A Phase 1/2 interventional study of BAY86-9766+Gemcitabine in Pancreatic Neoplasms, sponsored by Bayer. Completed at 23 sites in 9 countries. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2021-04-08.
Sponsored by Bayer · Phase 1/2, Interventional, and Treatment
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.
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 898 are open to participants now.
This study's enrollment of 90 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: BAY86-9766+Gemcitabine
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)
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
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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