Clinical trial NCT00088595: Study Evaluating SOM230 in Patients With Metastatic Carcinoid Tumors
Official title: An Open-label, Multicenter, Phase II Study Evaluating the Safety and Efficacy of Twice Daily Dosing of SOM230 in Patients With Metastatic Carcinoid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoid Tumors
Keywords: SOM230
Sandostatin
Carcinoid syndrome
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2004-08-02
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study evaluating SOM230 in patients with metastatic carcinoid tumors


Eligibility criteria: Inclusion Criteria:

* Patients with biopsy-proven metastatic carcinoid tumors
* Patients with at least one measurable lesion (excluding bone)
* Patients must be considered inadequately controlled while on Sandostatin LAR therapy based on the symptoms of carcinoid syndrome (diarrhea and/or flushing) as defined as experiencing a minimum average of at least four bowel movements per day or a minimum average of at least two episodes of flushing per day

Exclusion Criteria:

* Patients who have been previously treated with certain medications may be required to be without certain medications prior to entering the study
* Patients who have undergone major recent surgery / surgical therapy for any cause within 1 month
* Patients on any cytotoxic chemotherapy or interferon therapy within the last 2 months
* Patients with uncontrolled diabetes mellitus
* Patients who had received radiotherapy for any reason within the last 4 weeks must have recovered from any side effects of radiotherapy
* Patients who have congestive heart failure unstable angina, cardiac arrhythmia or a history of acute myocardial infarction within the three months preceding enrollment
* Patients with chronic liver disease
* Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method for birth control.
* History of immunocompromise, including a positive HIV test result
* Patients who have a history of alcohol or drug abuse in the 6 month period prior to receiving SOM230
* Patients who have given a blood donation (of 400 mL or more) within 2 months before receiving SOM230
* Patients who have participated in any clinical investigation with an investigational drug within 1 month prior to dosing
* Patients with additional active malignant disease within the last five years

Primary outcomes:
measure: Symptom Control (Diarrhea/Flushing) Using a Patient Symptom Diary
timeFrame: 15 days
Secondary outcomes:
measure: Duration of Complete Symptom Control (Days) by Dose Class
timeFrame: 15 days
measure: Duration of Partial Symptom Control (Days) by Dose Class
timeFrame: up to 15 days
measure: The Number of Patients (Participants) With Overall Tumor Response
timeFrame: At least 15 days
measure: The Overall Safety and Tolerability of Pasireotide
timeFrame: At least 15 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
city: Iowa City
country: United States
facility: Univ. Of Iowa Holden Cancer Center
state: Iowa
city: New Orleans
country: United States
facility: Louisiana State University Medical Center
state: Louisiana
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: