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A Multicenter, Randomized, Blinded Efficacy and Safety Study of Pasireotide LAR vs Octreotide LAR in Patients With Metastatic Carcinoid Tumors Whose Disease-related Symptoms Are Inadequately Controlled by Somatostatin Analogues.


Phase 3
18 Years
N/A
Not Enrolling
Both
Symptomatic Refractory Resistant Carcinoid Disease

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Trial Information

A Multicenter, Randomized, Blinded Efficacy and Safety Study of Pasireotide LAR vs Octreotide LAR in Patients With Metastatic Carcinoid Tumors Whose Disease-related Symptoms Are Inadequately Controlled by Somatostatin Analogues.

Inclusion Criteria


Inclusion criteria:

- Male or female patients aged 18 or greater

- Patients with carcinoid tumors and symptoms (diarrhea and flushing) that are not
adequately controlled by somatostatin analogues.

- Female patients of child bearing potential must have a negative pregnancy test at
baseline.

- Patients for whom written informed consent to participate in the study has been
obtained.

Exclusion criteria:

- Patients receiving radiolabeled somatostatin analogue therapy within the 3 months or
any cytotoxic chemotherapy or interferon therapy within the 4 weeks prior to
randomization

- Diabetic patients on anti-diabetic medications whose fasting blood glucose is poorly
controlled as indicated by HBA1C > 8%

- Patients with symptomatic cholelithiasis

- Patient with malabsorption syndrome, short bowel or cholegenic diarrhea not
controlled by specific therapeutic means.

Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Efficacy assessed by Symptoms (Bowel Movements and/or Flushing)

Outcome Time Frame:

when all randomized patients have completed the core study

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CSOM230C2303

NCT ID:

NCT00690430

Start Date:

April 2008

Completion Date:

April 2012

Related Keywords:

  • Symptomatic Refractory Resistant Carcinoid Disease
  • Carcinoid
  • neuroendocrine
  • gastroenteropancreatic
  • somatostatin analogue
  • Symptomatic Refractory Resistant Carcinoid Disease
  • Carcinoid Tumor

Name

Location

Scottsdale Healthcare/TGen Clinical Research Service TGen Clinical Research ServiceScottsdale, Arizona  85258
Montefiore Medical Center MMCBronx, New York  10467
St. Luke's Hospital and Health Network St. Luke's Cancer NetworkBethlehem, Pennsylvania  
University of Arizona / Arizona Cancer CenterTucson, Arizona  85724
Loma Linda University Dept. of Loma Linda CancerCentLoma Linda, California  92354
Cedars Sinai Medical Center Cedars Sinai 4Los Angeles, California  90048
H. Lee Moffitt Cancer Center/University of South Florida Dept of H. Lee MoffitTampa, Florida  33612
Dana Farber Cancer Institute Gastrointestional Cancer UnitBoston, Massachusetts  02115
Duke University Medical Center Dept. of Duke Cancer Center(2)Durham, North Carolina  27710
MD Anderson Cancer Center/University of Texas Dept. of MD Anderson (9)Houston, Texas  77030-4009