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Bruton's Tyrosine Kinase (BTK) Inhibitor

ACP-196 for Glioblastoma

Phase 1 & 2
Waitlist Available
Research Sponsored by Acerta Pharma BV
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
Histologically confirmed GBM at first or second recurrence after concurrent or adjuvant chemotherapy or radiotherapy (must have received temozolomide)
Must not have
Subjects previously treated with bevacizumab (Avastin)
Requires treatment with a strong CYP3A4 inhibitor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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)
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug, ACP-196, for people with recurrent GBM.

Who is the study for?
This trial is for adults over 18 with recurrent Glioblastoma Multiforme (GBM) who've had prior therapy including temozolomide. Participants should have a life expectancy of at least 12 weeks, an ECOG status ≤2, and stable brain disease as seen on MRI. They must not have had more than two systemic therapies for GBM or certain other cancers within the last two years.
What is being tested?
The study tests ACP-196's effectiveness in treating GBM that has come back after treatment. It's open-label, meaning everyone knows they're getting ACP-196, and it involves multiple centers to gather diverse data.
What are the potential side effects?
While specific side effects for ACP-196 are not listed here, common ones may include fatigue, headache, nausea, and potential risks associated with immune system changes since it targets cancer cell growth pathways.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
My GBM has returned after treatment with chemotherapy or radiotherapy, including temozolomide.
Select...
My MRI shows my condition has worsened after treatment.
Select...
My MRI shows a tumor larger than 1 cm, taken within the last 21 days.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been treated with Avastin before.
Select...
I need treatment with a strong medication that affects liver enzymes.
Select...
I have had 3 or more treatments for brain cancer.
Select...
I have a serious heart condition.
Select...
I need immediate treatment to relieve symptoms of my main illness.
Select...
I do not have major issues with my stomach or intestines that affect how I digest food.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Assessment of Tumor Status for Overall Response Rate With Use of RANO Criteria.

Side effects data

From 2017 Phase 2 trial • 77 Patients • NCT02362048
34%
Anaemia
31%
Headache
31%
Fatigue
31%
Decreased Appetite
29%
Abdominal Pain
26%
Oedema Peripheral
23%
Nausea
23%
Constipation
23%
Back Pain
17%
Diarrhoea
17%
Dehydration
17%
Vomiting
14%
Dyspnoea
14%
Abdominal Distension
14%
Pyrexia
14%
Myalgia
14%
Blood Creatinine Increased
14%
Platelet Count Decreased
11%
Ascites
11%
Dizziness
11%
Hypotension
11%
Pain in Extremity
11%
Weight Decreased
9%
Dyspepsia
9%
Hypoalbuminaemia
9%
Hyponatraemia
9%
Vaginal Haemorrhage
9%
Asthena
9%
Hypokalaemia
9%
Arthralgia
9%
Musculoskeletal Chest Pain
9%
Alanine Aminotransferase Increased
9%
Anxiety
6%
Gastrooesophageal Reflux Disease
6%
Upper Respiratory Tract Infection
6%
Contusion
6%
Aspartate Aminotransferase Increased
6%
Muscular Weakness
6%
Urinary Tract Infection
6%
Insomnia
6%
Sinus Tachycardia
6%
Rash
6%
Pleural Effusion
6%
Dry Skin
6%
Cholangitis
6%
Pneumonia
6%
Chills
6%
Fall
6%
Blood Alkaline Phosphatase Increased
6%
Atelectasis
6%
Acute Kidney Injury
6%
Haematuria
6%
Stomatitis
3%
Klebsiella Sepsis
3%
Somnolence
3%
Abdominal Pain Upper
3%
Tumour Associated Fever
3%
Blood Bilirubin Increased
3%
Pruritus
3%
Failure to Thrive
3%
Hepatic Infection
3%
Hyperglycaemia
3%
Night Sweats
3%
Oesophagitis Ulcerative
3%
Duodenal Ulcer
3%
Hepatic Function Abnormal
3%
Sepsis
3%
Abdominal Infection
3%
Bacteraemia
3%
Clostridium Difficile Colitis
3%
Escherichia Sepsis
3%
Hypovolaemia
3%
Respiratory Failure
3%
Orthostatic Hypotension
3%
Thrombocytopenia
3%
Pain
3%
Influenza like Illness
3%
Hyperkalaemia
3%
Depression
3%
Cough
3%
Musculoskeletal Pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm 1 - Acalabrutinib Monotherapy
Arm 2- Acalabrutinib+Pembrolizumab

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort 2Experimental Treatment1 Intervention
ACP-196 400mg administered orally (PO) once per day (QD).
Group II: Cohort 1Experimental Treatment1 Intervention
ACP-196 200 mg administered orally (PO) twice per day (BID)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ACP-196
2016
Completed Phase 2
~310

Find a Location

Who is running the clinical trial?

Acerta Pharma BVLead Sponsor
45 Previous Clinical Trials
5,901 Total Patients Enrolled
Acerta Clinical TrialsStudy Director1-888-292-9613; acertamc@dlss.com
17 Previous Clinical Trials
2,402 Total Patients Enrolled

Media Library

ACP-196 (Bruton's Tyrosine Kinase (BTK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02586857 — Phase 1 & 2
Glioblastoma Research Study Groups: Cohort 1, Cohort 2
Glioblastoma Clinical Trial 2023: ACP-196 Highlights & Side Effects. Trial Name: NCT02586857 — Phase 1 & 2
ACP-196 (Bruton's Tyrosine Kinase (BTK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02586857 — Phase 1 & 2
~2 spots leftby Nov 2025
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