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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)
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
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)
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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assessment of Tumor Status for Overall Response Rate With Use of RANO Criteria.
Side effects data
From 2017 Phase 2 trial • 77 Patients • NCT0236204855%
Abdominal Pain
47%
Decreased Appetite
42%
Fatigue
39%
Vomiting
37%
Anaemia
37%
Nausea
34%
Constipation
29%
Headache
24%
Hyponatraemia
24%
Dyspnoea
24%
Abdominal Distension
24%
Pyrexia
24%
Ascites
18%
Dehydration
18%
Pruritus
16%
Hypoalbuminaemia
16%
Pleural Effusion
16%
Hypokalaemia
16%
Back Pain
16%
Blood Alkaline Phosphatase Increased
16%
Insomnia
13%
Urinary Tract Infection
13%
Oedema Peripheral
13%
Hypotension
13%
Alanine Aminotransferase Increased
13%
Cough
11%
Hyperglycaemia
11%
Thrombocytopenia
11%
Dry Skin
11%
Blood Bilirubin Increased
11%
Aspartate Aminotransferase Increased
11%
Petechiae
11%
Chills
11%
Hypocalcaemia
11%
Myalgia
11%
Blood Creatinine Increased
8%
Abdominal Pain Upper
8%
Dyspepsia
8%
Diarrhoea
8%
Pneumonia
8%
Rash
8%
Hyperkalaemia
8%
Lymphocyte Count Decreased
8%
Anxiety
8%
Acute Kidney Injury
8%
Urinary Retention
8%
Musculoskeletal Pain
5%
Mucosal Inflammation
5%
Tachycardia
5%
Pulmonary Embolism
5%
Gastrooesophageal Reflux Disease
5%
Peripheral Sensory Neuropathy
5%
Contusion
5%
Atrial Fibrillation
5%
Erythema
5%
Pelvic Pain
5%
Night Sweats
5%
Rash Maculo-Papular
5%
Cholangitis
5%
Asthena
5%
Pain
5%
Influenza like Illness
5%
Chest Discomfort
5%
Chest Pain
5%
Arthralgia
5%
Fall
5%
Productive Cough
5%
Oropharyngeal Pain
5%
Depression
5%
Candida Infection
3%
Subdural Haemorrhage
3%
Cerebellar Infarction
3%
Gastrointestinal Obstruction
3%
Musculoskeletal Chest Pain
3%
Hip Fracture
3%
Sinus Tachycardia
3%
Spinal Cord Compression
3%
Septic Shock
3%
Dizziness
3%
Abdomincal Distension
3%
Upper Gastrointestinal Haemorrage
3%
Asthenia
3%
Autoimmune Hepatitis
3%
Bile Duct Obstruction
3%
Cholecystitis
3%
Portal Vien Thrombosis
3%
Sepsis
3%
Troponin T Increased
3%
Haematuria
3%
Malignant Ascites
3%
Lower Gastrointestinal Haemorrhage
3%
Malignant Bowel Obstruction
3%
Intestinal Obstruction
3%
Escherichia Urinary Tract Infection
3%
Platelet Count Decreased
3%
Atelectasis
3%
Stomatitis
3%
Weight Decreased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm 2- Acalabrutinib+Pembrolizumab
Arm 1 - Acalabrutinib Monotherapy
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.My steroid dose has been stable or decreasing for at least 5 days before my baseline MRI.I can take care of myself but might not be able to do heavy physical work.I have finished all my previous cancer treatments before starting ACP-196.I have recovered from side effects of previous cancer treatments, except for mild neuropathy or hair loss.I have been treated with Avastin before.I need treatment with a strong medication that affects liver enzymes.I have had cancer before, but I've been cancer-free for over 2 years, except for certain skin cancers or in situ cervical cancer.My GBM has returned after treatment with chemotherapy or radiotherapy, including temozolomide.My MRI shows my condition has worsened after treatment.I have had 3 or more treatments for brain cancer.I have a serious heart condition.I need immediate treatment to relieve symptoms of my main illness.I do not have major issues with my stomach or intestines that affect how I digest food.My MRI shows a tumor larger than 1 cm, taken within the last 21 days.I have been on a stable dose of my required medication for at least 3 weeks.I have not had a stroke or significant brain bleed in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1
- Group 2: Cohort 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
For what common conditions is ACP-196 administered?
"ACP-196 has been tested for its efficacy in treating mantle cell lymphoma (MCL), small lymphocytic lymphoma, and chronic lypmphocytic leukemia (CLL)."
Answered by AI
Is this a pioneering clinical trial?
"Presently, there are 75 trials ongoing for ACP-196 spanning 507 cities and 47 nations. The first trial involving 306 participants was initiated in 2014 by Acerta Pharma BV as a means to gain approval across Phase 1 & 2 stages; since then 24 studies have been finalized."
Answered by AI
What is the geographic spread of this experiment?
"At this time, there are 5 clinical trial sites that have been approved to offer the medication. These locations include Boston, Los Angeles and Palo Alto among others. It is encouraged for potential participants to choose a location close by in order to reduce travel requirements during enrollment."
Answered by AI
What is the target recruitment size for this medical study?
"This clinical trial is not presently enrolling candidates. It was initially posted on January 25th, 2016 and last updated November 4th, 2022. If you're exploring other potential studies, there are currently 441 trials actively accepting patients with glioblastoma multiforme (gbm) and 75 for ACP-196 looking for participants."
Answered by AI
Are there opportunities to join this experiment presently?
"At this time, no further participants are being admitted to the trial. It was initially posted on 1/25/2016 and last modified 11/4/2022. If you're seeking other studies, there are currently 441 clinical trials for glioblastoma multiforme (GBM) actively enrolling patients and 75 trials involving ACP-196 with open recruitment statuses."
Answered by AI
What other experiments have been performed on the effects of ACP-196?
"Presently, there are 75 trials being conducted to explore ACP-196. Of those studies, 11 have advanced to Phase 3. This research is mainly centered in Houston, Texas but also has a presence at 2,427 other sites throughout the US."
Answered by AI
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