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RAD001 in Previously Treated Patients With Metastatic Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00409292
Recruitment Status : Completed
First Posted : December 8, 2006
Results First Posted : August 11, 2014
Last Update Posted : August 11, 2014
Sponsor:
Collaborators:
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Novartis
Information provided by (Responsible Party):
Brian Wolpin, MD, MPH, Dana-Farber Cancer Institute

Tracking Information
First Submitted Date  ICMJE December 6, 2006
First Posted Date  ICMJE December 8, 2006
Results First Submitted Date  ICMJE April 30, 2014
Results First Posted Date  ICMJE August 11, 2014
Last Update Posted Date August 11, 2014
Study Start Date  ICMJE January 2007
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2014)
To Assess Progression-free Survival of RAD001 at Two Months in Patients With Metastatic Pancreatic Cancer Whose Disease Has Progressed on Gemcitabine Chemotherapy. [ Time Frame: two months ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 6, 2006)
To Assess Progression-free Survival of RAD001 at Two Months in Patients With Metastatic Pancreatic Cancer Whose Disease Has Progressed on Gemcitabine Chemotherapy.
Change History Complete list of historical versions of study NCT00409292 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2014)
  • To Assess the Safety of RAD001 in Patients With Metastatic Pancreatic Cancer [ Time Frame: Patients were followed for the duration of their time on treatment and 30 days after their last dose of RAD001. ]
    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.
  • to Assess Response Rate Associated With RAD001 in This Patient Population. [ Time Frame: 2 years ]
    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.
  • to Assess Overall Survival Associated With RAD001 in This Patient Population. [ Time Frame: 2 years ]
    Overall survival was defined as the time from study entry until death from any cause.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 6, 2006)
  • To Assess the Safety of RAD001 in Patients With Metastatic Pancreatic Cancer
  • to assess response rate and overall survival associated with RAD001 in this patient population.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE RAD001 in Previously Treated Patients With Metastatic Pancreatic Cancer
Official Title  ICMJE Phase II Study of RAD001 in Previously Treated Patients With Metastatic Pancreatic Cancer
Brief Summary 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.
Detailed Description
  • 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Cancer
Intervention  ICMJE Drug: RAD001
Taken orally daily for as long as the participant continues to receive a benefit.
Study Arms  ICMJE 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.

Intervention: Drug: RAD001
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 23, 2014)
33
Original Enrollment  ICMJE
 (submitted: December 6, 2006)
35
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00409292
Other Study ID Numbers  ICMJE 06-197
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Brian Wolpin, MD, MPH, Dana-Farber Cancer Institute
Study Sponsor  ICMJE Dana-Farber Cancer Institute
Collaborators  ICMJE
  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
  • Novartis
Investigators  ICMJE
Principal Investigator: Charles Fuchs, MD Dana-Farber Cancer Institute
PRS Account Dana-Farber Cancer Institute
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP