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

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ClinicalTrials.gov Identifier: NCT02570711
Recruitment Status : Terminated (Sponsor Decision)
First Posted : October 7, 2015
Results First Posted : August 26, 2019
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Metastatic Pancreatic Cancer Drug: ACP-196 Drug: Nab-paclitaxel Drug: Gemcitabine 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : October 13, 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016


Arm Intervention/treatment
Experimental: Regimen 1
ACP-196 and nab-paclitaxel and gemcitabine
Drug: ACP-196
ACP-196 capsule
Other Name: acalabrutinib

Drug: Nab-paclitaxel
Nab-paclitaxel infusion
Other Name: ABRAXANE

Drug: Gemcitabine
Gemcitabine infusion
Other Name: Gemzar

Experimental: Regimen 2
Nab-paclitaxel and gemcitabine
Drug: Nab-paclitaxel
Nab-paclitaxel infusion
Other Name: ABRAXANE

Drug: Gemcitabine
Gemcitabine infusion
Other Name: Gemzar




Primary Outcome Measures :
  1. Overall Response Rate (ORR) [ 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. ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02570711


Locations
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United States, California
Ventura Clinical Trials
Ventura, California, United States, 93003
United States, Florida
Florida Cancer Specialists
Fort Myers, Florida, United States, 33916
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Oncology Hematology Care
Cincinnati, Ohio, United States, 45242-5665
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Tennessee
Tennessee Oncology
Chattanooga, Tennessee, United States, 37404
Tennessee Oncology
Nashville, Tennessee, United States, 37205
United States, Texas
The Center for Cancer and Blood Disorders
Fort Worth, Texas, United States, 76104
MD Anderson Cancer Center
Houston, Texas, United States, 77030-4000
International Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Acerta Pharma BV
Investigators
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Study Director: Acerta Clinical Trial 1-888-292-9613; acertamc@dlss.com
  Study Documents (Full-Text)

Documents provided by Acerta Pharma BV:

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Responsible Party: Acerta Pharma BV
ClinicalTrials.gov Identifier: NCT02570711     History of Changes
Other Study ID Numbers: ACE-ST-004
First Posted: October 7, 2015    Key Record Dates
Results First Posted: August 26, 2019
Last Update Posted: August 26, 2019
Last Verified: August 2019
Keywords provided by Acerta Pharma BV:
Acalabrutinib
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Gemcitabine
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs