Glioblastoma MultiformePhase 1/2NCT02586857
A Phase 1b/2, Multicenter, Open-label Study of ACP-196 in Subjects With Recurrent Glioblastoma Multiforme (GBM)
A Phase 1/2 study testing ACP-196 in people with Glioblastoma Multiforme, run by Acerta Pharma BV at 7 sites in United States.
Trial summary
A Phase 1b/2, Multicenter, Open-Label Study of ACP-196 in Subjects with Recurrent Glioblastoma Multiforme (GBM) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- ACP-196
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 7 sitesUnited States
- Study dates
- 25 Jan 2016to 1 Apr 2026
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Research Site
Boston, Massachusetts, 02114
Research Site
Boston, Massachusetts, 02215
Research Site
Boston, Massachusetts, 2215
Research Site
Los Angeles, California, 90095-1769
Research Site
New York, New York, 10021
Research Site
Palo Alto, California, 94304
Research Site
Vancouver, Washington, 98684
About this study
A Phase 1b/2, Multicenter, Open-Label Study of ACP-196 in Subjects with Recurrent Glioblastoma Multiforme (GBM)
Read the 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.
- Conditions
- Glioblastoma Multiforme
- Being tested
- ACP-196
- Keywords
- Glioblastoma Multiforme, GBM, Btk,, CLL, Chronic Lymphocytic Leukemia, NK, Natural Killer (Cells), ORR, Overall Response Rate, OS, Overall Survival, RANO, Response Assessment in Neuro-oncology (Criteria), RCI, Reliale Change Index (methodology)
- Medical subject headings
- Glioblastoma, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACP-196Drug
Also called Acalabrutinib.
Cohort 1: ACP-196 200 mg (PO) twice per day (BID) Cohort 2: ACP-196 400 mg (PO) once per day (QD).
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | ACP-196 200 mg administered orally (PO) twice per day (BID) Receives: Drug: ACP-196 |
| Cohort 2 | Experimental | ACP-196 400mg administered orally (PO) once per day (QD). Receives: Drug: ACP-196 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Tumor Status for Overall Response Rate With Use of RANO Criteria.
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study start25 Jan 2016
- Primary completion26 Jun 2020
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acerta Pharma BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Acerta Clinical Trials, Study director, 1-888-292-9613; acertamc@dlss.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02586857
- Sponsor's protocol ID
- ACE-ST-209
- Status last verified
- Mar 2026
- First submitted
- 17 Oct 2015
- Last updated
- 25 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2, Multicenter, Open-label Study of ACP-196 in Subjects With Recurrent Glioblastoma Multiforme (GBM)
- ClinicalTrials.gov ID
- NCT02586857
- Acronym / sponsor ID
- ACE-ST-209
- Conditions
- Glioblastoma Multiforme
- Keywords
- Glioblastoma Multiforme, GBM, Btk,, CLL, Chronic Lymphocytic Leukemia, NK, Natural Killer (Cells), ORR
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Acerta Pharma BVIndustry (pharma, biotech, devices)
- Study start
- 25 Jan 2016 (actual)
- Primary completion
- 26 Jun 2020 (actual)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 27 Oct 2015 (estimated)
- Results
- Posted 29 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: ACP-196ACP-196 200 mg administered orally (PO) twice per day (BID) |
| Cohort 2 | Experimental | Drug: ACP-196ACP-196 400mg administered orally (PO) once per day (QD). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACP-196Also: Acalabrutinib.Cohort 1: ACP-196 200 mg (PO) twice per day (BID) Cohort 2: ACP-196 400 mg (PO) once per day (QD). | Drug | Cohort 1, Cohort 2 |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Redacted CSPLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Acerta Clinical Trials study director
1-888-292-9613; acertamc@dlss.com
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ACP-196 in people with Glioblastoma Multiforme, run by Acerta Pharma BV at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.