Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study Evaluating the Safety and Pharmacokinetics of ABBV-744 in Subjects With Advanced Prostate Cancer (CRPC) and Relapsed/Refractory Acute Myeloid Leukemia (AML) Cancer

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03360006
Recruitment Status : Recruiting
First Posted : December 2, 2017
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
This is an open-label, Phase 1, dose-escalation (Segment 1) and expansion (Segment 2) study to determine the maximum tolerated dose (MTD) and the recommended phase two dose (RPTD), and to assess the safety, preliminary efficacy, and pharmacokinetic (PK) profile of ABBV-744 for participants with metastatic Castrate Resistant Prostate Cancer (CRPC) and relapsed/refractory Acute Myeloid Leukemia (AML).

Condition or disease Intervention/treatment Phase
Prostate Cancer Acute Myeloid Leukemia (AML) Drug: ABBV-744 Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABBV-744 in Subjects With Metastatic Castrate-Resistant Prostate Cancer (CRPC) and Relapsed/Refractory Acute Myeloid Leukemia (AML)
Actual Study Start Date : March 16, 2018
Estimated Primary Completion Date : September 27, 2019
Estimated Study Completion Date : March 31, 2022


Arm Intervention/treatment
Experimental: ABBV-744
ABBV-744 will be administered at escalating dose levels until the maximum tolerated dose is reached and a recommended Phase 2 dose is determined.
Drug: ABBV-744
Tablet, oral




Primary Outcome Measures :
  1. Dose-limiting toxicity (DLT) of ABBV-744 [ Time Frame: Up to 28 days after first dose of study drug ]
    DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications and occurring during the first 4 weeks after administration of the first dose and that meets additional criteria as described in the protocol.

  2. Time of ABBV-744 [ Time Frame: Up to 16 days after first dose of study drug in dose-escalation phase only ]
    Time to Cmax (Tmax) of ABBV-744

  3. Cmax of ABBV-744 [ Time Frame: Up to 16 days after first dose of study drug in dose-escalation phase only ]
    Maximum observed plasma concentration (Cmax) of ABBV-744

  4. Recommended Phase 2 Dose (RPTD) for ABBV-744 [ Time Frame: Up to 28 days after first dose of study drug ]
    RPTD will be determined from a review available safety, pharmacokinetic, and efficacy data during the dose escalation phase (Segment 1) of the study.

  5. AUCt of ABBV-744 [ Time Frame: Up to 16 days after first dose of study drug in dose-escalation phase only ]
    Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable concentration (AUCt) of ABBV-744

  6. Maximum Tolerated Dose (MTD) for ABBV-744 [ Time Frame: Up to 28 days after first dose of study drug ]
    The MTD is defined as the highest dose for which the estimated posterior mean DLT rate is <= 33% and excessive toxicity probability is limited to maximum of 25% during the first 28 days.


Secondary Outcome Measures :
  1. Duration of Response (DOR) for CRPC [ Time Frame: Up to 2 years ]
    Percentage of participants who achieve DOR where DOR is defined as the number of days from the day the response criteria are met to the date that disease progression is objectively documented.

  2. Objective Response Rate (ORR) for CRPC [ Time Frame: Up to 2 years ]
    Percentage of participants who achieve ORR where ORR is based on RECIST 1.1 criteria (partial response or complete response).

  3. ORR for AML [ Time Frame: Up to 2 years ]
    Percentage of participants who achieve where ORR for AML participants is based on the International Working Group (IWG) criteria (complete remission, complete remission with incomplete blood count recovery, partial remission, morphologic leukemia free state).

  4. Time to Prostate-specific Antigen (PSA) Progression for CRPC [ Time Frame: Up to 2 years ]
    Time to PSA Progression is defined as the number of days from the date the participant started study drug to time of confirmed PSA progression as defined by PCGW3.

  5. Progression-free survival (PFS) for Acute Myeloid Leukemia (AML) [ Time Frame: Up to 2 years ]
    Percentage of participants who achieve progression-free survival (PFS) where PFS is defined as the number of days from the date the participant started study drug to the date of the participants disease progression or death due to any cause, whichever occurs first.

  6. DOR for AML [ Time Frame: Up to 2 years ]
    DOR is defined as the number of days from the day the response criteria are met to the date that disease progression is objectively documented

  7. Overall PSA Response Rate for CRPC [ Time Frame: Up to 2 years ]
    Overall PSA response rate per PCWG3 criteria.

  8. Radiographic Progression Free Survival (rPFS) for CRPC [ Time Frame: Up to 2 years ]
    Percentage of participants who achieve rPFS where rPFS is describer per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and Prostate Cancer Working Group 3 (PCWG3) criteria.

