Combination With Gemcitabine in Advanced Pancreatic Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 13 May 2013
• Main ID: NCT01251640
• Date of registration: 08/11/2010
• Primary sponsor: Bayer
• Public title: Combination With Gemcitabine in Advanced Pancreatic Cancer BAGPAC
• Scientific 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
• Date of first enrolment: January 2011
• Target sample size: 90
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01251640
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Belgium, Czech Republic, France, Germany, Italy, Norway, Poland, United Kingdom, United States

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion 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
- Eastern Cooperative Oncology Group performance status (ECOG PS)
- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Pancreatic Neoplasms

Intervention(s)

Drug: BAY86-9766+Gemcitabine

Primary Outcome(s)

Determine the efficacy of the combination BAY86-9766 / gemcitabine in terms of the best overall response rate (confirmed complete response + partial response) according to RECIST Version 1.1 [Time Frame: 3 months after Last Patient First Treatment]

Determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) of BAY86-9766 to be investigated in combination with the standard gemcitabine regimen in the subsequent Phase II part of this study [Time Frame: 6 months after Last Patient First Treatment]

Secondary Outcome(s)

Assess biomarkers [Time Frame: 8 months after Last Patient First Treatment]

Assess pharmacokinetics (PK) of gemcitabine and BAY86-9766; if needed, PK assessments may also [Time Frame: 22 days after Last Patient First Treatment]

Determine patient reported outcome (pain evaluation) [Time Frame: 8 months after Last Patient First Treatment]

Disease control rate (DCR) [Time Frame: 8 months after Last Patient First Treatment]

Investigate the safety and tolerability and efficacy of up to three dose levels of BAY86-9766 in combination with the standard gemcitabine regimen [Time Frame: 8 months after Last Patient First Treatment]

Overall survival (OS) [Time Frame: 8 months after Last Patient First Treatment]

Progression-free survival (PFS) [Time Frame: 8 months after Last Patient First Treatment]

Response duration (DOR) [Time Frame: 8 months after Last Patient First Treatment]

Time to progression (TTP) [Time Frame: 8 months after Last Patient First Treatment]

Secondary ID(s)

14905

2010-019588-12

Source(s) of Monetary Support

Please refer to primary and secondary sponsors