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A Phase I, Multicenter, Open-label, Randomized Study Assessing the Pharmacokinetics, Safety, and Tolerability of Monthly Doses of Pasireotide i.m. LAR Injection in Patients With Acromegaly and Patients With Carcinoid Disease


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Carcinoid Tumor, Acromegaly

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Trial Information

A Phase I, Multicenter, Open-label, Randomized Study Assessing the Pharmacokinetics, Safety, and Tolerability of Monthly Doses of Pasireotide i.m. LAR Injection in Patients With Acromegaly and Patients With Carcinoid Disease

Inclusion Criteria


Inclusion criteria for patients with acromegaly:

- Male or female patients between 18 and 80 years

- Patients with acromegaly due to a pituitary adenoma with elevated GH and IGF-1
concentrations

Exclusion criteria for patients with acromegaly:

- Patients with compression of the optic chiasm causing any visual field defect

- Specific criteria apply for patients who have received certain types of therapies
such as radiotherapies, surgeries, chemo- or immunotherapies in the months prior to
study start

- Female patients who are pregnant or lactating

Inclusion criteria for patients with carcinoid disease:

- Male or female patients aged ≥18 years

- Patients with histologically confirmed, metastatic carcinoid tumors of the digestive
system

- Patients with elevation of chromogranin-A (CgA) and/or serotonin

- Patients who are not adequately controlled by somatostatin analogues

Exclusion criteria for patients with carcinoid disease:

- Specific criteria apply for patients who have received certain types of therapies
such as radiotherapies, surgeries, chemo- or immunotherapies in the months prior to
study start

- Female patients who are pregnant or lactating

Other protocol-defined in- and exclusion criteria may apply.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determination of the pharmacokinetic profile of single and monthly doses of pasireotide LAR i.m. injection

Outcome Description:

in patients with acromegaly and in patients with carcinoid disease

Outcome Time Frame:

Baseline, D7, D35, D63

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CSOM230C2110

NCT ID:

NCT00446082

Start Date:

June 2006

Completion Date:

January 2013

Related Keywords:

  • Carcinoid Tumor
  • Acromegaly
  • Refractory/ resistant carcinoid disease
  • acromegaly
  • adults
  • pasireotide LAR
  • somatostatin analogue
  • SOM230
  • pharmacokinetics
  • Refractory or resistant carcinoid disease and acromegaly
  • Acromegaly
  • Carcinoid Tumor

Name

Location

Stanford University Medical Center Stanford Cancer Center (3)Stanford, California  94304
Cedars Sinai Medical Center SC-3Los Angeles, California  90048
H. Lee Moffitt Cancer Center/University of South Florida Dept.of H.LeeMoffittCC&RI(1)Tampa, Florida  33612
MD Anderson Cancer Center/University of Texas Gastrointestinal Med. OncologyHouston, Texas  77030-4009