Study Evaluating SOM230 in Patients With Metastatic Carcinoid Tumors - Full Text View

Purpose

Study evaluating SOM230 in patients with metastatic carcinoid tumors

Condition	Intervention	Phase
Carcinoid Tumors	Drug: Pasireotide (SOM230)	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Carcinoid Tumors

Drug Information available for: Pasireotide

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Symptom Control (Diarrhea/Flushing) Using a Patient Symptom Diary [ Time Frame: 15 days ] [ Designated as safety issue: No ]
Complete Symptom Control: an average of ≤ 3 bowel movements per day for at least 15 consecutive days, with no more than 3 episodes on any given day, and no episodes of flushing over the time interval being studied.

Partial Symptom Control: an average of < 4 bowel movements per day for at least 15 consecutive days, with no more than 6 episodes per given day, and an average of fewer than 2 daily flushing episodes over the same given time interval.

Treatment failure: Failure to obtain partial or complete treatment success over a consecutive 15-day period at a constant dose level.

Secondary Outcome Measures:

Duration of Complete Symptom Control (Days) by Dose Class [ Time Frame: 15 days ] [ Designated as safety issue: No ]
Complete symptom control: an average of three or less bowel movements per day for at least 15 consecutive days, with no more than three episodes on any given day, and no episodes of flushing over the time interval being studied.
Duration of Partial Symptom Control (Days) by Dose Class [ Time Frame: up to 15 days ] [ Designated as safety issue: No ]
Partial symptom control: an average of less than four bowel movements per day for at least 15 consecutive days, with no more than six episodes per any given day, and an average of less than two daily flushing episodes over the same given time interval.
The Number of Patients (Participants) With Overall Tumor Response [ Time Frame: At least 15 days ] [ Designated as safety issue: No ]
The disappearance of all lesions was considered a complete response and at least a 30% decrease in the diameter of lesions was considered a partial response (PR). Progressive disease (PD) required a 20% increase in the sum of the diameters of lesions and changes that did not qualify for PR or PD were considered stable disease. Progression not documented was defined as unknown. No more than a 10% increase in biochemical values, and no clinical signs of DP with complete or adequate control over symptoms were defined as complete treatment success and partial treatment success, respectively.
The Overall Safety and Tolerability of Pasireotide [ Time Frame: At least 15 days ] [ Designated as safety issue: Yes ]
Safety assessments consisted of recording all AEs and serious adverse events (SAEs), the regular monitoring of hematology, blood chemistry, vital signs, physical condition and body weight.

Enrollment:	45
Study Start Date:	January 2004
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Pasireotide	Drug: Pasireotide (SOM230) Open label. Patients received starting dose of 300 µg of study drug subcutaneously (s.c.) twice (total of 600 µg ) daily for three days, which could be increased in 150 µg increments up to 900 µg twice daily (total 1800 µg daily) if control of symptoms was not achieved. Prior sponsor agreement was required for a higher dose. A dose of 2400 µg/day was the maximum allowed. Dose reductions of 300 µg/day were allowed at any time if unacceptable toxicity occurred. Other Name: SOM230

Arms

Assigned Interventions

Experimental: Pasireotide

Drug: Pasireotide (SOM230)

Open label. Patients received starting dose of 300 µg of study drug subcutaneously (s.c.) twice (total of 600 µg ) daily for three days, which could be increased in 150 µg increments up to 900 µg twice daily (total 1800 µg daily) if control of symptoms was not achieved. Prior sponsor agreement was required for a higher dose. A dose of 2400 µg/day was the maximum allowed. Dose reductions of 300 µg/day were allowed at any time if unacceptable toxicity occurred.

Other Name: SOM230

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00088595

Locations

United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
United States, Iowa
Univ. Of Iowa Holden Cancer Center
Iowa City, Iowa, United States, 52242
United States, Louisiana
Louisiana State University Medical Center
New Orleans, Louisiana, United States, 70112

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT00088595 History of Changes
Other Study ID Numbers:	CSOM230B2202
Study First Received:	July 30, 2004
Results First Received:	January 21, 2011
Last Updated:	May 29, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

SOM230
Sandostatin
Carcinoid syndrome

Additional relevant MeSH terms:

Carcinoid Tumor
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type

Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on May 16, 2013