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Clinical Trial Record

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

2007-10

2011-01

2011-01

21

Study Overview

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

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

N/A

  • Advanced or Metastatic Pancreatic Adenocarcinoma
  • DRUG: everolimus
  • CRAD001C2491

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2007-11-19  

N/A  

2020-12-17  

2007-11-19  

N/A  

2020-12-21  

2007-11-20  

N/A  

2012-11  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: 1 RAD001

DRUG: everolimus

Primary Outcome MeasuresMeasure DescriptionTime Frame
Maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of everolimus in combination with Gemcitabine8 weeks
Secondary Outcome MeasuresMeasure DescriptionTime Frame
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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion criteria:
    1. Histologically confirmed locally advanced, irresectable pancreatic adenocarcinoma (head, corpus, tail) with or without distant metastases 2. Adequate bone marrow, liver and renal function on everolimus treatment 3. At least one measurable lesion according to RECIST criteria that has not been previously irradiated. 4. Patients must be at least 4 weeks since prior major surgery and recovered, at least 2 weeks and recovered since prior minor surgery, completion of radiation, or completion of all prior systemic anticancer. 5. Age >18 years
    Exclusion criteria:
    1. Women who are pregnant or breast feeding. 2. Documented intolerance or history of allergy to everolimus or Gemcitabine. 3. History of another malignancy within 5 years prior to study entry, except curatively treated non-melanotic skin cancer or in-situ cervical cancer 4. Known or symptomatic central nervous system (CNS) metastases or leptomeningeal involvement 5. Chronic treatment with systemic steroids or another immunosuppressive agent 6. Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus 7. Patients with an active, bleeding diathesis or on oral anti-vitamin K medication (except low dose coumarin). Quick-value < 50 % or prothrombine time more than 1,5 fold higher
    Other protocol defined inclusion/exclusion criteria may apply

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

    • STUDY_DIRECTOR: Novartis Pharmaceuticals, Novartis Pharmaceuticals

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available

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