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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Phase I: 40 mg/day (20 mg twice daily), 60 mg/day (30 mg twice daily, 100 mg/day (50 mg bid) dependent on safety/tolerability Phase II: Recommended Phase II dose (RP2D) dependent on the results of the Phase I part of this study Route of administration: Oral, twice daily (bid) in combination with gemcitabine 1000 mg/m2 Intravenous infusion over 30 minutes weekly for seven out of eight weeks (Cycle 1); followed by 1000 mg/m2 Intravenous infusion over 30 minutes weekly for three out of four weeks (Cycle 2 and subsequent)
Unnamed facility
Aurora, Colorado, United States
Unnamed facility
Pittsfield, Massachusetts, United States
Unnamed facility
Bruxelles - Brussel, Belgium
Unnamed facility
Bruxelles - Brussel, Belgium
Unnamed facility
Edegem, Belgium
Unnamed facility
Brno, Czechia
Unnamed facility
Olomouc, Czechia
Unnamed facility
Clermont-Ferrand, France
Unnamed facility
Heilbronn, Baden-Wurttemberg, Germany
Unnamed facility
München, Bavaria, Germany
...and 13 more locations
Number of Subjects With Dose Limiting Toxicities (DLT): Phase I
Time frame: From randomization up to the first 8 weeks of therapy
Tumor Response (Adjudicated Blinded Read Assessment): Phase II
Time frame: From start of treatment until 134 weeks assessed every 8 weeks
Tumor Response: Investigator Assessment: Phase I
Time frame: From start of treatment until 134 weeks assessed every 8 weeks
Disease Control (DC): Phase I
Time frame: From start of treatment until 134 weeks assessed every 8 weeks
Disease Control (DC): Phase II
Time frame: From start of treatment until 134 weeks assessed every 8 weeks
Duration of Response (DOR): Phase I
Time frame: From start of treatment until 134 weeks assessed every 8 weeks
Duration of Response: Phase II
Time frame: From start of treatment until 134 weeks assessed every 8 weeks
Time to Progression (TTP): Phase I
Time frame: From start of treatment until 134 weeks assessed every 8 weeks
Time to Progression (TTP): Phase II
Time frame: From start of treatment until 134 weeks assessed every 8 weeks
Progression-Free Survival (PFS): Phase I
Time frame: From start of treatment until 134 weeks assessed every 8 weeks
Progression-Free Survival (PFS): Phase II
Time frame: From start of treatment until 134 weeks assessed every 8 weeks
Overall Survival (OS): Phase I
Time frame: From start of treatment until 134 weeks assessed every 8 weeks
Overall Survival (OS): Phase II
Time frame: From start of treatment until 134 weeks assessed every 8 weeks
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