RAD001 In Previously Treated Patients With Metastatic Pancreatic Cancer

Study Overview

RAD001 in Previously Treated Patients With Metastatic Pancreatic Cancer

The purpose of this research study is to investigate if RAD001 is an effective treatment for pancreatic cancer that has spread and not responded to treatment. Experiments have shown that RAD001 can prevent cells from multiplying. RAD002 has also been tested in laboratory experiments imitating cancer conditions and the results have been promising.

* Participants taking part in this research study will be given a study medication-dosing calendar for each treatment cycle. Each cycle lasts four weeks during which you will be taking the study drug, RAD001, orally every day. * Participants will come into the clinic every other week during the time of enrollment. At each clinic visit blood work will be taken to monitor the participants health and a physical exam will be performed. CT scans will be repeated every 2 months to assess the tumor. * Participants will remain on the study as long as they continue to benefit from the study medication.

Pancreatic Cancer

DRUG: RAD001

06-197

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
First Submitted 2006-12-06	Results First Submitted 2014-04-30	Last Update Submitted that met QC Criteria 2014-07-23
First Submitted that Met QC Criteria 2006-12-06	Results First Submitted that Met QC Criteria 2014-07-23	Last Update Posted (ESTIMATED) 2014-08-11
First Posted (ESTIMATED) 2006-12-08	Results First Posted 2014-08-11	Last Verified 2014-07

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:
Non Randomized

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: RAD001 RAD001 was administered continuously at a dose of 10 mg daily by mouth until disease progression, unacceptable toxicity, or withdrawal of consent. Four weeks of study drug was considered to be one cycle of treatment.	DRUG: RAD001 Taken orally daily for as long as the participant continues to receive a benefit.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: RAD001

RAD001 was administered continuously at a dose of 10 mg daily by mouth until disease progression, unacceptable toxicity, or withdrawal of consent. Four weeks of study drug was considered to be one cycle of treatment.

DRUG: RAD001

Taken orally daily for as long as the participant continues to receive a benefit.

Primary Outcome Measures	Measure Description	Time Frame
To Assess Progression-free Survival of RAD001 at Two Months in Patients With Metastatic Pancreatic Cancer Whose Disease Has Progressed on Gemcitabine Chemotherapy.	The Outcome Measure is reporting the number of participants experiencing Progression-free Survival at 2 months after treatment. The study was designed with a primary end point of progression-free survival (PFS), defined as the time from study entry to documentation of progressive disease or death from any cause. On the basis of prior studies of second-line treatment in metastatic pancreatic cancer, we estimated that such treatment has been associated with a median PFS of 2 months. Our study design used a one-stage design with a target accrual of 35 eligible patients, with the assumption that an improvement in PFS at 2 months from 50% to 71% would warrant further study in this patient population.	two months

Secondary Outcome Measures	Measure Description	Time Frame
To Assess the Safety of RAD001 in Patients With Metastatic Pancreatic Cancer	Patients were followed for the duration of their time on treatment and 30 days after their last dose of RAD001. The number of patients with treatment-related adverse events are reported.	Patients were followed for the duration of their time on treatment and 30 days after their last dose of RAD001.
to Assess Response Rate Associated With RAD001 in This Patient Population.	The secondary objectives of the study were to assess tumor response rate and overall survival. Patients were required to have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST). Per RECIST, for target lesions assessed by CT: Complete Response (CR) is Disappearance of all target lesions; Partial Response (PR) is >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) equals CR + PR.	2 years
to Assess Overall Survival Associated With RAD001 in This Patient Population.	Overall survival was defined as the time from study entry until death from any cause.	2 years

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:

Pathologic confirmation of pancreatic adenocarcinoma
18 years of age or older
At least one measurable site of disease according to RECIST criteria that has not been previously irradiated. If patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation.
Treated with gemcitabine-based chemotherapy with documented tumor progression on gemcitabine or intolerance to gemcitabine.
Prior treatment with no more than 1 prior chemotherapy regimen for metastatic disease.
Minimum of two weeks since any major surgery, completion of radiation, or completion of all prior systemic anti-cancer therapy.
ECOG performance status 0-1.
Life expectancy of greater than 12 weeks.
Adequate bone marrow and liver function.
Must be able to swallow tablets.

Prior treatment with an investigational drug within the preceding 4 weeks.
Prior treatment with an inhibitor of mTOR
Chronic treatment with systemic steroids or another immunosuppressive agent
More than one prior chemotherapy treatment for metastatic disease
Uncontrolled brain or leptomeningeal metastases, including patient who continue to require glucocorticoids for brain or leptomeningeal metastases.
Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin
Patients with chronic renal insufficiency
Other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study.
Known history of HIV seropositivity
Impairment of gastrointestinal function or gastrointestinal disease that my significantly alter the absorption of RAD001.
Active, bleeding diathesis or an oral vitamin K antagonist medication
Women who are pregnant or breast feeding

Collaborators and Investigators

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

Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Novartis

Investigators

PRINCIPAL_INVESTIGATOR: Charles Fuchs, MD, Dana-Farber Cancer Institute

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

Wolpin BM, Hezel AF, Abrams T, Blaszkowsky LS, Meyerhardt JA, Chan JA, Enzinger PC, Allen B, Clark JW, Ryan DP, Fuchs CS. Oral mTOR inhibitor everolimus in patients with gemcitabine-refractory metastatic pancreatic cancer. J Clin Oncol. 2009 Jan 10;27(2):193-8. doi: 10.1200/JCO.2008.18.9514. Epub 2008 Dec 1.

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Clinical Trial Record