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A Randomized, Double-blind, Multicenter, Phase III Study of Everolimus (RAD001) Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in the Treatment of Patients With Advanced NET of GI or Lung Origin


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Advanced NET of GI Origin, Advanced NET of Lung Origin, Neuroendocrine Tumors

Thank you

Trial Information

A Randomized, Double-blind, Multicenter, Phase III Study of Everolimus (RAD001) Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in the Treatment of Patients With Advanced NET of GI or Lung Origin


Inclusion Criteria:



- Pathologically confirmed, well differentiated (G1 or G2), advanced (unresectable or
metastatic), neuroendocrine tumor of GI or lung origin

- No history of and no active symptoms related to carcinoid syndrome

- In addition to treatment-naive patients, patients previously treated with SSA,
Interferon (IFN), one prior line of chemotherapy, and/or PRRT are allowed into the
study. Pretreated patients must have progressed on or after the last treatment

- Radiological documented disease progression within 6 months prior to randomization

- Measurable disease

- WHO performance status ≤1

- Adequate bone marrow, liver and renal function

Exclusion Criteria:

1. Patients with poorly differentiated neuroendocrine carcinoma, high-grade
neuroendocrine carcinoma, adenocarcinoid, pancreatic islet cell carcinoma,
insulinoma, glucagonoma, gastrinoma, goblet cell carcinoid, large cell neuroendocrine
carcinoma and small cell carcinoma

2. Patients with pancreatic NET or NET of origins other than GI or Lung

3. Patients with history of or active symptoms of carcinoid syndrome (e.g. flushing,
diarrhea)

4. Patients with more than one line of prior chemotherapy

5. Prior targeted therapy

6. Hepatic locoregional therapy within the last 6 months

7. Prior therapy with mTOR inhibitors (e.g. sirolimus, temsirolimus, deforolimus)

8. Known intolerance or hypersensitivity to everolimus or other rapamycin analogs (e.g.
sirolimus, temsirolimus)

9. Known impairment of gastrointestinal (GI) function or GI disease that may
significantly alter the absorption of oral everolimus

10. Uncontrolled diabetes mellitus as defined by HbA1c >8% despite adequate therapy

11. Patients who have any severe and/or uncontrolled medical conditions such as:

- unstable angina pectoris, symptomatic congestive heart failure, myocardial
infarction ≤6 months prior to randomization, serious uncontrolled cardiac
arrhythmia

- active or uncontrolled severe infection

- liver disease such as cirrhosis, decompensated liver disease, and chronic
hepatitis (i.e. quantifiable HBV-DNA and/or positive HbsAg, quantifiable
HCV-RNA)

12. Chronic treatment with corticosteroids or other immunosuppressive agents

13. Known history of HIV seropositivity

14. Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression free survival (PFS)

Outcome Description:

The estimated average duration from randomization date is at least 5-8.5 months until disease progression. PFS is defined as the time from randomization to the date of the first documented tumor progression as per modified RECIST 1.0 or death from any cause, whichever comes first. Progression is assessed by CT and/or MRI.

Outcome Time Frame:

From date of randomization to progression or death

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CRAD001T2302

NCT ID:

NCT01524783

Start Date:

March 2012

Completion Date:

January 2018

Related Keywords:

  • Advanced NET of GI Origin
  • Advanced NET of Lung Origin
  • Neuroendocrine Tumors
  • Neuroendocrine tumor
  • NET
  • progressive
  • advanced
  • gastrointestinal
  • GI or lung origin
  • nonfunctional
  • everolimus
  • Advanced NET of GI origin
  • Advanced NET of lung origin
  • Neuroendocrine Tumors

Name

Location

Georgetown University/Lombardi Cancer CenterWashington, District of Columbia  20007-2197
US Oncology Central MonitoringDallas, Texas  75246
University of South Alabama / Mitchell Cancer Institute Dept. of Mitchell Cancer Inst.Mobile, Alabama  36688
University of Iowa Hospitals & Clinics Univ Iowa 2Iowa City, Iowa  52242
Dana Farber Cancer Institute SCBoston, Massachusetts  02115
Washington Hospital Center Wash HospitalWashington, District of Columbia  20010
MD Anderson Cancer Center/University of Texas UT MD Anderson Cancer CtrHouston, Texas  77030-4009
Montefiore Medical Center MMCBronx, New York  10467
Memorial Sloan Kettering Cancer Center MSKCC SCNew York, New York  10021
Cedars Sinai Medical Center SCLos Angeles, California  90048
Mercy Medical Center Mercy Medical SCBaltimore, Maryland  21202
St. Luke's Hospital and Health Network St LukeBethlehem, Pennsylvania  
USC/Kenneth Norris Comprehensive Cancer Center USC/NorrisLos Angeles, California  90033
Scripps Clinic RegulatoryLa Jolla, California  92121
University of California San Diego RegulatoryLa Jolla, California  92093-0658
University of Colorado SCAurora, Colorado  80045
H. Lee Moffitt Cancer Center/University of South Florida HLMTampa, Florida  33612
University of Chicago Medical Center UC SCChicago, Illinois  60546
Indiana University Health Goshen Center for Cancer IU Health - SCIndianapolis, Indiana  46202
University of Kansas Cancer Center Univ KansasKansas City, Kansas  66160
Ochsner Clinic Foundation OchsnerNew Orleans, Louisiana  70121
University of Maryland Medical Center SCBaltimore, Maryland  21201
Massachusetts General Hospital Study CoordinatorBoston, Massachusetts  02114
Mayo Clinic - Rochester Dept. of Mayo Clinic (1)Rochester, Minnesota  55905
Research Medical Center CACZ885M2301Kansas City, Missouri  64132
University of Oklahoma Health Sciences Center SC -2Oklahoma City, Oklahoma  73104
Oregon Health & Science University OH&SUPortland, Oregon  97239
Penn State University / Milton S. Hershey Medical Center SCHershey, Pennsylvania  17033-0850
Fox Chase Cancer Center FCCC 2Philadelphia, Pennsylvania  19111-2497
Cancer Centers of the Carolinas SC - 2Greenville, South Carolina  29605
Vanderbilt University Medical Center Vanderbilt Med CtrNashville, Tennessee  37232
University of Texas Southwestern Medical Center UTSW 4Dallas, Texas  75390-8527
Texas Oncology, P.A. TX Onc BaylorDallas, Texas  75251
Texas Oncology, P.A. Texas Oncology - AmarilloDallas, Texas  75251
Scott and White Memorial Hospital Scott and WhiteTemple, Texas  76508-0002
University of Virginia Health Systems SC-3Charlottesville, Virginia  22908-0334
Eastern Virginia Medical School--Strelitz Diabetes InstituteNorfolk, Virginia  23510
University of Wisconsin / Paul P. Carbone Comp Cancer Center Univ WiscMadison, Wisconsin  53792-6164