am Main | Hesse | 60590 | Germany |
| Universitaetsklinikum Leipzig /ID# 209824 | Leipzig | Saxony | 04103 | Germany |
| Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 207987 | Berlin | 13353 | Germany |
| Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 207803 | Dresden | 01307 | Germany |
| Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 207788 | Hamburg | 20246 | Germany |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D008228 | Lymphoma, Non-Hodgkin |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008223 | Lymphoma |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D016393 | Lymphoma, B-Cell |
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| ID | Term |
|---|---|
| C579720 | venetoclax |
| C000720001 | tapotoclax |
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