A Study of ACP-196 (Acalabrutinib) in Subjects With Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy

Sponsor
Acerta Pharma BV (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02717611
Collaborator
(none)
60
Enrollment
23
Locations
1
Arm
117.8
Anticipated Duration (Months)
2.6
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or DiseaseIntervention/TreatmentPhase
  • Drug: ACP-196 (acalabrutinib)
Phase 2

Detailed Description

A Multicenter, Open-Label, Phase 2 study evaluating the efficacy and safety of Acalabrutinib in subjects with relapsed/refractory CLL (N=60) who are intolerant of ibrutinib therapy.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
N/A
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
Actual Study Start Date :
Mar 8, 2016
Actual Primary Completion Date :
Oct 16, 2020
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

ArmIntervention/Treatment
Experimental: ACP-196 (acalabrutinib)

ACP-196 (acalabrutinib) 100 mg to be administered orally (PO) twice a day BID

Drug: ACP-196 (acalabrutinib)
ACP-196 100 mg to be administered orally (PO) twice a day BID.
Other Names:
  • Acalabrutinib
  • Outcome Measures

    Primary Outcome Measures

    1. The overall response rate (ORR) of ACP-196 (acalabrutinib) [36 cycles (each cycle is 28 days) up to 36 months]

      The overall response rate (ORR) of ACP-196 (acalabrutinib) in subjects with relapsed / refractory CLL who are intolerant of ibrutinib therapy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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. Documented disease progression after stopping ibrutinib therapy as defined by the IWCLL 2008 criteria

    6. Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty.

    7. 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.

    1. Malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach, extensive small bowel resection that is likely to affect absorption, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass.

    2. Evidence of active Richter's transformation or any evidence of disease progression on ibrutinib therapy or any BTK inhibitor.

    3. CNS involvement by CLL or related Richter's transformation.

    4. Known history of human immunodeficiency virus (HIV), serologic status reflecting active hepatitis B or C infection, or any uncontrolled active systemic infection.

    5. Uncontrolled autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura (ITP)

    6. History of stroke or intracranial hemorrhage within 2 months before the first dose of study drug.

    7. History of bleeding diathesis.

    8. Presence of a gastrointestinal ulcer diagnosed by endoscopy within 3 months before screening.

    9. Major surgical procedure within 28 days of first dose of study drug.

    10. Requires treatment with a strong CYP3A inhibitor

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Research SiteTucsonArizonaUnited States85704
    2Research SiteConcordCaliforniaUnited States94520
    3Research SiteLa JollaCaliforniaUnited States92093
    4Research SitePalo AltoCaliforniaUnited States94304
    5Research SiteWashingtonDistrict of ColumbiaUnited States20007
    6Research SiteChicagoIllinoisUnited States60611
    7Research SiteLake SuccessNew YorkUnited States11042
    8Research SiteNew YorkNew YorkUnited States10021
    9Research SiteColumbusOhioUnited States43210
    10Research SiteNashvilleTennesseeUnited States37203
    11Research SiteHoustonTexasUnited States77030
    12Research SiteShermanTexasUnited StatesUSA
    13Research SiteSeattleWashingtonUnited States98108
    14Research SiteSeattleWashingtonUnited States98122
    15Research SiteSpokaneWashingtonUnited States99208
    16Research SiteMilwaukeeWisconsinUnited States53226
    17Research SiteBruggeBelgium8000
    18Research SiteBordeauxFrance33076, FR
    19Research SiteHaifaIsrael31000
    20Research SiteMadridSpain28006
    21Research SiteBournemouthUnited KingdomBH7 7DW
    22Research SiteLeedsUnited KingdomLS9 7TF
    23Research SiteManchesterUnited KingdomM20 4BX

    Sponsors and Collaborators

    • Acerta Pharma BV

    Investigators

    • Study Director: Acerta Clinical Trials, 1-888-292-9613; acertamc@dlss.com

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Acerta Pharma BV
    ClinicalTrials.gov Identifier:
    NCT02717611
    Other Study ID Numbers:
    • ACE-CL-208
    First Posted:
    Mar 24, 2016
    Last Update Posted:
    Sep 5, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Acerta Pharma BV
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 5, 2021