Combination With Gemcitabine in Advanced Pancreatic Cancer (BAGPAC)

April 6, 2021 updated by: Bayer

A Multi-center, Phase I/II Study of BAY86-9766 in Combination With Gemcitabine in Patients With Locally Advanced Inoperable or Metastatic Pancreatic Cancer

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles - Brussel, Belgium, 1070
      • Bruxelles - Brussel, Belgium, 1090
      • Edegem, Belgium, 2650
  • Czechia
      • Brno, Czechia, 602 00
      • Olomouc, Czechia, 775 20
  • France
      • CLERMONT-FERRAND Cedex 1, France, 63003
  • Germany
      • Berlin, Germany, 13353
    • Baden-Württemberg
      • Heilbronn, Baden-Württemberg, Germany, 74078
    • Bayern
      • München, Bayern, Germany, 81377
    • Hessen
      • Marburg, Hessen, Germany, 35033
    • Nordrhein-Westfalen
      • Bochum, Nordrhein-Westfalen, Germany, 44892
  • Italy
    • Lombardia
      • Brescia, Lombardia, Italy, 25124
    • Marche
      • Ancona, Marche, Italy, 60126
  • Norway
      • Oslo, Norway
      • Oslo, Norway, 0310
  • Poland
      • Bialystok, Poland, 15-027
      • Gdansk, Poland, 80-952
      • Warszawa, Poland, 02-781
  • United Kingdom
      • London, United Kingdom
      • London, United Kingdom, SE1 9RT
      • London, United Kingdom, WC1E 6BT
  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
    • Massachusetts
      • Pittsfield, Massachusetts, United States, 01201

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Subjects With Dose Limiting Toxicities (DLT): Phase I
Time Frame: From randomization up to the first 8 weeks of therapy
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
From start of treatment until 134 weeks assessed every 8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Tumor Response: Investigator Assessment: Phase I
Time Frame: From start of treatment until 134 weeks assessed every 8 weeks
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
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
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
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
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
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
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
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
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
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
From start of treatment until 134 weeks assessed every 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2011

Primary Completion (Actual)

February 11, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

November 8, 2010

First Submitted That Met QC Criteria

December 1, 2010

First Posted (Estimate)

December 2, 2010

Study Record Updates

Last Update Posted (Actual)

April 8, 2021

Last Update Submitted That Met QC Criteria

April 6, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14905
  • 2010-019588-12 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pancreatic Neoplasms

Clinical Trials on BAY86-9766+Gemcitabine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Albania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe