Trial Outcomes & Findings for A Phase 1b/2, Multicenter, Open-label Study of ACP-196 in Subjects With Recurrent Glioblastoma Multiforme (GBM) (NCT NCT02586857)
NCT ID: NCT02586857
Last Updated: 2026-01-12
Results Overview
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.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1/PHASE2
Target enrollment
24 participants
Primary outcome timeframe
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)
Results posted on
2026-01-12
Participant Flow
Participant milestones
| Measure |
Cohort 1 - Acalabrutinib
Acalabrutinib 200mg PO BID.
|
Cohort 2 - Acalabrutinib
Acalabrutinib 400mg PO QD.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
9
|
|
Overall Study
Enrolled
|
15
|
9
|
|
Overall Study
Received Study Medication
|
15
|
9
|
|
Overall Study
Discontinued Study
|
14
|
9
|
|
Overall Study
COMPLETED
|
14
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase 1b/2, Multicenter, Open-label Study of ACP-196 in Subjects With Recurrent Glioblastoma Multiforme (GBM)
Baseline characteristics by cohort
| Measure |
Cohort 1
n=15 Participants
Acalabrutinib 200mg administered orally (PO) twice daily (BID).
|
Cohort 2
n=9 Participants
Acalabrutinib 400mg PO (QD).
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.7 Year
STANDARD_DEVIATION 6.74 • n=210 Participants
|
45.7 Year
STANDARD_DEVIATION 13.84 • n=19 Participants
|
53.8 Year
STANDARD_DEVIATION 11.64 • n=8 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=210 Participants
|
4 Participants
n=19 Participants
|
11 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=210 Participants
|
5 Participants
n=19 Participants
|
13 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=210 Participants
|
1 Participants
n=19 Participants
|
1 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=210 Participants
|
7 Participants
n=19 Participants
|
22 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=210 Participants
|
1 Participants
n=19 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=210 Participants
|
8 Participants
n=19 Participants
|
21 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=210 Participants
|
1 Participants
n=19 Participants
|
2 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=210 Participants
|
9 Participants
n=19 Participants
|
24 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Cohort 1
n=15 Participants
Acalabrutinib 200mg by PO BID.
|
Cohort 2
n=9 Participants
Acalabrutinib 400mg by PO QD.
|
|---|---|---|
|
Assessment of Tumor Status for Overall Response Rate With Use of RANO Criteria.
|
1 Participants
|
1 Participants
|
Adverse Events
Cohort 1
Serious events: 6 serious events
Other events: 15 other events
Deaths: 12 deaths
Cohort 2 - Acalabrutinib
Serious events: 4 serious events
Other events: 9 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Cohort 1
n=15 participants at risk
Acalabrutinib 200mg administered orally (PO) twice daily (BID).
|
Cohort 2 - Acalabrutinib
n=9 participants at risk
Acalabrutinib 400mg PO (QD)
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
13.3%
2/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
11.1%
1/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Gastrointestinal disorders
Abdominal Pain
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Gastrointestinal disorders
Large Intestine Perforation
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Infections and infestations
Influenze
|
0.00%
0/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
11.1%
1/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Infections and infestations
Streptococcal
|
0.00%
0/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
11.1%
1/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Infections and infestations
Abdominal Infection
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Investigations
Alanine Aminotransferase Increased
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Investigations
Aspartate Aminotransferase Increased
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
11.1%
1/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Nervous system disorders
Brain Oedema
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Nervous system disorders
Haemorrhage Intracranial
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Nervous system disorders
Headache
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Nervous system disorders
Seizure
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Nervous system disorders
Syncope
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Psychiatric disorders
Confusional State
|
0.00%
0/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
11.1%
1/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Skin and subcutaneous tissue disorders
Rash Macular
|
0.00%
0/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
11.1%
1/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
Other adverse events
| Measure |
Cohort 1
n=15 participants at risk
Acalabrutinib 200mg administered orally (PO) twice daily (BID).
|
Cohort 2 - Acalabrutinib
n=9 participants at risk
Acalabrutinib 400mg PO (QD)
|
|---|---|---|
|
General disorders
Catheter Site Pain
|
0.00%
0/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
11.1%
1/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
General disorders
Gait Disturbance
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
11.1%
1/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
General disorders
Mucosal Inflammation
|
0.00%
0/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
11.1%
1/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
General disorders
Oedema Peripheral
|
20.0%
3/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
11.1%
1/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
General disorders
Chest Discomfort
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
General disorders
Chest Pain
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
General disorders
Feeling Cold
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
General disorders
Non-Cardiac Chest Pain
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
11.1%
1/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
11.1%
1/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Nervous system disorders
Hemiparesis
|
26.7%
4/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Nervous system disorders
Parosmia
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Nervous system disorders
Syncope
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Psychiatric disorders
Anxiety
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
11.1%
1/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Nervous system disorders
Cognitive Disoder
|
0.00%
0/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
11.1%
1/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Nervous system disorders
Disturbance in Attention
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Renal and urinary disorders
Haematuria
|
13.3%
2/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Renal and urinary disorders
Micturition Urgency
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Renal and urinary disorders
Nephrolithiasis
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Renal and urinary disorders
Pollakiuria
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Renal and urinary disorders
Urinary Incontinence
|
13.3%
2/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Respiratory, thoracic and mediastinal disorders
Apiration
|
0.00%
0/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
11.1%
1/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
11.1%
1/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Psychiatric disorders
Depression
|
0.00%
0/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
11.1%
1/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Psychiatric disorders
Confusional State
|
13.3%
2/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Infections and infestations
Oesophageal Candidiasis
|
0.00%
0/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
11.1%
1/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
11.1%
1/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Infections and infestations
Tinea Pedis
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Infections and infestations
Urinary Tract Infection
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Injury, poisoning and procedural complications
Fall
|
26.7%
4/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
22.2%
2/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Injury, poisoning and procedural complications
Contusion
|
13.3%
2/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
11.1%
1/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
13.3%
2/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
11.1%
1/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Gastrointestinal disorders
Haemorrhoidal Haemorrhage
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
General disorders
Fatigue
|
40.0%
6/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
33.3%
3/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Cardiac disorders
Sinus Bradycardia
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
22.2%
2/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Ear and labyrinth disorders
Cerumen Impaction
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Ear and labyrinth disorders
Ear Pain
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Ear and labyrinth disorders
Hypoacusis
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Ear and labyrinth disorders
Vertigo Positional
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Eye disorders
Vision Blurred
|
13.3%
2/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Gastrointestinal disorders
Nausea
|
20.0%
3/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
33.3%
3/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
5/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
33.3%
3/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Gastrointestinal disorders
Diarrhoea
|
26.7%
4/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
22.2%
2/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
22.2%
2/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Gastrointestinal disorders
Abdominal Distension
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
11.1%
1/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Gastrointestinal disorders
Constipation
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
11.1%
1/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Gastrointestinal disorders
Abdominal Pain
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Gastrointestinal disorders
Dyspepsia
|
13.3%
2/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Injury, poisoning and procedural complications
Procedural Complication
|
0.00%
0/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
11.1%
1/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Investigations
CD4 Lymphocytes Decreased
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
22.2%
2/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Investigations
Platelet Count Decreased
|
0.00%
0/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
11.1%
1/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Investigations
Vitamin D Decreased
|
0.00%
0/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
11.1%
1/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Investigations
Weight Decreased
|
0.00%
0/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
11.1%
1/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Investigations
White Blood Cell Count Decreased
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
11.1%
1/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Investigations
Lymphocyte Count Decreased
|
20.0%
3/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
11.1%
1/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Investigations
Alanine Aminotransferase Increased
|
13.3%
2/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Investigations
Aspartate Aminotransferase Increased
|
13.3%
2/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Investigations
Neutrophil Count Decreased
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Metabolism and nutrition disorders
Dehydration
|
20.0%
3/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
22.2%
2/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
11.1%
1/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
11.1%
1/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
11.1%
1/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Metabolism and nutrition disorders
Increased Appetite
|
0.00%
0/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
11.1%
1/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
13.3%
2/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
11.1%
1/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
11.1%
1/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
11.1%
1/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
13.3%
2/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Nervous system disorders
Headache
|
46.7%
7/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
55.6%
5/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Nervous system disorders
Aphasia
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
22.2%
2/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Nervous system disorders
Dizziness
|
20.0%
3/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
22.2%
2/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Nervous system disorders
Depressed Level of Consciousness
|
0.00%
0/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
11.1%
1/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Nervous system disorders
Memory Impairment
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
11.1%
1/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Nervous system disorders
Seizure
|
0.00%
0/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
11.1%
1/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Nervous system disorders
Akathisia
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Nervous system disorders
Brain Oedema
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Nervous system disorders
Cognitive Disorder
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Nervous system disorders
Dysarthria
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
0.00%
0/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
11.1%
1/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
13.3%
2/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
11.1%
1/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
11.1%
1/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Skin and subcutaneous tissue disorders
Rash Macular
|
0.00%
0/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
11.1%
1/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Skin and subcutaneous tissue disorders
Acne
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Aceneiform
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Vascular disorders
Hypertension
|
0.00%
0/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
11.1%
1/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Vascular disorders
Hot Flush
|
6.7%
1/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
0.00%
0/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
|
Psychiatric disorders
Insomnia
|
13.3%
2/15 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
22.2%
2/9 • Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
|
Additional Information
Priti Patel, MD, Executive Director - Head of Clinical Development
Acerta Pharma, LLC
Phone: 1-888-292-9613
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place