  9. Time to Disease Progression (TTP) for CRPC [ Time Frame: Up to 2 years ]
    TTP is calculated as number of days from the date the participant started study drug to date of disease progression as confirmed per RECIST 1.1 and/or PCWG3 criteria.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant must have metastatic CRPC or AML not amenable to curative therapy, refractory to standard of care therapy or for which standard of care therapy does not exist. Participants with AML who are candidates for stem cell transplantation must have been offered this therapeutic option. Must meet additional criteria specific for each diagnosis, metastatic CRPC and relapsing/remitting AML, as described in the protocol.
  • Must consent to provide biomarker analyses as described in the protocol.
  • Must have an Eastern Cooperative Oncology Group (ECOG) Performance status of:
  • Dose Escalation (Segment 1): 0 - 1
  • Dose Expansion (Segment 2): 0 - 2
  • Dose Escalation: Must have a serum albumin during Screening of >= 3.2 g/dL.
  • Participant has adequate bone marrow, renal and hepatic function.

Exclusion Criteria:

  • Participant has untreated brain or meningeal metastases.
  • Participant has received anti-cancer traditional medicine or anti-cancer herbal remedies within 14 days prior to ABBV-744 dosing. Saw palmetto is considered anti-cancer herbal remedy. Participant with CRPC who has received anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, biologic or any investigational therapy within a period of 21 days prior to Study Day 1. Participant with AML has received anti-cancer therapy within a period of 14 days or 5 half-lives (whichever is longer; except for immunotherapy where a period of 21 days will be acceptable) prior to Study Day 1. Except for hydroxyurea which will be allowed during screening and treatment for controlling leukocytosis for AML subjects.
  • Participant has been previously treated with a Bromodomain and Extra-Terminal (BET) inhibitor
  • Participant has unresolved clinically significant toxicities from most recent prior anti-cancer therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE v 4.03) grade 2 or higher clinically significant toxicity (excluding alopecia).
  • Participant has received the following within 7 days prior to the first dose of study drug: corticosteroid therapy, CYP3A inhibitors, CYP3A inducers.
  • Participant consumed grapefruit or grapefruit products within 3 days prior to the first dose of study drug.
  • Participant had major surgery within 28 days prior to Study Day 1.
  • Participant is unable to swallow or absorb oral tablets.
  • Participant has known infection with hepatitis B or hepatitis C.
  • Participant has active peptic ulcer disease or other hemorrhagic esophagitis/gastritis, enteritis, colitis.
  • Participant has symptoms of gross hematuria or gross hemoptysis
  • Has electrocardiogram with a QT interval corrected for heart rate using Fridericia's formula (QTcF) > 470 msec or ECG with second degree type 2 or third degree atrioventricular block.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03360006


Contacts
Layout table for location contacts
Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

Locations
Layout table for location information
United States, California
UC Irvine /ID# 160789 Recruiting
Orange, California, United States, 92868
UC Davis Comp Cancer Ctr /ID# 202729 Recruiting
Sacramento, California, United States, 95817
United States, Illinois
Northwestern /ID# 171098 Recruiting
Chicago, Illinois, United States, 60611
University of Chicago /ID# 160702 Recruiting
Chicago, Illinois, United States, 60637-1443
United States, Ohio
Cleveland Clinic Main Campus /ID# 160756 Recruiting
Cleveland, Ohio, United States, 44195
United States, Texas
Univ TX, MD Anderson /ID# 160701 Recruiting
Houston, Texas, United States, 77030
United States, Washington
Swedish-Center for Blood Disor /ID# 166487 Recruiting
Seattle, Washington, United States, 98104
Sponsors and Collaborators
AbbVie
Investigators
Layout table for investigator information
Study Director: AbbVie Inc. AbbVie

Layout table for additonal information
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03360006     History of Changes
Other Study ID Numbers: M16-415
First Posted: December 2, 2017    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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

Keywords provided by AbbVie:
Castrate-Resistant Prostate Cancer (CRPC)
Metastatic Castrate-Resistant Prostate Cancer (CRPC)
Acute Myeloid Leukemia (AML)
Relapsing acute myeloid leukemia
Remitting acute myeloid leukemia
Dose-limiting toxicity
Recommended phase two dose
Pharmacokinetics

Additional relevant MeSH terms:
Layout table for MeSH terms
Leukemia
Prostatic Neoplasms
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases