Trial Condition(s):
Combination with gemcitabine in advanced pancreatic cancer (BAGPAC)
Open-label, uncontrolled, Phase I/II study to evaluate safety and efficacy of BAY86-9766 plus gemcitabine in locally advanced, unresectable or metastatic pancreatic cancer.
Phase I: Dose escalation study investigating 20, 30 and 50 mg BAY86-9766 plus gemcitabine (1000mg/m2); determination of maximum tolerated dose and recommended phase 2 dose.
Phase II: Determination of response (RECIST 1.1; primary endpoint). Secondary endpoints: response duration, disease control rate, time to progression, progression-free survival, overall survival, safety and tolerability.
Tumor assessments at Screening and than every 8 weeks.; Safety evaluations at Screening and weekly throughout the study; Safety follow-up visit 30 days after the last dose of study treatment; Survival follow up monthly for up to 8 month after LPFV.
- 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 Common Terminology Criteria for Adverse Events (CTCAE) Grade </= 1 - Eastern Cooperative Oncology Group performance status (ECOG PS) </= 2 - Patient has cardiac function, within normal range, as measured by an echocardiogram
- Known history of, or symptomatic metastatic brain or meningeal tumors - History of cardiac disease - Active clinically serious infections - Clinically significant (ie. symptomatic) peripheral vascular disease - Pregnant or lactating women; women of childbearing potential not employing adequate contraception - Use of strong inhibitors or inducers of CYP3A4 - Prior systemic therapy for metastatic or locally advanced, unresectable pancreatic cancer, or other malignancy - 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 within 6 months prior to start of study treatment
Locations | Status | ||
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Locations Investigative Site München, Germany, 81377 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Berlin, Germany, 13353 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site BRUXELLES - BRUSSEL, Belgium, 1070 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site EDEGEM, Belgium, 2650 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Olomouc, Czech Republic, 775 20 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Bochum, Germany, 44892 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Marburg, Germany, 35033 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Ancona, Italy, 60126 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Brescia, Italy, 25124 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site London, United Kingdom | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Oslo, Norway, 0310 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Oslo, Norway | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Aurora, United States, 80045 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site London, United Kingdom, SE1 9RT | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Brno, Czech Republic, 602 00 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Heilbronn, Germany, 74078 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site London, United Kingdom, WC1E 6BT | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Gdansk, Poland, 80-952 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Warszawa, Poland, 02-781 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site CLERMONT-FERRAND Cedex 1, France, 63003 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Pittsfield, United States, 01201 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site BRUXELLES - BRUSSEL, Belgium, 1090 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Bialystok, Poland, 15-027 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
A multi-center, phase I/II study of BAY86-9766 in combination with gemcitabine in patients with locally advanced inoperable or metastatic pancreatic cancer
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
N/A
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1