Pancreatic cancer is the eighth most common cause of cancer-related death worldwide, associated with a 5-year survival rate of 5-6%. A vast majority of patients present with incurable advanced disease. Untreated metastatic disease is associated with a median survival time of 3 to 5 months and locally advanced disease with 6-10 months. Gemcitabine is currently regarded as the standard therapy for locally advanced or metastatic pancreatic cancer. MedDRA version: 16.0 Level: LLT Classification co
Conditions
Interventions
Product Name: BAY 86-9766
Product Code: BAY 86-9766 10 mg
Pharmaceutical Form: Capsule
CAS Number: 923032-37-5
Current Sponsor code: BAY 86-9766 micronized
Other descriptive name: RDEA 119
Concentrati
Sponsors
Bayer HealthCare AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female patients =18 years of age • Histological or cytologically confirmed locally advanced, inoperable or metastatic pancreatic adenocarcinoma not amenable to curative radiotherapy or surgery • Patients must have at least one uni-dimensional measurable lesion by CT or MRI according to RECIST, Version 1.1 • Resolution of all acute toxic effects of any prior local treatment to CTCAE Grade = 1 • Eastern Cooperative Oncology Group performance status (ECOG PS) = 2 • Patient has cardiac function, within normal range, as measured by an echocardiogram 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 28 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 28
Exclusion criteria
Exclusion criteria: • Known history of, or symptomatic metastatic brain or meningeal tumors (head CT or MRI at screening to confirm the absence of central nervous system [CNS] disease if patient has symptoms suggestive or consistent with CNS disease). • History of cardiac disease - Congestive heart failure New York Heart Association (NYHA) = Class 2; - Unstable angina (angina symptoms at rest, new-onset angina, ie, within the last 3 months) or myocardial infarction (MI) within the past 6 months prior to start of study treatment - Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted), or uncontrolled hypertension, (systolic blood pressure [BP] >150 mmHg or diastolic blood pressure >90 mmHg despite optimal medical management). • Active clinically serious infections (> Grade 2) •Clinically significant (ie, symptomatic) peripheral vascular disease Pregnant or lactating women; women of childbearing potential not employing adequate contraception. • Use of strong inhibitors of CYP3A4, (eg, ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir, nelfinavir and saquinavir), and strong inducers of CYP3A4 (eg, rifampin) • Prior systemic therapy for metastatic or locally advanced, unresectable pancreatic cancer, or other malignant conditions including cytotoxic chemotherapy, targeted agents, or any experimental therapy • Previous gemcitabine or 5-fluorouracil (5-FU) given concurrently as radiosensitizers to radiation therapy in adjuvant intention if given within 6 months from start of study treatment •Thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks) within 6 months prior to start of study treatment •History or current evidence of retinal vein occlusion (RVO) or central serous retinopathy (CSR) •Visible retinal pathology as assessed by ophthalmologic exam that is considered a risk factor for RVO or CSR
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase I: •Determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) of BAY 86-9766 to be investigated in combination with the standard gemcitabine regimen in the subsequent Phase II part of this study Phase II •Determine the efficacy of the combination BAY 86-9766 / gemcitabine in terms of the overall response rate (confirmed complete response + partial response) according to RECIST Version 1.1 ;Secondary Objective: Phase I: •Investigate the safety and tolerability and efficacy of up to three dose levels of BAY 86-9766 in combination with the standard gemcitabine regimen •Assess pharmacokinetics (PK) of gemcitabine and BAY 86-9766; if needed, PK assessments may also be performed in a limited number of patients in the Phase II part of this study. Phase II: •Response duration (DOR) •Disease control rate (DCR) •Time to progression (TTP) •Progression-free survival (PFS) •Overall survival (OS) •Asses safety and tolerability profile of the combination drug therapy •Determine patient reported outcome (pain evaluation) •Assess biomarkers ;Primary end point(s): Phase I: Determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) of BAY 86-9766 to be investigated in combination with the standard gemcitabine regimen in the subsequent Phase II part Phase II: Overall response rate (confirmed complete response + partial response) according to RECIST Version 1.1;Timepoint(s) of evaluation of this end point: Phase I tentative: first quarter 2012 Phase II tentative: last quarter 2013 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Belgium, Czech Republic, European Union, Germany, Italy, United Kingdom, United States
Contacts
Public ContactBayer Clinical Trials Contact
Bayer HealthCare AG
Outcome results
None listed