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A Phase 1b/2, Multicenter, Open-label Study of ACP-196 in Subjects With Recurrent Glioblastoma Multiforme (GBM)

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: NCT02586857
Recruitment Status : Active, not recruiting
First Posted : October 27, 2015
Results First Posted : July 29, 2020
Last Update Posted : July 29, 2020
Sponsor:
Information provided by (Responsible Party):
Acerta Pharma BV

Brief Summary:
A Phase 1b/2, multicenter, open-label study designed to evaluate the efficacy and safety of ACP-196 in subjects with recurrent GBM who have progressed after 1 or 2 prior systemic treatment regimens.

Condition or disease Intervention/treatment Phase
Glioblastoma Multiforme Drug: ACP-196 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b/2, Multicenter, Open-label Study of ACP-196 in Subjects With Recurrent Glioblastoma Multiforme (GBM)
Actual Study Start Date : January 2016
Actual Primary Completion Date : March 29, 2018
Estimated Study Completion Date : June 5, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort 1
ACP-196 200mg administered PO BID
Drug: ACP-196
Experimental: Cohort 2
ACP-196 400mg administered PO QD
Drug: ACP-196



Primary Outcome Measures :
  1. Assessment of Tumor Status for Overall Response Rate With Use of RANO Criteria. [ Time Frame: On Cycle 3 Day 1, Cycle 4 Day 1 (4 weeks after Cycle 3 Day 1 scan to evaluate for response stability), then on Day 1 of every other cycle (every 8 weeks) thereafter (e.g., Cycle 6 Day 1, Cycle 8 Day 1) ]
    To evaluate the efficacy of acalabrutinib monotherapy in subjects with recurrent GBM based on overall response rate (ORR) per the Response Assessment in Neuro-oncology (RANO) criteria. Responses are either complete response (CR) or partial response (PR) by RANO.



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Histologically confirmed GBM at first or second recurrence after concurrent or adjuvant chemotherapy or radiotherapy (must have received temozolomide).
  • Radiographic demonstration of disease progression by MRI following prior therapy.
  • ECOG performance status ≤ 2.
  • Life expectancy ≥ 12 weeks.
  • Completion of all prior anticancer therapy before first ACP-196 dose.

Exclusion Criteria:

  • Three or more prior lines of systemic therapy for GBM.
  • Significant cardiovascular disease.
  • Evidence of bleeding diathesis or coagulopathy.
  • Requires urgent palliative intervention for primary disease.
  • History of stroke or clinically significant intracranial hemorrhage within 6 months before first dose of study drug.
  • Breastfeeding or pregnant.

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): NCT02586857


Locations
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United States, California
UCLA Neurology-Oncology Program
Los Angeles, California, United States, 90095
Stanford Cancer Center
Palo Alto, California, United States, 94305
United States, Massachusetts
Beth Israel Deaconness Medical Center
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Massachusetts General Hospital
Boston, Massachusetts, United States, 02215
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10021
United States, Washington
Northwest Cancer Specialists
Vancouver, Washington, United States, 98684
Sponsors and Collaborators
Acerta Pharma BV
Investigators
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Study Director: Acerta Clinical Trials 1-888-292-9613; acertamc@dlss.com
  Study Documents (Full-Text)

Documents provided by Acerta Pharma BV:
Study Protocol  [PDF] March 21, 2017
Statistical Analysis Plan  [PDF] April 7, 2018

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Responsible Party: Acerta Pharma BV
ClinicalTrials.gov Identifier: NCT02586857    
Other Study ID Numbers: ACE-ST-209
First Posted: October 27, 2015    Key Record Dates
Results First Posted: July 29, 2020
Last Update Posted: July 29, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Acerta Pharma BV:
Glioblastoma Multiforme
GBM
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue