Combination With Gemcitabine in Advanced Pancreatic Cancer
BAGPAC
A Multi-center, Phase I/II Study of BAY86-9766 in Combination With Gemcitabine in Patients With Locally Advanced Inoperable or Metastatic Pancreatic Cancer
2 other identifiers
interventional
90
9 countries
23
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2011
Typical duration for phase_1
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 8, 2010
CompletedFirst Posted
Study publicly available on registry
December 2, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 11, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedApril 8, 2021
April 1, 2021
2.1 years
November 8, 2010
April 6, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Subjects With Dose Limiting Toxicities (DLT): Phase I
From randomization up to the first 8 weeks of therapy
Tumor Response (Adjudicated Blinded Read Assessment): Phase II
From start of treatment until 134 weeks assessed every 8 weeks
Secondary Outcomes (11)
Tumor Response: Investigator Assessment: Phase I
From start of treatment until 134 weeks assessed every 8 weeks
Disease Control (DC): Phase I
From start of treatment until 134 weeks assessed every 8 weeks
Disease Control (DC): Phase II
From start of treatment until 134 weeks assessed every 8 weeks
Duration of Response (DOR): Phase I
From start of treatment until 134 weeks assessed every 8 weeks
Duration of Response: Phase II
From start of treatment until 134 weeks assessed every 8 weeks
- +6 more secondary outcomes
Study Arms (1)
Arm 1
EXPERIMENTALInterventions
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)
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (23)
Unknown Facility
Aurora, Colorado, 80045, United States
Unknown Facility
Pittsfield, Massachusetts, 01201, United States
Unknown Facility
Bruxelles - Brussel, 1070, Belgium
Unknown Facility
Bruxelles - Brussel, 1090, Belgium
Unknown Facility
Edegem, 2650, Belgium
Unknown Facility
Brno, 602 00, Czechia
Unknown Facility
Olomouc, 775 20, Czechia
Unknown Facility
Clermont-Ferrand, 63003, France
Unknown Facility
Heilbronn, Baden-Wurttemberg, 74078, Germany
Unknown Facility
München, Bavaria, 81377, Germany
Unknown Facility
Marburg, Hesse, 35033, Germany
Unknown Facility
Bochum, North Rhine-Westphalia, 44892, Germany
Unknown Facility
Berlin, 13353, Germany
Unknown Facility
Brescia, Lombardy, 25124, Italy
Unknown Facility
Ancona, The Marches, 60126, Italy
Unknown Facility
Oslo, 0310, Norway
Unknown Facility
Oslo, Norway
Unknown Facility
Bialystok, 15-027, Poland
Unknown Facility
Gdansk, 80-952, Poland
Unknown Facility
Warsaw, 02-781, Poland
Unknown Facility
London, SE1 9RT, United Kingdom
Unknown Facility
London, WC1E 6BT, United Kingdom
Unknown Facility
London, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 8, 2010
First Posted
December 2, 2010
Study Start
January 1, 2011
Primary Completion
February 11, 2013
Study Completion
August 1, 2013
Last Updated
April 8, 2021
Record last verified: 2021-04