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ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

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

NCT02586857•Acerta Pharma BV

Summary

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

Detailed Description

A Phase 1b/2, multicenter, open-label study was designed to evaluate the efficacy and safety of acalabrutinib in subjects with recurrent glioblastoma multiforme (GBM) who had progressed after one or two prior systemic treatment regimens.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Men and women ≥18 years of age
•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.
•Measurable disease (bidimensional) as defined by the RANO criteria, with a minimum measurement of 1 cm in longest diameter on MRI performed within 21 days of first dose of acalabrutinib; MRI must have been obtained ≥4 weeks after any salvage surgery after first or second relapse.
•Stable or decreasing dose of corticosteroids ≥5 days before baseline MRI (at study entry).
•On a stable dose of any required therapy (such as anticonvulsant medication for subjects to be enrolled into the Phase 1b portion), for ≥3 weeks before the first dose of acalabrutinib.
•Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
•Life expectancy ≥ 12 weeks.
•Completion of all prior anticancer therapy before first ACP-196 dose.
•Need to have recovered (i.e., Grade ≤1 or baseline) from AEs associated with prior cancer therapy. Note: Subjects with Grade ≤2 neuropathy or Grade
+1 more criteria

Exclusion Criteria

•Three or more prior lines of systemic therapy for GBM.
•Prior malignancy (other than GBM), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥2 years. Any cases of prior malignancy allowed on study are to be approved by the study medical monitor.
•Significant cardiovascular disease.
•Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass.
•Evidence of bleeding diathesis or coagulopathy.
•Requires urgent palliative intervention for primary disease
•Requires treatment with a strong CYP3A4 inhibitor..
•History of stroke or clinically significant intracranial hemorrhage within 6 months before first dose of study drug.
•Breastfeeding or pregnant.
•Subjects previously treated with bevacizumab (Avastin)

Locations (7)

Research Site

Los Angeles, California, United States

Research Site

Palo Alto, California, United States

Research Site

Boston, Massachusetts, United States

Research Site

Boston, Massachusetts, United States

Research Site

Boston, Massachusetts, United States

Research Site

New York, New York, United States

Research Site

Vancouver, Washington, United States

Key Dates

Start Date

January 25, 2016

Primary Completion Date

June 26, 2020

Completion Date

April 1, 2026

Last Updated

January 12, 2026

Enrollment

ACTUAL participants

Conditions

Glioblastoma Multiforme

Interventions

ACP-196

DRUG

Targeted Pediatric High-Grade Glioma Therapy

NCT05839379

High Grade GliomaDiffuse Intrinsic Pontine Glioma+7 more

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RECRUITING

Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme

NCT00083512

Glioblastoma Multiforme

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Targeted Pediatric High-Grade Glioma Therapy

Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme

Study of TLX101-Tx Plus Standard of Care (SoC) Versus SoC Alone for the Treatment of Patients With Recurrent Glioblastoma

Improving Understanding of Glioblastoma Through Preservation of Biologically Active Brain Tissue

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Carmustine Wafer in Combination With Retifanlimab and Radiation With/Without Temozolomide in Subjects With Glioblastoma