Trial Outcomes & Findings for Phase 2, Nab Paclitaxel/Gemcitabine Alone and in Combination With ACP-196 in Subjects With Metastatic Pancreatic Cancer (NCT NCT02570711)
NCT ID: NCT02570711
Last Updated: 2019-08-28
Results Overview
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
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
3 participants
Primary outcome timeframe
At screening, Cycle 3, and Day 1 of every other cycle afterwards (e.g., Cycle 5 Day 1). Every cycle is 28 days.
Results posted on
2019-08-28
Participant Flow
Participant milestones
| Measure |
Arm 1 - ACP-196 and Nab-Paclitaxel and Gemcitabine
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.
|
Arm 2 - Nab-Paclitaxel and Gemcitabine
Nab-Paclitaxel 125mg/m2 and gemcitabine 1000mg/m2 on Days 1,8, and 15; cycles repeated every 28 days.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Arm 1 - ACP-196 and Nab-Paclitaxel and Gemcitabine
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.
|
Arm 2 - Nab-Paclitaxel and Gemcitabine
Nab-Paclitaxel 125mg/m2 and gemcitabine 1000mg/m2 on Days 1,8, and 15; cycles repeated every 28 days.
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Early Termination of Study by Sponsor
|
0
|
2
|
Baseline Characteristics
Phase 2, Nab Paclitaxel/Gemcitabine Alone and in Combination With ACP-196 in Subjects With Metastatic Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Arm 1- ACP-196 and Nab-Paclitaxel and Gemcitabine
n=1 Participants
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.
|
Arm 2 - Nab-Paclitaxel and Gemcitabine
n=2 Participants
Nab-Paclitaxel 125mg/m2 and Gemcitabine 1000mg/m2 on Days 1,8, and 15; Cycles were repeated every 28 days.
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
ECOG Performance Status
ECOG - 0
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
ECOG Performance Status
ECOG = 1
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Subjects who have previously untreated metastatic pancreatic cancer
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At screening, Cycle 3, and Day 1 of every other cycle afterwards (e.g., Cycle 5 Day 1). Every cycle is 28 days.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
Outcome measures
| Measure |
Arm 1- ACP-196 and Nab-Paclitaxel and Gemcitabine
n=1 Participants
ACP-196 and nab-paclitaxel and gemcitabine
ACP-196: ACP-196 capsule
Nab-paclitaxel: Nab-paclitaxel infusion
Gemcitabine: Gemcitabine infusion
|
Arm 2 - Nab-Paclitaxel and Gemcitabine
n=2 Participants
Nab-paclitaxel and gemcitabine
Nab-paclitaxel: Nab-paclitaxel infusion
Gemcitabine: Gemcitabine infusion
|
|---|---|---|
|
Overall Response Rate (ORR)
|
0 Participants
|
0 Participants
|
Adverse Events
Arm 1 - ACP-196 and Nab-Paclitaxel and Gemcitabine
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Arm 2 - Nab-Paclitaxel and Gemcitabine
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1 - ACP-196 and Nab-Paclitaxel and Gemcitabine
n=1 participants at risk
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.
|
Arm 2 - Nab-Paclitaxel and Gemcitabine
n=2 participants at risk
Nab-Paclitaxel 125mg/m2 on Days 1,8, and 15; Cycles were repeated every 28 days.
|
|---|---|---|
|
Infections and infestations
Septic Shock
|
100.0%
1/1
|
0.00%
0/2
|
Other adverse events
| Measure |
Arm 1 - ACP-196 and Nab-Paclitaxel and Gemcitabine
n=1 participants at risk
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.
|
Arm 2 - Nab-Paclitaxel and Gemcitabine
n=2 participants at risk
Nab-Paclitaxel 125mg/m2 on Days 1,8, and 15; Cycles were repeated every 28 days.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
100.0%
1/1
|
0.00%
0/2
|
|
Blood and lymphatic system disorders
Neutropenia
|
100.0%
1/1
|
0.00%
0/2
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1
|
50.0%
1/2
|
|
Gastrointestinal disorders
Nausea
|
100.0%
1/1
|
0.00%
0/2
|
|
Gastrointestinal disorders
Oral Pain
|
0.00%
0/1
|
50.0%
1/2
|
|
General disorders
Fatigue
|
0.00%
0/1
|
50.0%
1/2
|
|
General disorders
Infusion Site Extravasation
|
0.00%
0/1
|
50.0%
1/2
|
|
General disorders
Peripheral Swelling
|
0.00%
0/1
|
50.0%
1/2
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
100.0%
1/1
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
100.0%
1/1
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
100.0%
1/1
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
100.0%
1/1
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/1
|
50.0%
1/2
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
0.00%
0/1
|
50.0%
1/2
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/1
|
50.0%
1/2
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1
|
50.0%
1/2
|
|
Nervous system disorders
Hepatic Encephalopathy
|
100.0%
1/1
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
100.0%
1/1
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/1
|
50.0%
1/2
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
100.0%
1/1
|
0.00%
0/2
|
|
Vascular disorders
Hypotension
|
100.0%
1/1
|
0.00%
0/2
|
Additional Information
Priti Patel, MD, Vice President - 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