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Placebo-controlled prospective randomized phase III study to investigate the antiproliferative effect of octreotide in patients with metastasized neuroendocrine tumors of the midgut
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Octreotide LAR (Long Acting Release) | Experimental | Octreotide LAR 30 mg intramuscularly every 28 days |
|
| Placebo | Placebo Comparator | Placebo - Sodium chloride intramuscularly every 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Octreotide LAR (Long-acting release) | Drug | 30 mg intramuscularly every 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Tumor Progression Documented by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) | Median time to tumor progression at the time of the planned interim analysis that includes all data observed until June 2008. | Up to 7 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rates According to World Health Organization (WHO) Criteria at 3 Month Intervals | at 3 month intervals | |
| Biochemical Response at 3 Month Intervals | at 3 month intervals up to 18 moths |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Rudolf Arnold, MD, Prof | Philipps University Marburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Bochum | Germany | ||||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19704057 | Derived | Rinke A, Muller HH, Schade-Brittinger C, Klose KJ, Barth P, Wied M, Mayer C, Aminossadati B, Pape UF, Blaker M, Harder J, Arnold C, Gress T, Arnold R; PROMID Study Group. Placebo-controlled, double-blind, prospective, randomized study on the effect of octreotide LAR in the control of tumor growth in patients with metastatic neuroendocrine midgut tumors: a report from the PROMID Study Group. J Clin Oncol. 2009 Oct 1;27(28):4656-63. doi: 10.1200/JCO.2009.22.8510. Epub 2009 Aug 24. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Octreotide LAR (SMS995) | Octreotide LAR (Long-acting release) 30 mg intramuscularly every 28 days |
| FG001 | Placebo | Sodium chloride intramuscularly every 28 days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo | Drug | Sodium chloride intramuscularly every 28 days |
|
| Symptom Control at 3 Month Intervals | at 3 month intervals up to 18 moths |
| Quality of Life (Standardized Questionnaire) at Three-month Intervals in Comparison With the Start of the Study | at three-month intervals |
| Survival | at least on a monthly basis |
| Dresden |
| Germany |
| Novartis Investigative Site | Halle | Germany |
| Novartis Investigative Site | Hamburg | Germany |
| Novartis Investigative Site | Kiel | Germany |
| Novartis Investigative Site | Leipzig | Germany |
| Novartis Investigative Site | Mainz | Germany |
| Novartis Investigative Site | Marburg | 35033 | Germany |
| Novartis Investigative Site | Marburg | Germany |
| Novartis Investigative Site | München | Germany |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Octreotide LAR (SMS995) | Octreotide LAR (Long-acting release) 30 mg intramuscularly every 28 days |
| BG001 | Placebo | Sodium chloride intramuscularly every 28 days |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Tumor Progression Documented by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) | Median time to tumor progression at the time of the planned interim analysis that includes all data observed until June 2008. | Conservative Intent to Treat (ITT) population consisting of all participants who received study drug. 3 participants in the Octreotide group and 1 participant in the placebo group without liver involvement at the beginning of the study were excluded from this analysis. | Posted | Median | 95% Confidence Interval | Months | Up to 7 years |
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| Secondary | Objective Response Rates According to World Health Organization (WHO) Criteria at 3 Month Intervals | Not Posted | at 3 month intervals | Participants | |||||||||||||||||||||||||||||||||||
| Secondary | Biochemical Response at 3 Month Intervals | Not Posted | at 3 month intervals up to 18 moths | Participants | |||||||||||||||||||||||||||||||||||
| Secondary | Symptom Control at 3 Month Intervals | Not Posted | at 3 month intervals up to 18 moths | Participants | |||||||||||||||||||||||||||||||||||
| Secondary | Quality of Life (Standardized Questionnaire) at Three-month Intervals in Comparison With the Start of the Study | Not Posted | at three-month intervals | Participants | |||||||||||||||||||||||||||||||||||
| Secondary | Survival | Not Posted | at least on a monthly basis | Participants |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Octreotide LAR (SMS995) | Octreotide LAR (Long-acting release) 30 mg intramuscularly every 28 days | 11 | 42 | 19 | 42 | ||
| EG001 | Placebo | Sodium chloride intramuscularly every 28 days | 10 | 43 | 11 | 43 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| General Disorder | General disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal disorders | Gastrointestinal disorders | Systematic Assessment |
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| Hematopoietic system | Blood and lymphatic system disorders |
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| General Health | General disorders |
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The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carmen Schade-Brittinger | KKS Marburg | 0049-6421-2866458 | carmen.brittinger@kks.uni-marburg.de |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D004194 | Disease |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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