Status:
COMPLETED
Combination With Gemcitabine in Advanced Pancreatic Cancer
Lead Sponsor:
Bayer
Conditions:
Pancreatic Neoplasms
Eligibility:
All Genders
18-99 years
Phase:
PHASE1
PHASE2
Brief Summary
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 s...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT01251640
Start Date
January 1 2011
End Date
August 1 2013
Last Update
April 8 2021
Active Locations (23)
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1
Aurora, Colorado, United States, 80045
2
Pittsfield, Massachusetts, United States, 01201
3
Bruxelles - Brussel, Belgium, 1070
4
Bruxelles - Brussel, Belgium, 1090