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

Metastatic Pancreatic Cancer Clinical Trial

Official title:

A Phase 2, Randomized, Proof-of-Concept Study of Nab-Paclitaxel/Gemcitabine Alone and in Combination With ACP-196 in Subjects With Previously Untreated Metastatic Pancreatic Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02570711
• Other study ID #: ACE-ST-004
• Status: Terminated
• Phase: Phase 2
• Start date: October 13, 2015
• Est. completion date: April 2016

Study information

• Verified date: August 2019
• Source: Acerta Pharma BV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• ACP-196
ACP-196 capsule
• Nab-paclitaxel
Nab-paclitaxel infusion
• Gemcitabine
Gemcitabine infusion

Locations

Country	Name	City	State
United States	Tennessee Oncology	Chattanooga	Tennessee
United States	Oncology Hematology Care	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	Florida Cancer Specialists	Fort Myers	Florida
United States	The Center for Cancer and Blood Disorders	Fort Worth	Texas
United States	International Cancer Center	Houston	Texas
United States	MD Anderson Cancer Center	Houston	Texas
United States	Tennessee Oncology	Nashville	Tennessee
United States	Ventura Clinical Trials	Ventura	California

Sponsors (1)

Lead Sponsor	Collaborator
Acerta Pharma BV

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	At screening, Cycle 3, and Day 1 of every other cycle afterwards (e.g., Cycle 5 Day 1). Every cycle is 28 days.