Treatment of Patients Suffering From a Progressive Pancreas Carcinoma With Everolimus (RAD001) and Gemcitabine

Phase 1

Completed

• Conditions: Advanced or Metastatic Pancreatic Adenocarcinoma
• Interventions: Drug: everolimus

• Registration Number: NCT00560963
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

A dose finding study in locally advanced and/or metastatic pancreatic cancer patients

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-11-19
• Study First Submitted QC: 2007-11-19
• Study First Posted: 2007-11-20
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2012-11
• Last Update Submitted: 2020-12-17
• Last Update Posted: 2020-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1 RAD001	everolimus	-

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of everolimus in combination with Gemcitabine	8 weeks

Secondary Outcome Measures

Name	Time	Method
Safety & tolerability, pharmacokinetic assessments of Everolimus and Gemcitabine combination therapy in these patient populations. Phase II objective response rates (ORR), duration of response, progression-free survival (PFS), overall survival (OS)	36 weeks

Trial Locations

Locations (1)

Novartis Investigative Site; 🇩🇪 Ulm, Germany