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

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ClinicalTrials.gov Identifier: NCT02586857
Recruitment Status : Active, not recruiting
First Posted : October 27, 2015
Last Update Posted : June 29, 2018
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
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)
Study Start Date : January 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. The primary safety outcome measure includes type, frequency, severity, timing of onset, duration, and relationship to study drug of any TEAEs or abnormalities of laboratory tests, SAEs, DLTs, or AEs leading to discontinuation of study treatment. [ Time Frame: 13 cycles (each cycle is 28 days) ]
  2. The primary efficacy outcome measure is overall response rate (ORR) per the Response Assessment in Neuro-oncology (RANO) criteria assessed by investigator. [ Time Frame: 13 cycles (each cycle is 28 days) ]


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
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

Responsible Party: Acerta Pharma BV
ClinicalTrials.gov Identifier: NCT02586857     History of Changes
Other Study ID Numbers: ACE-ST-209
First Posted: October 27, 2015    Key Record Dates
Last Update Posted: June 29, 2018
Last Verified: February 2018

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:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue