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Trial record 5 of 32 for:    Acerta Pharma | ( Map: United States )

An Open-label, Phase 2 Study of ACP-196 (Acalabrutinib) in Subjects With Mantle Cell Lymphoma

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ClinicalTrials.gov Identifier: NCT02213926
Recruitment Status : Active, not recruiting
First Posted : August 12, 2014
Results First Posted : October 19, 2018
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Acerta Pharma BV

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Mantle Cell Lymphoma (MCL)
Intervention Drug: ACP-196 (acalabrutinib)
Enrollment 124
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ACP-196 (Acalabrutinib)
Hide Arm/Group Description ACP-196 (acalabrutinib) 100 mg BID
Period Title: Overall Study
Started 124
Completed 54
Not Completed 70
Arm/Group Title ACP-196 (Acalabrutinib) Regimen 1
Hide Arm/Group Description The study has 1 regimen. All patients receiving ACP-196 (acalabrutinib) 100mg BID.
Overall Number of Baseline Participants 124
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 124 participants
68
(42 to 90)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 124 participants
Female
25
  20.2%
Male
99
  79.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 124 participants
Hispanic or Latino
4
   3.2%
Not Hispanic or Latino
90
  72.6%
Unknown or Not Reported
30
  24.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 124 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
   2.4%
White
92
  74.2%
More than one race
0
   0.0%
Unknown or Not Reported
29
  23.4%
Number of prior therapies  
Median (Full Range)
Unit of measure:  Number of prior therapies
Number Analyzed 124 participants
2
(1 to 5)
ECOG (Eastern Cooperative Oncology Group) performance status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 124 participants
0
71
  57.3%
1
44
  35.5%
2
8
   6.5%
3
1
   0.8%
[1]
Measure Description:

Performance Status Score (reference http://www.ecog.org/general/perf_stat.html):

