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Trial record 1 of 2 for:    Acerta 208
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A Study of ACP-196 (Acalabrutinib) in Subjects With Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02717611
First Posted: March 24, 2016
Last Update Posted: August 14, 2017
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.
Information provided by (Responsible Party):
Acerta Pharma BV
  Purpose
A Phase 2 Study to evaluate the Efficacy and Safety of ACP-196 (acalabrutinib) in Subjects with Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy

Condition Intervention Phase
Chronic Lymphocytic Leukemia Drug: ACP-196 (acalabrutinib) Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of the Efficacy and Safety of ACP-196 in Subjects With Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy

Resource links provided by NLM:


Further study details as provided by Acerta Pharma BV:

Primary Outcome Measures:
  • The overall response rate (ORR) of ACP-196 (acalabrutinib) in subjects with relapsed/refractory CLL who are intolerant of ibrutinib therapy [ Time Frame: 36 cycles (each cycle is 28 days) up to 36 months ]

Enrollment: 60
Study Start Date: January 2016
Estimated Study Completion Date: February 2020
Estimated Primary Completion Date: February 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ACP-196 (acalabrutinib) Drug: ACP-196 (acalabrutinib)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men and women ≥ 18 years of age.
  2. Prior diagnosis of CLL
  3. Must have received ≥ 1 prior therapy for CLL
  4. Intolerant of ibrutinib
  5. Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty.
  6. ECOG performance status of ≤ 2.

Exclusion Criteria:

  1. Ongoing AE attributed to ibrutinib therapy
  2. Treatment with systemic anticancer therapy for CLL is prohibited between discontinuation of ibrutinib and enrollment on this trial.
  3. Prior exposure to a BCL-2 inhibitor (eg, venetoclax/ABT-199)
  4. Prior malignancy (other than CLL), except for adequately treated basal cell or squamous cell skin cancer, in situ cancer, or other cancer from which the subject has been disease free for ≥ 2 years.
  5. Significant cardiovascular disease such as uncontrolled or symptomatic untreated arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or QTc > 480 msec at screening. Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study.
  Contacts and Locations
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): NCT02717611


  Show 49 Study Locations
Sponsors and Collaborators
Acerta Pharma BV
Investigators
Study Director: Priti Patel, MD Acerta Pharma
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Acerta Pharma BV
ClinicalTrials.gov Identifier: NCT02717611     History of Changes
Other Study ID Numbers: ACE-CL-208
First Submitted: March 11, 2016
First Posted: March 24, 2016
Last Update Posted: August 14, 2017
Last Verified: November 2016

Keywords provided by Acerta Pharma BV:
Chronic Lymphocytic Leukemia
Ibrutinib Intolerant

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell