Combination With Gemcitabine in Advanced Pancreatic Cancer

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Gemcitabine

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