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Combination With Gemcitabine in Advanced Pancreatic Cancer (BAGPAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01251640
Recruitment Status : Completed
First Posted : December 2, 2010
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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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.


Condition or disease Intervention/treatment Phase
Pancreatic Neoplasms Drug: BAY86-9766+Gemcitabine Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center, Phase I/II Study of BAY86-9766 in Combination With Gemcitabine in Patients With Locally Advanced Inoperable or Metastatic Pancreatic Cancer
Actual Study Start Date : January 1, 2011
Actual Primary Completion Date : February 11, 2013
Actual Study Completion Date : August 1, 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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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)


Outcome Measures
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Primary Outcome Measures :
  1. Number of Subjects With Dose Limiting Toxicities (DLT): Phase I [ Time Frame: From randomization up to the first 8 weeks of therapy ]
  2. Tumor Response (Adjudicated Blinded Read Assessment): Phase II [ Time Frame: From start of treatment until 134 weeks assessed every 8 weeks ]

Secondary Outcome Measures :
  1. Tumor Response: Investigator Assessment: Phase I [ Time Frame: From start of treatment until 134 weeks assessed every 8 weeks ]
  2. Disease Control (DC): Phase I [ Time Frame: From start of treatment until 134 weeks assessed every 8 weeks ]
  3. Disease Control (DC): Phase II [ Time Frame: From start of treatment until 134 weeks assessed every 8 weeks ]
  4. Duration of Response (DOR): Phase I [ Time Frame: From start of treatment until 134 weeks assessed every 8 weeks ]
  5. Duration of Response: Phase II [ Time Frame: From start of treatment until 134 weeks assessed every 8 weeks ]
  6. Time to Progression (TTP): Phase I [ Time Frame: From start of treatment until 134 weeks assessed every 8 weeks ]
  7. Time to Progression (TTP): Phase II [ Time Frame: From start of treatment until 134 weeks assessed every 8 weeks ]
  8. Progression-Free Survival (PFS): Phase I [ Time Frame: From start of treatment until 134 weeks assessed every 8 weeks ]
  9. Progression-Free Survival (PFS): Phase II [ Time Frame: From start of treatment until 134 weeks assessed every 8 weeks ]
  10. Overall Survival (OS): Phase I [ Time Frame: From start of treatment until 134 weeks assessed every 8 weeks ]
  11. Overall Survival (OS): Phase II [ Time Frame: From start of treatment until 134 weeks assessed every 8 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01251640


Locations
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United States, Colorado
Aurora, Colorado, United States, 80045
United States, Massachusetts
Pittsfield, Massachusetts, United States, 01201
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
Heilbronn, Baden-Württemberg, Germany, 74078
München, Bayern, Germany, 81377
Marburg, Hessen, Germany, 35033
Bochum, Nordrhein-Westfalen, Germany, 44892
Berlin, Germany, 13353
Italy
Brescia, Lombardia, Italy, 25124
Ancona, Marche, Italy, 60126
Norway
Oslo, Norway, 0310
Oslo, Norway
Poland
Bialystok, Poland, 15-027
Gdansk, Poland, 80-952
Warszawa, Poland, 02-781
United Kingdom
London, United Kingdom, SE1 9RT
London, United Kingdom, WC1E 6BT
London, United Kingdom
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Additional Information:

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01251640    
Other Study ID Numbers: 14905
2010-019588-12 ( EudraCT Number )
First Posted: December 2, 2010    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021
Keywords provided by Bayer:
pancreatic cancer,
MEK-inhibitor
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs