Experimental drug ACP-196 takes on recurrent glioblastoma
NCT ID NCT02586857
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a drug called ACP-196 (acalabrutinib) in 24 adults with recurrent glioblastoma, an aggressive brain cancer that has returned after standard treatment. Participants take the drug by mouth once or twice daily. The main goal is to see if the drug can shrink tumors or stop them from growing, while also checking for side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ACP-196 (acalabrutinib)
- What this could lead to
- If successful, this could point toward a new treatment option for recurrent glioblastoma, a brain cancer with few effective therapies.
- What could go wrong
- This is an early-phase trial with only 24 participants, so results may not apply broadly. The drug may not shrink tumors or improve survival, and side effects are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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24 people
The number who actually took part.
- Started
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Jan 2016
- Expected to finish
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Apr 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 * 2 alopecia are an exception, and may qualify for the study. 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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Research Site
Los Angeles, California, 90095-1769, United States
-
Research Site
Palo Alto, California, 94304, United States
-
Research Site
Boston, Massachusetts, 02114, United States
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Research Site
Boston, Massachusetts, 02215, United States
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Research Site
Boston, Massachusetts, 2215, United States
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Research Site
New York, New York, 10021, United States
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Research Site
Vancouver, Washington, 98684, United States
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