Trial Outcomes & Findings for Antiproliferative Effect of Octreotide in Patients With Metastasized Neuroendocrine Tumors of the Midgut (NCT NCT00171873)

Results Overview

Median time to tumor progression at the time of the planned interim analysis that includes all data observed until June 2008.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

85 participants

Primary outcome timeframe

Up to 7 years

Results posted on

2020-03-26

Participant Flow

Participant milestones

Participant milestones
Measure	Octreotide LAR (SMS995) Octreotide LAR (Long-acting release) 30 mg intramuscularly every 28 days	Placebo Sodium chloride intramuscularly every 28 days
Overall Study STARTED	42	43
Overall Study COMPLETED	33	40
Overall Study NOT COMPLETED	9	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Octreotide LAR (SMS995) Octreotide LAR (Long-acting release) 30 mg intramuscularly every 28 days	Placebo Sodium chloride intramuscularly every 28 days
Overall Study Withdrawal by Subject	4	2
Overall Study Adverse Event	5	0
Overall Study Switched to Octreotide	0	1

Baseline Characteristics

Antiproliferative Effect of Octreotide in Patients With Metastasized Neuroendocrine Tumors of the Midgut

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Octreotide LAR (SMS995) n=42 Participants Octreotide LAR (Long-acting release) 30 mg intramuscularly every 28 days	Placebo n=43 Participants Sodium chloride intramuscularly every 28 days	Total n=85 Participants Total of all reporting groups
Age, Continuous	63.5 years n=5 Participants	61 years n=7 Participants	62 years n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	20 Participants n=7 Participants	42 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	23 Participants n=7 Participants	43 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 7 years

Population: 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.

Median time to tumor progression at the time of the planned interim analysis that includes all data observed until June 2008.

Outcome measures

Outcome measures
Measure	Octreotide LAR (SMS995) n=39 Participants Octreotide LAR (Long-acting release) 30 mg intramuscularly every 28 days	Placebo n=42 Participants Sodium chloride intramuscularly every 28 days
Time to Tumor Progression Documented by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)	14.3 Months Interval 11.0 to 28.8	6.0 Months Interval 3.7 to 9.4

SECONDARY outcome

Timeframe: at 3 month intervals

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at 3 month intervals up to 18 moths

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at 3 month intervals up to 18 moths

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at three-month intervals

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at least on a monthly basis

Outcome measures

Outcome data not reported

Adverse Events

Octreotide LAR (SMS995)

Serious events: 11 serious events

Other events: 19 other events

Deaths: 0 deaths

Placebo

Serious events: 10 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Octreotide LAR (SMS995) n=42 participants at risk Octreotide LAR (Long-acting release) 30 mg intramuscularly every 28 days	Placebo n=43 participants at risk Sodium chloride intramuscularly every 28 days
General disorders General Disorder	26.2% 11/42	23.3% 10/43

Other adverse events

Other adverse events
Measure	Octreotide LAR (SMS995) n=42 participants at risk Octreotide LAR (Long-acting release) 30 mg intramuscularly every 28 days	Placebo n=43 participants at risk Sodium chloride intramuscularly every 28 days
Gastrointestinal disorders Gastrointestinal disorders	14.3% 6/42	18.6% 8/43
Blood and lymphatic system disorders Hematopoietic system	11.9% 5/42	2.3% 1/43
General disorders General Health	19.0% 8/42	4.7% 2/43

Additional Information

Carmen Schade-Brittinger

KKS Marburg

Phone: 0049-6421-2866458

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER