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Phase 2, Nab Paclitaxel/Gemcitabine Alone and in Combination With ACP-196 in Subjects With Metastatic Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT02570711
Recruitment Status : Terminated (Sponsor Decision)
First Posted : October 7, 2015
Results First Posted : August 26, 2019
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
Acerta Pharma BV

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Metastatic Pancreatic Cancer
Interventions Drug: ACP-196
Drug: Nab-paclitaxel
Drug: Gemcitabine
Enrollment 3
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1 - ACP-196 and Nab-Paclitaxel and Gemcitabine Arm 2 - Nab-Paclitaxel and Gemcitabine
Hide Arm/Group Description Acalabrutinib 100mg PO BID on Day 1 to 28 with Nab-Paclitaxel 125mg/m2 and Gemcitabine 1000mg/m2 on Days 1,8, and 15; cycles were repeated every 28 days. Nab-Paclitaxel 125mg/m2 and gemcitabine 1000mg/m2 on Days 1,8, and 15; cycles repeated every 28 days.
Period Title: Overall Study
Started 1 2
Completed 0 0
Not Completed 1 2
Reason Not Completed
Death             1             0
Early Termination of Study by Sponsor             0             2
Arm/Group Title Arm 1- ACP-196 and Nab-Paclitaxel and Gemcitabine Arm 2 - Nab-Paclitaxel and Gemcitabine Total
Hide Arm/Group Description Acalabrutinib 100mg PO BID on Days 1 to 28 with Nab-Paclitaxel 125mg/m2 and Gemcitabine 1000mg/m2 on Days 1,8, and 15; cycles were repeated every 28 days. Nab-Paclitaxel 125mg/m2 and Gemcitabine 1000mg/m2 on Days 1,8, and 15; Cycles were repeated every 28 days. Total of all reporting groups
Overall Number of Baseline Participants 1 2 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 2 participants 3 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
 100.0%
1
  50.0%
2
  66.7%
>=65 years
0
   0.0%
1
  50.0%
1
  33.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 2 participants 3 participants
Female
1
 100.0%
2
 100.0%
3
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 2 participants 3 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
1
 100.0%
2
 100.0%
3
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 2 participants 3 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
2
 100.0%
2
  66.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
 100.0%
0
   0.0%
1
  33.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants 2 participants 3 participants
1 2 3
ECOG Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1 participants 2 participants 3 participants
ECOG - 0 0 1 1
ECOG = 1 1 1 2
[1]
Measure Description: The ECOG Scale of Performance Status is one such measurement. It describes a patient’s level of functioning in terms of their ability to care for themselves, daily activity, and physical ability (walking, working, etc.).
Subjects who have previously untreated metastatic pancreatic cancer   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 2 participants 3 participants
1
 100.0%
2
 100.0%
3
 100.0%
[1]
Measure Description: Subjects who have previously untreated metastatic pancreatic cancer and meet all inclusion and exclusion criteria
1.Primary Outcome
Title Overall Response Rate (ORR)
Hide Description The overall response rate (ORR) of ACP-196 plus nab-paclitaxel/gemcitabine compared with nab-paclitaxel/gemcitabine in patients with previously untreated metastatic pancreatic cancer
Time Frame At screening, Cycle 3, and Day 1 of every other cycle afterwards (e.g., Cycle 5 Day 1). Every cycle is 28 days.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1- ACP-196 and Nab-Paclitaxel and Gemcitabine Arm 2 - Nab-Paclitaxel and Gemcitabine
Hide Arm/Group Description:

ACP-196 and nab-paclitaxel and gemcitabine

ACP-196: ACP-196 capsule

Nab-paclitaxel: Nab-paclitaxel infusion

Gemcitabine: Gemcitabine infusion

Nab-paclitaxel and gemcitabine

Nab-paclitaxel: Nab-paclitaxel infusion

Gemcitabine: Gemcitabine infusion

Overall Number of Participants Analyzed 1 2
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1 - ACP-196 and Nab-Paclitaxel and Gemcitabine Arm 2 - Nab-Paclitaxel and Gemcitabine
Hide Arm/Group Description Acalabrutinib 100mg PO BID on Days 1 to 28 with Nab-Paclitaxel 125mg/m2 and Gemcitabine 1000mg/m2 on Days 1,8, and 15; Cycles were repeated every 28 days. Nab-Paclitaxel 125mg/m2 on Days 1,8, and 15; Cycles were repeated every 28 days.
All-Cause Mortality
Arm 1 - ACP-196 and Nab-Paclitaxel and Gemcitabine Arm 2 - Nab-Paclitaxel and Gemcitabine
Affected / at Risk (%) Affected / at Risk (%)
Total   1/1 (100.00%)   0/2 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1 - ACP-196 and Nab-Paclitaxel and Gemcitabine Arm 2 - Nab-Paclitaxel and Gemcitabine
Affected / at Risk (%) Affected / at Risk (%)
Total   1/1 (100.00%)   0/2 (0.00%) 
Infections and infestations     
Septic Shock   1/1 (100.00%)  0/2 (0.00%) 
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 0%
Arm 1 - ACP-196 and Nab-Paclitaxel and Gemcitabine Arm 2 - Nab-Paclitaxel and Gemcitabine
Affected / at Risk (%) Affected / at Risk (%)
Total   1/1 (100.00%)   2/2 (100.00%) 
Blood and lymphatic system disorders     
Febrile Neutropenia   1/1 (100.00%)  0/2 (0.00%) 
Neutropenia   1/1 (100.00%)  0/2 (0.00%) 
Thrombocytopenia   0/1 (0.00%)  1/2 (50.00%) 
Gastrointestinal disorders     
Nausea   1/1 (100.00%)  0/2 (0.00%) 
Oral Pain   0/1 (0.00%)  1/2 (50.00%) 
General disorders     
Fatigue   0/1 (0.00%)  1/2 (50.00%) 
Infusion Site Extravasation   0/1 (0.00%)  1/2 (50.00%) 
Peripheral Swelling   0/1 (0.00%)  1/2 (50.00%) 
Metabolism and nutrition disorders     
Hyperglycaemia   1/1 (100.00%)  0/2 (0.00%) 
Hypoalbuminaemia   1/1 (100.00%)  0/2 (0.00%) 
Hypocalcaemia   1/1 (100.00%)  0/2 (0.00%) 
Hypoglycaemia   1/1 (100.00%)  0/2 (0.00%) 
Hypokalaemia   0/1 (0.00%)  1/2 (50.00%) 
Musculoskeletal and connective tissue disorders     
Joint Swelling   0/1 (0.00%)  1/2 (50.00%) 
Pain in Extremity   0/1 (0.00%)  1/2 (50.00%) 
Nervous system disorders     
Dizziness   0/1 (0.00%)  1/2 (50.00%) 
Hepatic Encephalopathy   1/1 (100.00%)  0/2 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea   1/1 (100.00%)  0/2 (0.00%) 
Epistaxis   0/1 (0.00%)  1/2 (50.00%) 
Skin and subcutaneous tissue disorders     
Alopecia   1/1 (100.00%)  0/2 (0.00%) 
Vascular disorders     
Hypotension   1/1 (100.00%)  0/2 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Priti Patel, MD, Vice President - Head of Clinical Development
Organization: Acerta Pharma, LLC
Phone: 1-888-292-9613
EMail: acertamc@dlss.com
Layout table for additonal information
Responsible Party: Acerta Pharma BV
ClinicalTrials.gov Identifier: NCT02570711     History of Changes
Other Study ID Numbers: ACE-ST-004
First Submitted: October 5, 2015
First Posted: October 7, 2015
Results First Submitted: July 25, 2019
Results First Posted: August 26, 2019
Last Update Posted: August 26, 2019