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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Study Evaluating SOM230 in Patients With Metastatic Carcinoid Tumors

NCTNCT00088595 (opens ClinicalTrials.gov in a new tab)Other idCSOM230B2202
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
45 participants (actual)
Sponsor
Novartis Pharmaceuticals · Industry
Design
Not randomized · Open label (no masking)
Countries
1 country

United States

Start
Jan 2004
Primary completion
Jul 2008
Completion
Jul 2008
First posted
2 Aug 2004 (estimated)
Last update posted
4 Jun 2012 (estimated)
Conditions
Carcinoid Tumors

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200420052006200720082009
  1. Ph 2

    Study Evaluating SOM230 in Patients With Metastatic Carcinoid Tumors

    NCT00088595

    Jan 2004 to Jul 2008

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Study evaluating SOM230 in patients with metastatic carcinoid tumors

Interventions

  • Pasireotide (SOM230)Drug

Arms1

  • Experimental

    Pasireotide

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · 15 days

    Registry description

    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(4)

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

    Time frame · 15 days

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 15 days

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

GroupValue (participants)
Pasireotide (Any Dose)3
Secondary and other outcome results(4)
Secondary outcomeMean· 15 days

Duration of Complete Symptom Control (Days) by Dose Class

GroupValue (Days)Spread
Pasireotide 300 - ≤900 μgnot posted–
Pasireotide >900 - ≤1500 μg42.022.68
Pasireotide >1500 - ≤2400 μg47.0NA
Pasireotide Any Dose43.716.26
Secondary outcomeMean· up to 15 days

Duration of Partial Symptom Control (Days) by Dose Class

GroupValue (Days)Spread
Pasireotide 300-≤900 μgnot posted–
Pasireotide >900-≤1500 μg89.895.77
Pasireotide >1500-≤2400 μg36.328.73
Pasireotide Any Dose72.081.58
Secondary outcomeNumber· At least 15 days

The Number of Patients (Participants) With Overall Tumor Response

GroupValue (Participants)
Pasireotide (Any Dose)0
Secondary outcomeNumber· At least 15 days

The Overall Safety and Tolerability of Pasireotide

GroupValue (Participants)
Pasireotide (Any Dose)1

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Pasireotide 300 ≤ 900 μgPasireotide 300 ≤ 900 μg / day–3 / 4524 / 45
Pasireotide > 900 ≤ 1500 μgPasireotide \> 900 ≤ 1500 μg / day–3 / 4320 / 43
Pasireotide > 1500 ≤ 2400 μgPasireotide \> 1500 ≤ 2400 μg / day–10 / 3121 / 31

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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