Combination With Gemcitabine in Advanced Pancreatic Cancer

Pancreatic Neoplasms Clinical Trial

— BAGPAC  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01251640
• Other study ID #: 14905
• Secondary ID: 2010-019588-12
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 1, 2011
• Est. completion date: August 1, 2013

Study information

• Verified date: April 2021
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 1, 2013
• Est. primary completion date: February 11, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Neoplasms

Intervention

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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Belgium,  Czechia,  France,  Germany,  Italy,  Norway,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With Dose Limiting Toxicities (DLT): Phase I		From randomization up to the first 8 weeks of therapy
Primary	Tumor Response (Adjudicated Blinded Read Assessment): Phase II		From start of treatment until 134 weeks assessed every 8 weeks
Secondary	Tumor Response: Investigator Assessment: Phase I		From start of treatment until 134 weeks assessed every 8 weeks
Secondary	Disease Control (DC): Phase I		From start of treatment until 134 weeks assessed every 8 weeks
Secondary	Disease Control (DC): Phase II		From start of treatment until 134 weeks assessed every 8 weeks
Secondary	Duration of Response (DOR): Phase I		From start of treatment until 134 weeks assessed every 8 weeks
Secondary	Duration of Response: Phase II		From start of treatment until 134 weeks assessed every 8 weeks
Secondary	Time to Progression (TTP): Phase I		From start of treatment until 134 weeks assessed every 8 weeks
Secondary	Time to Progression (TTP): Phase II		From start of treatment until 134 weeks assessed every 8 weeks
Secondary	Progression-Free Survival (PFS): Phase I		From start of treatment until 134 weeks assessed every 8 weeks
Secondary	Progression-Free Survival (PFS): Phase II		From start of treatment until 134 weeks assessed every 8 weeks
Secondary	Overall Survival (OS): Phase I		From start of treatment until 134 weeks assessed every 8 weeks
Secondary	Overall Survival (OS): Phase II		From start of treatment until 134 weeks assessed every 8 weeks

External Links

•   Click here to find information about studies related to Bayer Healthcare products conducted in Europe
•   Click here to find results for studies related to Bayer Healthcare products.