Combination With Gemcitabine in Advanced Pancreatic Cancer

Completed · Phase 1/Phase 2

Conditions studied: Pancreatic Neoplasms

In brief

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.

Key facts

Study ID

NCT01251640

Run by

Bayer

People needed

90

Starts

2011-01-01

Expected to finish

2013-08-01

Last updated by the study team

2021-04-08

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Aurora, Colorado, United States
• Study site — Pittsfield, Massachusetts, United States
• Study site — Bruxelles - Brussel, Belgium
• Study site — Bruxelles - Brussel, Belgium
• Study site — Edegem, Belgium
• Study site — Brno, Czechia
• Study site — Olomouc, Czechia
• Study site — Clermont-Ferrand, France
• Study site — Heilbronn, Baden-Wurttemberg, Germany
• Study site — München, Bavaria, Germany
• Study site — Marburg, Hesse, Germany
• Study site — Bochum, North Rhine-Westphalia, Germany
• Study site — Berlin, Germany
• Study site — Brescia, Lombardy, Italy
• Study site — Ancona, The Marches, Italy
• Study site — Oslo, Norway
• Study site — Oslo, Norway
• Study site — Bialystok, Poland
• Study site — Gdansk, Poland
• Study site — Warsaw, Poland
• Study site — London, United Kingdom
• Study site — London, United Kingdom
• Study site — London, United Kingdom

Full record on ClinicalTrials.gov

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