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NCT00446082·Phase 1·INTERVENTIONAL

Study of Pasireotide Long Acting Release (LAR) Injection in Patients With Acromegaly and Patients With Carcinoid Disease

Status

Completed

Phase

Phase 1

Enrollment

85

Locations

17

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

This study will assess the pharmacokinetic profile and the safety/tolerability profile of single and monthly doses of pasireotide LAR intramuscular (i.m.) injection in patients with acromegaly and patients with carcinoid disease

Interventions

Treatment arms and agents.

DRUG

Pasireotide

Timeline

From registration to results.

  1. First posted

    Mar 12, 2007

  2. Study start

    Jun 2006

  3. Primary completion

    Nov 2013

  4. Study completion

    Nov 2013

  5. Results posted

    Not reported

  6. Registry updated

    Dec 21, 2020

Outcomes

What the study measures.

Primary outcomes

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

Time frame · Baseline, D7, D35, D63

in patients with acromegaly and in patients with carcinoid disease

Secondary outcomes

To explore the pharmacodynamic profile of single and monthly doses of pasireotide LAR i.m. injection

Time frame · Baseline, D7, D35, D63

in patients with acromegaly and in patients with carcinoid disease.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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.

Study locations

17 registered sites.

Belgium · Canada · Germany · Netherlands · Norway · United States. Showing up to 24 locations stored in the fast local snapshot.

Cedars Sinai Medical Center SC - 4

Los Angeles, California, United States

Stanford University Medical Center Stanford Cancer Center (3)

Stanford, California, United States

H. Lee Moffitt Cancer Center & Research Institute Dept.of H.LeeMoffittCC&RI(1)

Tampa, Florida, United States

University of Texas/MD Anderson Cancer Center Gastrointestinal Med. Oncology

Houston, Texas, United States

Novartis Investigative Site

Brussels, Belgium

Novartis Investigative Site

Leuven, Belgium

Novartis Investigative Site

Liège, Belgium

Novartis Investigative Site

London, Ontario, Canada

Novartis Investigative Site

Toronto, Ontario, Canada

Novartis Investigative Site

Montreal, Quebec, Canada

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Essen, Germany

Novartis Investigative Site

Leipzig, Germany

Novartis Investigative Site

München, Germany

Novartis Investigative Site

Rotterdam, Netherlands

Novartis Investigative Site

Oslo, Norway

Related trials

More studies on Pasireotide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.