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

Phase 2

Terminated

• Conditions: Metastatic Pancreatic Cancer
• Interventions: Drug: ACP-196; Drug: Nab-paclitaxel; Drug: Gemcitabine

• Registration Number: NCT02570711
• Lead Sponsor: Acerta Pharma BV

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

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 Timeline

• Study First Submitted: 2015-10-05
• Study First Submitted QC: 2015-10-06
• Study First Posted: 2015-10-07
• Study Start: 2015-10-13
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Results First Submitted: 2019-07-25
• Status Verified: 2019-08
• Results First Submitted QC: 2019-08-23
• Last Update Submitted: 2019-08-23
• Results First Posted: 2019-08-28
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Regimen 1	Nab-paclitaxel	ACP-196 and nab-paclitaxel and gemcitabine
Regimen 2	Nab-paclitaxel	Nab-paclitaxel and gemcitabine
Regimen 1	ACP-196	ACP-196 and nab-paclitaxel and gemcitabine
Regimen 1	Gemcitabine	ACP-196 and nab-paclitaxel and gemcitabine
Regimen 2	Gemcitabine	Nab-paclitaxel and gemcitabine

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (9)

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Florida Cancer Specialists; 🇺🇸 Fort Myers, Florida, United States

Ventura Clinical Trials; 🇺🇸 Ventura, California, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Tennessee Oncology; 🇺🇸 Nashville, Tennessee, United States

The Center for Cancer and Blood Disorders; 🇺🇸 Fort Worth, Texas, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Oncology Hematology Care; 🇺🇸 Cincinnati, Ohio, United States

International Cancer Center; 🇺🇸 Houston, Texas, United States