Phase 2, Nab Paclitaxel/Gemcitabine Alone and in Combination With ACP-196 in Subjects With Metastatic Pancreatic Cancer
Study Details
Study Description
Brief 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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Regimen 1 ACP-196 and nab-paclitaxel and gemcitabine |
Drug: ACP-196
ACP-196 capsule
Other Names:
Drug: Nab-paclitaxel
Nab-paclitaxel infusion
Other Names:
Drug: Gemcitabine
Gemcitabine infusion
Other Names:
|
| Experimental: Regimen 2 Nab-paclitaxel and gemcitabine |
Drug: Nab-paclitaxel
Nab-paclitaxel infusion
Other Names:
Drug: Gemcitabine
Gemcitabine infusion
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Overall Response Rate (ORR) [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
Eligibility Criteria
Criteria
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:
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ventura Clinical Trials | Ventura | California | United States | 93003 |
| 2 | Florida Cancer Specialists | Fort Myers | Florida | United States | 33916 |
| 3 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
| 4 | Oncology Hematology Care | Cincinnati | Ohio | United States | 45242-5665 |
| 5 | Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
| 6 | Tennessee Oncology | Chattanooga | Tennessee | United States | 37404 |
| 7 | Tennessee Oncology | Nashville | Tennessee | United States | 37205 |
| 8 | The Center for Cancer and Blood Disorders | Fort Worth | Texas | United States | 76104 |
| 9 | MD Anderson Cancer Center | Houston | Texas | United States | 77030-4000 |
| 10 | International Cancer Center | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- Acerta Pharma BV
Investigators
- Study Director: Acerta Clinical Trial, 1-888-292-9613; acertamc@dlss.com
Study Documents (Full-Text)
More Information
Publications
None provided.- ACE-ST-004
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Arm 1 - ACP-196 and Nab-Paclitaxel and Gemcitabine | Arm 2 - Nab-Paclitaxel and Gemcitabine |
|---|---|---|
| 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 |
Baseline Characteristics
| Arm/Group Title | Arm 1- ACP-196 and Nab-Paclitaxel and Gemcitabine | Arm 2 - Nab-Paclitaxel and Gemcitabine | Total |
|---|---|---|---|
| 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 Participants | 1 | 2 | 3 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
1
100%
|
1
50%
|
2
66.7%
|
| >=65 years |
0
0%
|
1
50%
|
1
33.3%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
1
100%
|
2
100%
|
3
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
| Not Hispanic or Latino |
1
100%
|
2
100%
|
3
100%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
| White |
0
0%
|
2
100%
|
2
66.7%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
1
100%
|
0
0%
|
1
33.3%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
1
100%
|
2
100%
|
3
100%
|
| ECOG Performance Status (participants) [Number] | |||
| ECOG - 0 |
0
0%
|
1
50%
|
1
33.3%
|
| ECOG = 1 |
1
100%
|
1
50%
|
2
66.7%
|
| Subjects who have previously untreated metastatic pancreatic cancer (Count of Participants) | |||
| Count of Participants [Participants] |
1
100%
|
2
100%
|
3
100%
|
Outcome Measures
| Title | Overall Response Rate (ORR) |
|---|---|
| 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Arm 1- ACP-196 and Nab-Paclitaxel and Gemcitabine | Arm 2 - Nab-Paclitaxel and Gemcitabine |
|---|---|---|
| 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 |
| Measure Participants | 1 | 2 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Arm 1 - ACP-196 and Nab-Paclitaxel and Gemcitabine | Arm 2 - Nab-Paclitaxel and Gemcitabine | ||
| 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 (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/1 (100%) | 0/2 (0%) | ||
Serious Adverse Events |
||||
| Arm 1 - ACP-196 and Nab-Paclitaxel and Gemcitabine | Arm 2 - Nab-Paclitaxel and Gemcitabine | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/1 (100%) | 0/2 (0%) | ||
| Infections and infestations | ||||
| Septic Shock | 1/1 (100%) | 0/2 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Arm 1 - ACP-196 and Nab-Paclitaxel and Gemcitabine | Arm 2 - Nab-Paclitaxel and Gemcitabine | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/1 (100%) | 2/2 (100%) | ||
| Blood and lymphatic system disorders | ||||
| Febrile Neutropenia | 1/1 (100%) | 0/2 (0%) | ||
| Neutropenia | 1/1 (100%) | 0/2 (0%) | ||
| Thrombocytopenia | 0/1 (0%) | 1/2 (50%) | ||
| Gastrointestinal disorders | ||||
| Nausea | 1/1 (100%) | 0/2 (0%) | ||
| Oral Pain | 0/1 (0%) | 1/2 (50%) | ||
| General disorders | ||||
| Fatigue | 0/1 (0%) | 1/2 (50%) | ||
| Infusion Site Extravasation | 0/1 (0%) | 1/2 (50%) | ||
| Peripheral Swelling | 0/1 (0%) | 1/2 (50%) | ||
| Metabolism and nutrition disorders | ||||
| Hyperglycaemia | 1/1 (100%) | 0/2 (0%) | ||
| Hypoalbuminaemia | 1/1 (100%) | 0/2 (0%) | ||
| Hypocalcaemia | 1/1 (100%) | 0/2 (0%) | ||
| Hypoglycaemia | 1/1 (100%) | 0/2 (0%) | ||
| Hypokalaemia | 0/1 (0%) | 1/2 (50%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Joint Swelling | 0/1 (0%) | 1/2 (50%) | ||
| Pain in Extremity | 0/1 (0%) | 1/2 (50%) | ||
| Nervous system disorders | ||||
| Dizziness | 0/1 (0%) | 1/2 (50%) | ||
| Hepatic Encephalopathy | 1/1 (100%) | 0/2 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Dyspnoea | 1/1 (100%) | 0/2 (0%) | ||
| Epistaxis | 0/1 (0%) | 1/2 (50%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Alopecia | 1/1 (100%) | 0/2 (0%) | ||
| Vascular disorders | ||||
| Hypotension | 1/1 (100%) | 0/2 (0%) | ||
Limitations/Caveats
More Information
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 | Priti Patel, MD, Vice President - Head of Clinical Development |
|---|---|
| Organization | Acerta Pharma, LLC |
| Phone | 1-888-292-9613 |
| acertamc@dlss.com |
- ACE-ST-004