Combination With Gemcitabine in Advanced Pancreatic Cancer
- Conditions
- Pancreatic Neoplasms
- Interventions
- Drug: BAY86-9766+Gemcitabine
- Registration Number
- NCT01251640
- Lead Sponsor
- Bayer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1 BAY86-9766+Gemcitabine -
- Primary Outcome Measures
Name Time Method Number of Subjects With Dose Limiting Toxicities (DLT): Phase I From randomization up to the first 8 weeks of therapy Tumor Response (Adjudicated Blinded Read Assessment): Phase II From start of treatment until 134 weeks assessed every 8 weeks
- Secondary Outcome Measures
Name Time Method Disease Control (DC): Phase II From start of treatment until 134 weeks assessed every 8 weeks Time to Progression (TTP): Phase II From start of treatment until 134 weeks assessed every 8 weeks Tumor Response: Investigator Assessment: Phase I From start of treatment until 134 weeks assessed every 8 weeks Disease Control (DC): Phase I From start of treatment until 134 weeks assessed every 8 weeks Duration of Response (DOR): Phase I From start of treatment until 134 weeks assessed every 8 weeks Duration of Response: Phase II From start of treatment until 134 weeks assessed every 8 weeks Time to Progression (TTP): Phase I From start of treatment until 134 weeks assessed every 8 weeks Progression-Free Survival (PFS): Phase I From start of treatment until 134 weeks assessed every 8 weeks Progression-Free Survival (PFS): Phase II From start of treatment until 134 weeks assessed every 8 weeks Overall Survival (OS): Phase I From start of treatment until 134 weeks assessed every 8 weeks Overall Survival (OS): Phase II From start of treatment until 134 weeks assessed every 8 weeks