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A Randomized Double-blind Phase III Study of RAD001 10 mg/d Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in the Treatment of Patients With Advanced Pancreatic Neuroendocrine Tumor (NET)


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Advanced Neuroendocrine Tumors

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Trial Information

A Randomized Double-blind Phase III Study of RAD001 10 mg/d Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in the Treatment of Patients With Advanced Pancreatic Neuroendocrine Tumor (NET)

Inclusion Criteria


Inclusion criteria:

1. Patients must have advanced (unresectable or metastatic) biopsy-proven pancreatic NET

2. Measurable disease by radiologic assessment

3. Adequate blood work

4. Performance Status 0-2 : Ability to be out of bed most of the time

5. Adult male or female patients ≥ 18 years of age

6. Women of childbearing potential must have a negative serum pregnancy test

7. Written informed consent from patients must be obtained in accordance to local
guidelines

Exclusion criteria:

1. Patients with severe kind of (poorly differentiated neuroendocrine carcinoma,
high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid and small
cell carcinoma) cancer are not eligible

2. Other chemotherapy, immunotherapy or radiotherapy within 4 weeks prior to starting
this trial

3. Hepatic artery procedure called embolization within the last 6 months (1 month if
there are other sites of measurable disease), or cryoablation/ radiofrequency
ablation of hepatic metastasis within 2 months of enrollment

4. Prior therapy with the same kind of medication (mTOR inhibitors: sirolimus,
temsirolimus, everolimus).

5. Uncontrolled diabetes mellitus Patients who have any severe and/or uncontrolled
medical conditions such as:

6. Patients receiving chronic treatment with corticosteroids or another
immunosuppressive agent

7. Patients with a known history of HIV seropositivity

8. No other prior or concurrent cancer at the time enrolling to this trial

Other protocol defined inclusion/ exclusion criteria applied

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Time to Progression Free Survival (PFS) Based as Per Investigator Using Kaplan-Meier Methodology

Outcome Description:

Progression of disease is defined as the time from study start to the date of first documented progression of disease or death due to any cause. Progression of disease is defined by RECIST criteria: Progression = 20% increase in the sum of the longest diameter of all target lesions, from the smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions.

Outcome Time Frame:

Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CRAD001C2324

NCT ID:

NCT00510068

Start Date:

July 2007

Completion Date:

December 2017

Related Keywords:

  • Advanced Neuroendocrine Tumors
  • Phase III
  • Advanced Neuroendocrine Tumor in adults
  • RAD001
  • NET
  • everolimus
  • mTOr
  • islet cell
  • neuroendocrine
  • Neuroendocrine Tumors

Name

Location

Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
The Center for Cancer and Blood DisordersFort Worth, Texas  76104
Mayo Clinic - RochesterRochester, Minnesota  55905
Pacific Cancer Medical Center, Inc.Anaheim, California  92801
Levine Cancer InstituteCharlotte, North Carolina  28211
Hematology Oncology Associates of Northern New Jersey PA Dept of Hem-Onc of Northern NJMorristown, New Jersey  07962
University of South Alabama / Mitchell Cancer Institute Deptof Mitchell Cancer Inst(2)Mobile, Alabama  36688
University of Louisville / James Graham Brown Cancer Center SCLouisville, Kentucky  40202
MD Anderson Cancer Center/University of Texas Dept of MD Anderson CancerCentHouston, Texas  77030-4009
Cedars Sinai Medical Center SC-2Los Angeles, California  90048
University of California at Los Angeles UCLA (3)Los Angeles, California  90095
University of California San Francisco Dept. of UCSF Comp. CancerSan Francisco, California  94143-0128
Kaiser Permanente Northwest Franklin Medical OfficesDenver, Colorado  
H. Lee Moffitt Cancer Center/University of South Florida Malignant Hematology ClinicTampa, Florida  33612
Indiana University Health Goshen Center for Cancer Dept. of Indiana Univ. CancerIndianapolis, Indiana  46202
University of Iowa Medical Center Dept. of Iowa Medical CenterIowa City, Iowa  52242
LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Dept. of Neuroendocrine ClinicNew Orleans, Louisiana  70115
Boston Medical Center BMCBoston, Massachusetts  02118
Wayne State University/Karmanos Cancer Institute Dept.of KarmanosCancerInst (4)Detroit, Michigan  48201
Littleton Regional Hospital Dept. of Hematology/OncologyLittleton, New Hampshire  03561
Columbia University Medical Center- New York Presbyterian Dept. of Columbia Med. CenterNew York, New York  10032
Ohio State Comprehensive Cancer Center/James Cancer Hospital Dept. of OHSU Medical CenterColumbus, Ohio  43210
Oregon Health & Science University Dept. of OHSU (3)Portland, Oregon  97239
St. Luke's Hospital and Health Network St. Luke's Cancer NetworkBethlehem, Pennsylvania  
University of Pittsburgh Medical Center Hillman Cancer CenterPittsburgh, Pennsylvania