Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 201 for:    Venetoclax

A Study of Venetoclax and AMG 176 in Patients With Relapsed/Refractory Hematologic Malignancies

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03797261
Recruitment Status : Suspended (Suspended to evaluate safety)
First Posted : January 9, 2019
Last Update Posted : October 1, 2019
Sponsor:
Collaborators:
Genentech, Inc.
Amgen
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE January 7, 2019
First Posted Date  ICMJE January 9, 2019
Last Update Posted Date October 1, 2019
Actual Study Start Date  ICMJE March 15, 2019
Estimated Primary Completion Date September 2, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 7, 2019)
  • Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RPTD) for Venetoclax + AMG 176 [ Time Frame: Up to 28 days after first dose of study drug in a dose-escalation phase ]
    The MTD and/or RPTD of venetoclax and of AMG 176 will be determined during the dose escalation phase of the study.
  • Number of Participants With Adverse Events [ Time Frame: 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). ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03797261 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 7, 2019)
  • Composite Complete Remission Rate (CRc) for Participants with AML [ Time Frame: Up to approximately 2 years from last subject first dose ]
    CRc rate is defined as CR + CRi (CR with incomplete blood count recovery).
  • Objective Response Rate (ORR) for Participants with AML [ Time Frame: Up to approximately 2 years from last subject first dose ]
    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
  • ORR for Participants with NHL [ Time Frame: Up to approximately 2 years from last subject first dose ]
    ORR is defined as the percentage of participants with documented CR + PR based on Lugano criteria for NHL.
  • Maximum Plasma Concentration (Cmax) of Venetoclax [ Time Frame: Up to approximately 28 days after first dose of study drug ]
    Maximum observed plasma concentration (Cmax) of venetoclax.
  • Time to Maximum Observed Plasma Concentration (Tmax) of Venetoclax [ Time Frame: Up to approximately 28 days after first dose of study drug ]
    Time to maximum plasma concentration (Tmax) of Venetoclax.
  • AUC of Venetoclax [ Time Frame: Up to approximately 28 days after first dose of study drug ]
    Area under the plasma concentration-time curve (AUC) of venetoclax.
  • Maximum Plasma Concentration (Cmax) of AMG 176 [ Time Frame: Up to approximately 16 days after first dose of study drug ]
    Maximum observed plasma concentration (Cmax) of AMG 176
  • Half-life (t1/2) of AMG 176 [ Time Frame: Approximately 16 days after first dose of study drug ]
    Terminal phase elimination half-life (t1/2)
  • AUC of AMG 176 [ Time Frame: Approximately 16 days after first dose of study drug ]
    Area Under the Plasma Concentration-time Curve (AUC) of AMG 176
  • Clearance (CL) of AMG 176 [ Time Frame: Approximately 16 days after first dose of study drug ]
    Clearance (CL) is defined the volume of plasma cleared of the drug per unit time.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Venetoclax and AMG 176 in Patients With Relapsed/Refractory Hematologic Malignancies
Official Title  ICMJE Phase 1b Study of Venetoclax and AMG 176 in Patients With Relapsed/Refractory Hematologic Malignancies
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Myeloid Leukemia
  • Non-Hodgkin's Lymphoma
  • Diffuse Large B-cell Lymphoma
Intervention  ICMJE
  • Drug: Venetoclax
    tablet, oral
    Other Name: ABT-199
  • Drug: AMG 176
    solution, intravenous
Study Arms  ICMJE Experimental: Venetoclax + AMG 176
Venetoclax and AMG 176 will be administered in combination. Different combinations of dose levels for venetoclax and AMG 176 will be explored.
Interventions:
  • Drug: Venetoclax
  • Drug: AMG 176
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: January 7, 2019)
86
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2, 2022
Estimated Primary Completion Date September 2, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adequate kidney, liver and hematology values as described in the protocol.
  • Diagnosis of relapsed or refractory (R/R) acute myeloid leukemia (AML) or R/R Non-Hodgkin's lymphoma (NHL)/diffuse large B-cell lymphoma (DLBCL) confirmed by the World Health Organization (WHO) criteria, as appropriate.
  • Meets the following disease activity criteria:
  • AML: must have received at least 1 prior therapy for AML and be ineligible for cytotoxic therapy and allogeneic stem cell transplant.
  • NHL/DLBCL: measurable disease with a bidimensional lesion measuring at least 1.5 cm; received at least 1 prior therapy for NHL with no curative treatment option as determined by the investigator and be ineligible for a stem cell transplant.

Exclusion Criteria:

  • History of clinically significant medical condition that, in the opinion of the investigator, would adversely affect participation in this study.
  • History of of any malignancy within the last 6 months except for those specified in this protocol and low-grade malignancies not requiring active treatment such as non-melanoma skin cancer, cervical intraepithelial neoplasia, or prostate cancer in situ.
  • Prior allogeneic stem cell transplant or autologous stem cell transplant within 100 days of study drug administration and no signs or symptoms of acute or chronic graft-versus-host disease.
  • Previous enrollment in a randomized trial including either venetoclax or AMG 176.
  • Known active or chronic pancreatitis; severe chronic obstructive pulmonary disease with hypoxemia; central nervous system manifestations of malignancy.
  • Active, uncontrolled infection.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Germany,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03797261
Other Study ID Numbers  ICMJE M16-785
2018-003314-41 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE
  • Genentech, Inc.
  • Amgen
Investigators  ICMJE
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP