Metastatic Pancreatic Cancer MedDRA version: 18.1 Level: LLT Classification code 10033605 Term: Pancreatic cancer metastatic System Organ Class: 100000004864
Conditions
Interventions
Product Name: ACP-196
Pharmaceutical Form: Capsule
INN or Proposed INN: Acalabrutinib
CAS Number: 1420477-60-6
Current Sponsor code: ACP-196
Other descriptive name: ACP-196
Concentration unit: mg mill
Sponsors
Acerta Pharma BV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Men and women = 18 years of age. 2) ECOG performance status of 0 or 1. 3) Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas. 4) Presence of radiographically measurable disease per RECIST 1.1. guidelines. 5) 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. 6) Women who are sexually active and can bear children must agree to use highly effective forms of contraception during the study and for 90 days after the last dose of ACP-196 or 4 months after the last dose of nab-paclitaxel/gemcitabine, whichever is longer. Highly effective forms of contraception are defined in protocol section 3.10.4. 7) Men who are sexually active and can beget children must agree to use highly effective forms of contraception during the study and for 90 days after the last dose of ACP-196 or 4 months after the last dose of nab-paclitaxel/gemcitabine, whichever is longer. Highly effective forms of contraception are defined in protocol section 3.10.4. 8) Men must agree to refrain from sperm donation during the study and for 90 days after the last dose of ACP-196 or 4 months after the last dose of nab-paclitaxel/gemcitabine, whichever is longer. 9) Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty 10) Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local subject privacy regulations) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 42 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 78
Exclusion criteria
Exclusion criteria: 1) 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 . Note: These cases must be discussed with the medical monitor. 2) Known CNS metastases and/or carcinomatous meningitis. 3) Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or QTc > 480 msec at screening. 4) 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. Note: Subjects with prior pancreatoduodenectomy are not excluded. 5) 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. 6) Prior therapy with any inhibitor of Btk, Akt, Jak, mTOR, PI3K, or Syk. 7) History of interstitial lung disease or active non-infectious pneumonitis. 8) History of bleeding diathesis (eg, hemophilia or von Willebrand disease). 9) Major surgical procedure within 28 days of first dose of study drug. 10) Known hypersensitivity to gemcitabine or nab-paclitaxel. 11) Requires treatment with a proton pump inhibitors (eg, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). 12) Requires treatment with a strong CYP3A4 or CYP2C8 inhibitor/inducer. 13) Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists (eg, phenprocoumon) within 7 days of first dose of study drug. 14) Ongoing immunosuppressive therapy, including systemic or enteric corticosteroids. Note: At screening and during study participation, subjects may use topical or inhaled corticosteroids or systemic corticosteroids at dosages equivalent to prednisone = 10 mg/day as therapy for comorbid conditions. 15) Known history of HIV or active infection with HCV or HBV or any active infection requiring systemic therapy with 14 days of randomization. 16) History of stroke or intracranial hemorrhage within 6 months before the first dose of study drug. 17) ANC ULN; and AST or ALT > 3.0 x ULN. 19) PT and aPTT > 1.2 x the ULN. 20) Estimated creatinine clearance of < 30 mL/min, calculated using the formula of Cockcroft and Gault (140-Age) • Mass (kg)/(72 • creatinine mg/dL); multiply by 0.85 if female. 21) Breastfeeding or pregnant. 22) Concurrent participation in another therapeutic clinical trial. 23) Presence of a gastrointestinal ulcer diagnosed by endoscopy within 3 months before screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Overall response rate (ORR) is the primary efficacy endpoint.;Timepoint(s) of evaluation of this end point: Tumor assessments will be performed per the protocol-defined schedule: at screening, then on Day 1 of every other cycle starting with Cycle 3 (eg, Cycle 3 Day 1, Cycle 5 Day 1, etc.);Main Objective: To evaluate the efficacy of ACP-196 and nab-paclitaxel/gemcitabine based on ORR in subjects with metastatic pancreatic cancer using standard response criteria;Secondary Objective: To characterize the safety profile of ACP-196 and nab-paclitaxel/gemcitabine in subjects with metastatic pancreatic cancer | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): In addition, the following efficacy endpoints will be evaluated: Duration of response (DOR), progression-free survival (PFS), and overall survival (OS) ;Timepoint(s) of evaluation of this end point: DOR and PFS will be evaluated per the same tumor assessment schedule as described for ORR (per the protocol). In addition to the protocol-defined visits, subjects will be followed for OS every 12 weeks after study treatment discontinuation. | — |
Countries
Austria, Belgium, Canada, Germany, Spain, United States
Contacts
Public ContactMedical Director
Acerta
Outcome results
None listed