TerminatedNCT02570711Updated Aug 28, 2019Results posted

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

A Phase 2 interventional study of ACP-196 and Nab-paclitaxel in Metastatic Pancreatic Cancer, sponsored by Acerta Pharma BV. Terminated at 10 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-28.

Sponsored by Acerta Pharma BV (part of AstraZeneca) · Phase 2, Interventional, and Treatment

Why this study was terminated

Sponsor Decision

Phase: Phase 2
Study type: Interventional
Enrollment: 3
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

To evaluate the safety and efficacy of ACP-196 and nab paclitaxel/gemcitabine in subjects with previously untreated metastatic pancreatic cancer using standard response criteria

Read the detailed description

A Phase 2, multicenter, open-label, randomized clinical trial. The study was to evaluate the efficacy and safety of ACP-196 plus nab-paclitaxel/gemcitabine compared with nab-paclitaxel/gemcitabine in subjects who have previously untreated metastatic pancreatic cancer.

Conditions studied

Metastatic Pancreatic Cancer

Browse trials for

Pancreatic Neoplasms 3,310

Keywords

Acalabrutinib

In context

Pancreatic Neoplasms

3,310 studies on the registry are indexed under Pancreatic Neoplasms; 910 are open to participants now.

This study's enrollment of 3 is below the median of 46 across 2,480 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Acerta Pharma BV is the lead sponsor of 41 studies on the registry; none are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 3 (25%) have results posted.

First submitted before Acerta Pharma BV became part of AstraZeneca.

Browse Acerta Pharma BV studies →All AstraZeneca studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Men and women ≥ 18 years of age.
ECOG performance status of 0 or 1.
Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas.
No previous radiotherapy, chemotherapy or investigational therapy for the treatment of metastatic disease. Prior treatment with 5-FU or gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present.

Exclusion criteria

Exclusion Criteria:

Prior malignancy (other than pancreatic cancer), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥ 2 years or which will not limit survival to \< 2 years.
Known central nervous system (CNS) metastases and/or carcinomatous meningitis.
Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening
Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass.
Biliary obstruction or presence of a percutaneous biliary drain. Note: Subjects with endobiliary stents may participate as long the enrollment criterion relating to serum bilirubin concentration is met.
Breastfeeding or pregnant

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Outcomes assessor)
Enrollment: 3 participants (actual)

Study arms

Experimental
Regimen 1
ACP-196 and nab-paclitaxel and gemcitabine
Drug: ACP-196 · Drug: Nab-paclitaxel · Drug: Gemcitabine
Experimental
Regimen 2
Nab-paclitaxel and gemcitabine
Drug: Nab-paclitaxel · Drug: Gemcitabine

Interventions

DrugACP-196
ACP-196 capsule
Also known as: acalabrutinib
DrugNab-paclitaxel
Nab-paclitaxel infusion
Also known as: ABRAXANE
DrugGemcitabine
Gemcitabine infusion
Also known as: Gemzar

What researchers measure

Primary outcomes

Overall Response Rate (ORR)
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.

Results

Posted Aug 28, 2019

Participant flow

Participant flow — Overall Study
Milestone	Arm 1 - ACP-196 and Nab-Paclitaxel and Gemcitabine	Arm 2 - Nab-Paclitaxel and Gemcitabine
Started	1	2
Completed	0	0
Not completed	1	2
Withdrew: Death	1	0
Withdrew: Early termination of study by sponsor	0	2

Outcome measures

PrimaryOverall Response Rate (ORR)

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.
Reported as:: Count of participants · Participants

Overall Response Rate (ORR)
Participants	Arm 1- ACP-196 and Nab-Paclitaxel and Gemcitabine	Arm 2 - Nab-Paclitaxel and Gemcitabine
Overall Response Rate (ORR)	0	0

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Arm 1 - ACP-196 and Nab-Paclitaxel and Gemcitabine	1/1 (100%)	1/1 (100%)	1/1 (100%)
Arm 2 - Nab-Paclitaxel and Gemcitabine	0/2 (0%)	0/2 (0%)	2/2 (100%)

Most frequent serious events

Most frequent serious events
Event	Arm 1 - ACP-196 and Nab-Paclitaxel and Gemcitabine	Arm 2 - Nab-Paclitaxel and Gemcitabine
Septic ShockInfections and infestations	1/1	0/2

Most frequent other events

Showing 10 of 21

Most frequent other events
Event	Arm 1 - ACP-196 and Nab-Paclitaxel and Gemcitabine	Arm 2 - Nab-Paclitaxel and Gemcitabine
Febrile NeutropeniaBlood and lymphatic system disorders	1/1	0/2
NeutropeniaBlood and lymphatic system disorders	1/1	0/2
NauseaGastrointestinal disorders	1/1	0/2
HyperglycaemiaMetabolism and nutrition disorders	1/1	0/2
HypoalbuminaemiaMetabolism and nutrition disorders	1/1	0/2
HypocalcaemiaMetabolism and nutrition disorders	1/1	0/2
HypoglycaemiaMetabolism and nutrition disorders	1/1	0/2
Hepatic EncephalopathyNervous system disorders	1/1	0/2
DyspnoeaRespiratory, thoracic and mediastinal disorders	1/1	0/2
AlopeciaSkin and subcutaneous tissue disorders	1/1	0/2

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Arm 1- ACP-196 and Nab-Paclitaxel and Gemcitabine	Arm 2 - Nab-Paclitaxel and Gemcitabine	Total
<=18 years	0	0	0
Between 18 and 65 years	1	1	2
>=65 years	0	1	1

Sex: Female, Male
Sex: Female, Male(Participants)	Arm 1- ACP-196 and Nab-Paclitaxel and Gemcitabine	Arm 2 - Nab-Paclitaxel and Gemcitabine	Total
Female	1	2	3
Male	0	0	0

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Arm 1- ACP-196 and Nab-Paclitaxel and Gemcitabine	Arm 2 - Nab-Paclitaxel and Gemcitabine	Total
Hispanic or Latino	0	0	0
Not Hispanic or Latino	1	2	3
Unknown or Not Reported	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Arm 1- ACP-196 and Nab-Paclitaxel and Gemcitabine	Arm 2 - Nab-Paclitaxel and Gemcitabine	Total
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	0	0	0
White	0	2	2
More than one race	0	0	0
Unknown or Not Reported	1	0	1

Region of Enrollment
Region of Enrollment(participants)	Arm 1- ACP-196 and Nab-Paclitaxel and Gemcitabine	Arm 2 - Nab-Paclitaxel and Gemcitabine	Total
United States	1	2	3

ECOG Performance Status
ECOG Performance Status(participants)	Arm 1- ACP-196 and Nab-Paclitaxel and Gemcitabine	Arm 2 - Nab-Paclitaxel and Gemcitabine	Total
ECOG - 0	0	1	1
ECOG = 1	1	1	2

Subjects who have previously untreated metastatic pancreatic cancer
Subjects who have previously untreated metastatic pancreatic cancer(Participants)	Arm 1- ACP-196 and Nab-Paclitaxel and Gemcitabine	Arm 2 - Nab-Paclitaxel and Gemcitabine	Total
Count of participants	1	2	3

Study locations

10 sites

Ventura Clinical Trials
Ventura, California 93003, United States
Florida Cancer Specialists
Fort Myers, Florida 33916, United States
Duke University Medical Center
Durham, North Carolina 27710, United States
Oncology Hematology Care
Cincinnati, Ohio 45242-5665, United States
Cleveland Clinic
Cleveland, Ohio 44195, United States
Tennessee Oncology
Chattanooga, Tennessee 37404, United States
Tennessee Oncology
Nashville, Tennessee 37205, United States
The Center for Cancer and Blood Disorders
Fort Worth, Texas 76104, United States
MD Anderson Cancer Center
Houston, Texas 77030-4000, United States
International Cancer Center
Houston, Texas 77030, United States

References and documents

Study documents

Protocol and statistical analysis plan · Feb 1, 2016

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 28, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02570711
Lead sponsor: Acerta Pharma BV
Responsible party: Sponsor
First posted: Oct 7, 2015
Start date: Oct 13, 2015
Primary completion: Apr 2016
Completion: Apr 2016
Results posted: Aug 28, 2019
Last update: Aug 28, 2019

Study contacts

Acerta Clinical Trial

study director · 1-888-292-9613; acertamc@dlss.com

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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