Trial · NCT00088595

Study Evaluating SOM230 in Patients With Metastatic Carcinoid Tumors

NCT00088595, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2011-05-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study Evaluating SOM230 in Patients With Metastatic Carcinoid Tumors. Trials, record NCT00088595. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00088595

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study Evaluating SOM230 in Patients With Metastatic Carcinoid Tumors
NCT number: NCT00088595
Status: Completed
Phases: Phase 2
Enrollment: 45 participants, actual
Lead sponsor: Novartis Pharmaceuticals
Conditions: Carcinoid Tumors
Interventions: Pasireotide (SOM230)
First posted: 2004-08-02
Last updated: 2012-06-04
Results first posted: 2011-05-06
Limitations and caveats: No formal statistical comparisons were performed for this study. Summary statistics were provided to compare the different doses administered for the primary and secondary endpoints.

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Symptom Control (Diarrhea/Flushing) Using a Patient Symptom Diary	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	Duration of Complete Symptom Control (Days) by Dose Class	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.
Secondary	Duration of Partial Symptom Control (Days) by Dose Class	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.
Secondary	The Number of Patients (Participants) With Overall Tumor Response	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.
Secondary	The Overall Safety and Tolerability of Pasireotide	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.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Symptom Control (Diarrhea/Flushing) Using a Patient Symptom Diary	15 days	The efficacy analysis population (EAP) consisted of 44 patients all of whom had at least one efficacy assessment available after receiving at least one dose of study drug, but excluded 1 patient who had no post-baseline efficacy assessments.	participants	NUMBER
SECONDARY	Duration of Complete Symptom Control (Days) by Dose Class	15 days	The efficacy analysis population (EAP) consisted of 44 patients all of whom had at least one efficacy assessment available after receiving at least one dose of study drug, but excluded 1 patient who had no post-baseline efficacy assessments. n= the number of patients with complete symptom control.	Days	MEAN
SECONDARY	Duration of Partial Symptom Control (Days) by Dose Class	up to 15 days	The efficacy analysis population (EAP) consisted of 44 patients all of whom had at least one efficacy assessment available after receiving at least one dose of study drug, but excluded 1 patient who had no post-baseline efficacy assessments. n= then number of patients with partial sympton control	Days	MEAN
SECONDARY	The Number of Patients (Participants) With Overall Tumor Response	At least 15 days	The efficacy analysis population (EAP) consisted of 44 patients all of whom had at least one efficacy assessment available after receiving at least one dose of study drug, but excluded 1 patient who had no post-baseline efficacy assessments.	Participants	NUMBER
SECONDARY	The Overall Safety and Tolerability of Pasireotide	At least 15 days	The safety population consisted of all patients who received study drug (i.e. who started the pasireotide injections) and was thus identical to the Intent to treat (ITT) population.	Participants	NUMBER

Source ClinicalTrials.gov

Results by group31

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Symptom Control (Diarrhea/Flushing) Using a Patient Symptom Diary	Pasireotide (Any Dose)	Complete symptom control	3		participants
Symptom Control (Diarrhea/Flushing) Using a Patient Symptom Diary	Pasireotide (Any Dose)	Partial symptom control	9		participants
Symptom Control (Diarrhea/Flushing) Using a Patient Symptom Diary	Pasireotide (Any Dose)	No control	32		participants
Duration of Complete Symptom Control (Days) by Dose Class	Pasireotide >900 - ≤1500 μg		42.0	Standard Deviation 22.68	Days
Duration of Complete Symptom Control (Days) by Dose Class	Pasireotide >1500 - ≤2400 μg		47.0	Standard Deviation NA	Days
Duration of Complete Symptom Control (Days) by Dose Class	Pasireotide Any Dose		43.7	Standard Deviation 16.26	Days
Duration of Partial Symptom Control (Days) by Dose Class	Pasireotide >900-≤1500 μg		89.8	Standard Deviation 95.77	Days
Duration of Partial Symptom Control (Days) by Dose Class	Pasireotide >1500-≤2400 μg		36.3	Standard Deviation 28.73	Days
Duration of Partial Symptom Control (Days) by Dose Class	Pasireotide Any Dose		72.0	Standard Deviation 81.58	Days
The Number of Patients (Participants) With Overall Tumor Response	Pasireotide (Any Dose)	Complete response for complete treatment success	0		Participants

1 to 10 of 31Source ClinicalTrials.gov

See all 31 results by group

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Pasireotide (Any Dose)	45
Overall Study	COMPLETED	Pasireotide (Any Dose)	17
Overall Study	NOT COMPLETED	Pasireotide (Any Dose)	28

Source ClinicalTrials.gov

Adverse events111

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Vertigo	Ear and labyrinth disorders	Pasireotide 300 ≤ 900 μg	3	45
other	Vertigo	Ear and labyrinth disorders	Pasireotide > 900 ≤ 1500 μg	0	43
other	Vertigo	Ear and labyrinth disorders	Pasireotide > 1500 ≤ 2400 μg	1	31
other	Abdominal pain	Gastrointestinal disorders	Pasireotide 300 ≤ 900 μg	8	45
other	Abdominal pain	Gastrointestinal disorders	Pasireotide > 900 ≤ 1500 μg	7	43
other	Abdominal pain	Gastrointestinal disorders	Pasireotide > 1500 ≤ 2400 μg	2	31
other	Defaecation urgency	Gastrointestinal disorders	Pasireotide 300 ≤ 900 μg	0	45
other	Defaecation urgency	Gastrointestinal disorders	Pasireotide > 900 ≤ 1500 μg	0	43
other	Defaecation urgency	Gastrointestinal disorders	Pasireotide > 1500 ≤ 2400 μg	2	31
other	Diarrhoea	Gastrointestinal disorders	Pasireotide 300 ≤ 900 μg	2	45

1 to 10 of 111Source ClinicalTrials.gov

See all 111 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Pasireotide 300 ≤ 900 μg
Total, all-cause mortality	Pasireotide > 900 ≤ 1500 μg
Total, all-cause mortality	Pasireotide > 1500 ≤ 2400 μg
Total, other adverse events	Pasireotide 300 ≤ 900 μg	24	45
Total, other adverse events	Pasireotide > 900 ≤ 1500 μg	20	43
Total, other adverse events	Pasireotide > 1500 ≤ 2400 μg	21	31
Total, serious adverse events	Pasireotide 300 ≤ 900 μg	3	45
Total, serious adverse events	Pasireotide > 900 ≤ 1500 μg	3	43
Total, serious adverse events	Pasireotide > 1500 ≤ 2400 μg	10	31

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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