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

NCT02570711 | Terminated Phase 2 Results

• 1 other identifier: ACE-ST-004
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 10

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

Conditions

Metastatic Pancreatic Cancer

Keywords

Acalabrutinib

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Regimen 1

EXPERIMENTAL

ACP-196 and nab-paclitaxel and gemcitabine

Drug: ACP-196; Drug: Nab-paclitaxel; Drug: Gemcitabine

Regimen 2

EXPERIMENTAL

Nab-paclitaxel and gemcitabine

Drug: Nab-paclitaxel; Drug: Gemcitabine

Interventions

ACP-196 DRUG

ACP-196 capsule

Also known as: acalabrutinib

Regimen 1

Nab-paclitaxel DRUG

Nab-paclitaxel infusion

Also known as: ABRAXANE

Regimen 1; Regimen 2

Gemcitabine DRUG

Gemcitabine infusion

Also known as: Gemzar

Regimen 1; Regimen 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Acerta Pharma BV: lead

Study Sites (10)

Ventura Clinical Trials

Ventura, California, 93003, United States

Location

Florida Cancer Specialists

Fort Myers, Florida, 33916, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Oncology Hematology Care

Cincinnati, Ohio, 45242-5665, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Tennessee Oncology

Chattanooga, Tennessee, 37404, United States

Location

Tennessee Oncology

Nashville, Tennessee, 37205, United States

Location

The Center for Cancer and Blood Disorders

Fort Worth, Texas, 76104, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030-4000, United States

Location

International Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

acalabrutinib; 130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Priti Patel, MD, Vice President - Head of Clinical Development
• Organization: Acerta Pharma, LLC

acertamc@dlss.com

1-888-292-9613

Study Officials

• Acerta Clinical Trial

  1-888-292-9613; acertamc@dlss.com

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2015
• First Posted: October 7, 2015
• Study Start: October 13, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: August 28, 2019
• Results First Posted: August 28, 2019

Record last verified: 2019-08

Locations

US (10)