0-Fully active, able to carry on all pre-disease performance

  1. Restricted physically strenuous activity but ambulatory and able to carry out work of a light/sedentary nature, eg light house/office work
  2. Ambulatory, capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours
  3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours
  4. Completely disabled Cannot carry on any self-care Totally confined to bed/chair
  5. Dead
1.Primary Outcome
Title Overall Response Rate (ORR) of ACP-196 (Acalabrutinib) in Subjects With Previously Treated MCL.
Hide Description The overall response rate (ORR) is defined as the proportion of subjects achieving either a partial remission (response) (PR) or complete response (CR) according to the Lugano Classification for NHL (Cheson 2014) as assessed by investigators, where SD stands for Stable Disease, PD for Progressive Disease and NE for Not Evaluable.
Time Frame Participants will be followed every 28 days or until progression of disease or start of another anti-cancer treatment for at least 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ACP-196 (Acalabrutinib)
Hide Arm/Group Description:
ACP-196 (acalabrutinib) 100 mg BID
Overall Number of Participants Analyzed 124
Measure Type: Count of Participants
Unit of Measure: Participants
CR
49
  39.5%
PR
51
  41.1%
SD
11
   8.9%
PD
10
   8.1%
NE
3
   2.4%
Time Frame From the first dose until within 30 days following the last dose of study drug, with median average of 14.8 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ACP-196 (Acalabrutinib)
Hide Arm/Group Description ACP-196 (acalabrutinib) 100 mg BID
All-Cause Mortality
ACP-196 (Acalabrutinib)
Affected / at Risk (%)
Total   27/124 (21.77%) 
Show Serious Adverse Events Hide Serious Adverse Events
ACP-196 (Acalabrutinib)
Affected / at Risk (%)
Total   48/124 (38.71%) 
Blood and lymphatic system disorders   
Anaemia  1  4/124 (3.23%) 
Leukostasis syndrome  1  1/124 (0.81%) 
Cardiac disorders   
Acute coronary syndrome  1  1/124 (0.81%) 
Acute myocardial infarction  1  1/124 (0.81%) 
Cardiac failure  1  1/124 (0.81%) 
Cardio-respiratory arrest  1  1/124 (0.81%) 
Gastrointestinal disorders   
Vomiting  1  2/124 (1.61%) 
Colitis  1  1/124 (0.81%) 
Diarrhoea  1  1/124 (0.81%) 
Gastrointestinal haemorrhage  1  1/124 (0.81%) 
Inguinal hernia strangulated  1  1/124 (0.81%) 
Intestinal obstruction  1  1/124 (0.81%) 
Nausea  1  1/124 (0.81%) 
General disorders   
General physical health deterioration  1  3/124 (2.42%) 
Chest pain  1  1/124 (0.81%) 
Non-cardiac chest pain  1  1/124 (0.81%) 
Peripheral swelling  1  1/124 (0.81%) 
Pyrexia  1  1/124 (0.81%) 
Hepatobiliary disorders   
Cholecystitis  1  1/124 (0.81%) 
Jaundice cholestatic  1  1/124 (0.81%) 
Infections and infestations   
Pneumonia  1  5/124 (4.03%) 
Sepsis  1  2/124 (1.61%) 
Arthritis bacterial  1  1/124 (0.81%) 
Catheter site infection  1  1/124 (0.81%) 
Gastroenteritis viral  1  1/124 (0.81%) 
Paronychia  1  1/124 (0.81%) 
Pharyngitis  1  1/124 (0.81%) 
Respiratory syncytial virus infection  1  1/124 (0.81%) 
Respiratory tract infection  1  1/124 (0.81%) 
Injury, poisoning and procedural complications   
Fall  1  1/124 (0.81%) 
Humerus fracture  1  1/124 (0.81%) 
Radius fracture  1  1/124 (0.81%) 
Tibia fracture  1  1/124 (0.81%) 
Transfusion reaction  1  1/124 (0.81%) 
Metabolism and nutrition disorders   
Tumour lysis syndrome  1  2/124 (1.61%) 
Decreased appetite  1  1/124 (0.81%) 
Lactic acidosis  1  1/124 (0.81%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
B-cell lymphoma  1  1/124 (0.81%) 
Invasive ductal breast carcinoma  1  1/124 (0.81%) 
Metastases to meninges  1  1/124 (0.81%) 
Non-small cell lung cancer  1  1/124 (0.81%) 
Nervous system disorders   
Altered state of consciousness  1  1/124 (0.81%) 
Headache  1  1/124 (0.81%) 
Renal and urinary disorders   
Hydronephrosis  1  1/124 (0.81%) 
Reproductive system and breast disorders   
Prostatitis  1  1/124 (0.81%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  1/124 (0.81%) 
Interstitial lung disease  1  1/124 (0.81%) 
Pleural effusion  1  1/124 (0.81%) 
Pulmonary fibrosis  1  1/124 (0.81%) 
Skin and subcutaneous tissue disorders   
Acute febrile neutrophilic dermatosis  1  1/124 (0.81%) 
Vascular disorders   
Aortic stenosis  1  1/124 (0.81%) 
Hypotension  1  1/124 (0.81%) 
Peripheral ischaemia  1  1/124 (0.81%) 
1
Term from vocabulary, MedDRA (19.1)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ACP-196 (Acalabrutinib)
Affected / at Risk (%)
Total   120/124 (96.77%) 
Blood and lymphatic system disorders   
Anaemia  1  13/124 (10.48%) 
Neutropenia  1  13/124 (10.48%) 
Eye disorders   
Vision blurred  1  8/124 (6.45%) 
Lacrimation increased  1  7/124 (5.65%) 
Gastrointestinal disorders   
Diarrhoea  1  38/124 (30.65%) 
Nausea  1  22/124 (17.74%) 
Constipation  1  17/124 (13.71%) 
Vomiting  1  15/124 (12.10%) 
Abdominal pain  1  9/124 (7.26%) 
Abdominal pain upper  1  9/124 (7.26%) 
Stomatitis  1  8/124 (6.45%) 
General disorders   
Fatigue  1  34/124 (27.42%) 
Pyrexia  1  18/124 (14.52%) 
Asthenia  1  18/124 (14.52%) 
Oedema peripheral  1  8/124 (6.45%) 
Infections and infestations   
Sinusitis  1  12/124 (9.68%) 
Nasopharyngitis  1  8/124 (6.45%) 
Upper respiratory tract infection  1  8/124 (6.45%) 
Bronchitis  1  7/124 (5.65%) 
Injury, poisoning and procedural complications   
Contusion  1  16/124 (12.90%) 
Metabolism and nutrition disorders   
Decreased appetite  1  8/124 (6.45%) 
Musculoskeletal and connective tissue disorders   
Myalgia  1  26/124 (20.97%) 
Arthralgia  1  9/124 (7.26%) 
Muscle spasms  1  9/124 (7.26%) 
Musculoskeletal pain  1  9/124 (7.26%) 
Back pain  1  7/124 (5.65%) 
Nervous system disorders   
Headache  1  47/124 (37.90%) 
Dizziness  1  15/124 (12.10%) 
Paraesthesia  1  10/124 (8.06%) 
Memory Impairment  1  7/124 (5.65%) 
Psychiatric disorders   
Insomnia  1  8/124 (6.45%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  24/124 (19.35%) 
Dyspnoea  1  10/124 (8.06%) 
Epistaxis  1  8/124 (6.45%) 
Skin and subcutaneous tissue disorders   
Rash  1  16/124 (12.90%) 
Erythema  1  7/124 (5.65%) 
Petechiae  1  11/124 (8.87%) 
1
Term from vocabulary, MedDRA (19.1)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Edwin Tucker, Senior Vice President, Clinical Development and Medical Safety
Organization: Acerta Pharma
Phone: 650-591-2800 X108
Responsible Party: Acerta Pharma BV
ClinicalTrials.gov Identifier: NCT02213926     History of Changes
Other Study ID Numbers: ACE-LY-004
First Submitted: August 5, 2014
First Posted: August 12, 2014
Results First Submitted: August 16, 2018
Results First Posted: October 19, 2018
Last Update Posted: July 10, 2019