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Completed

NCT Number: NCT00088595

Study Evaluating SOM230 in Patients With Metastatic Carcinoid Tumors

Study evaluating SOM230 in patients with metastatic carcinoid tumors

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Key information

Conditions

Carcinoid Tumors Adenocarcinoma Carcinoid Tumor Carcinoma Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Serotonin Syndrome

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cedars-Sinai Medical Center, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pasireotide (SOM230)

Drug

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 names: SOM230

Primary outcomes

  1. Symptom Control (Diarrhea/Flushing) Using a Patient Symptom Diary

    Time frame: 15 days

    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 outcomes

  1. Duration of Complete Symptom Control (Days) by Dose Class

    Time frame: 15 days

    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.

  2. Duration of Partial Symptom Control (Days) by Dose Class

    Time frame: up to 15 days

    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.

  3. The Number of Patients (Participants) With Overall Tumor Response

    Time frame: At least 15 days

    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.

  4. The Overall Safety and Tolerability of Pasireotide

    Time frame: At least 15 days

    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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Aug 2, 2004
Registry last updated
Jun 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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