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Also known as Octreotide LAR, Octreotide, Octreotide acetate
SMS995 · 10 trials · 12 indications
PFS is defined as the time from randomization to the first occurrence of progression (centrally assessed by Blinded Independent Review Committee (BIRC) according to RECIST v1.1) or death due to any cause.
Progression free survival (PFS) is defined as the time from randomization to the date of first documented disease progression or death from any cause. The primary analysis of PFS was based on the independent central adjudicated assessment using Kaplan-Meier method.
Growth hormone (GH) level was the average value measured in 3 blood samples collected at 15 minute intervals at each visit. GH was measured with an automated immunometric assay in a central laboratory.
Insulin-like growth factor 1 (IGF-1) level was measured in a blood sample with an automated immunometric assay in a central laboratory.
Treatment Success was defined as: less than 2 episodes of vomiting on average per day for the 4 days prior to Day 14 \[from Day 10 to Day 13\] and no use of an Nasogastric Tube (NGT) since at least Day 10 and no use of an anticholinergic agent until Day 14. Treatment Failure is defined as: 2 or more episodes of vomiting per day on average for the 4 days prior to Day 14 or use of an NGT after Day 9 or use of an anticholinergic agent before Day 14 or withdrawal from the trial between Day 1 and Day 14 (included), whatever the cause.
| Arm | Type | Description |
|---|---|---|
| [177Lu]Lu-DOTA-TATE + Octreotide LAR | EXPERIMENTAL | Participants in this arm will receive \[177Lu\]Lu-DOTA-TATE plus Octreotide long-acting release (LAR). |
| Octreotide LAR | ACTIVE_COMPARATOR | Participants in this arm will receive Octreotide LAR only. |
| Octreotide+ Everolimus | EXPERIMENTAL | Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1. |
| Octreotide+ Placebo | PLACEBO_COMPARATOR | Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1. |
| Octreotide 30 mg every 21 days | EXPERIMENTAL | Patients received octreotide 30 mg every 21 days intramuscularly (im) for 6 months, a total of 8 doses. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor. |
| Octreotide 60 mg every 28 days | EXPERIMENTAL | Patients received octreotide 60 mg every 28 days intramuscularly (im) for 6 months, a total of 6 doses. Octreotide mg was administered as two 30 mg injections. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor. |
| SMS995 | EXPERIMENTAL | - |
| Octreotide | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days. |
| Sandostatin | EXPERIMENTAL | - |
| 1 | EXPERIMENTAL | - |
| 2 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| [177Lu]Lu-DOTA-TATE | RADIATION | \[177Lu\]Lu-DOTA-TATE will be administered 4 times during treatment period with frequency of every 8 weeks (Q8W) |
| Octreotide LAR | DRUG | Octreotide LAR will be administered Q8W when co-administered with \[177Lu\]Lu-DOTA-TATE in the investigational arm followed by Q4W. In the control arm Octreotide LAR will be administered Q4W. |
| Octreotide | DRUG | Octreotide 30 mg intramuscularly (i.m.) every 28 days. |
| Placebo | DRUG | A 10-mg oral daily dosing regimen (two 5-mg tablets) of matching placebo. |
| Everolimus | DRUG | A 10-mg oral daily dosing regimen (two 5-mg tablets) of everolimus. |
| Octreotide acetate 30 mg suspension | DRUG | Each vial of study medication contained octreotide acetate 30 mg in a microencapsulated biodegradable polymer, poly (DL-lactide-co-glycolide) (D-(+)glucose), with 17% w/w mannitol in an approximate octreotide:polymer ratio of 1:20. The vehicle contained 0.5% sodium carboxymethylcellulose. |
| Octreotide (Immediate release) | DRUG | Immediate-release Octreotide supplied in 100 µg/mL ampules. |
| methylprednisolone | DRUG | methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections). |
| SMS995 | DRUG | - |
Inclusion Criteria: * Presence of metastasized or locally advanced, unresectable (curative intent), histologically proven, well differentiated Grade 1 or Grade 2 (Ki-67 \<10%) gastroenteropancreatic neuroendocrine tumor (GEP-NET) diagnosed within 6 months prior to screening. * Participants with hig...
Top 5 of 9 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 1 | PHASE3 | Eluxadoline |
| Ardelyx, Inc. | ARDX | 2 | PHASE3 | Tenapanor |
| Disc Medicine, Inc. | IRON | 1 | PHASE2 | DISC-0974 |
| Eli Lilly and Company | LLY | 2 | PHASE2 | LY3537031 |
| GSK plc Sponsored ADR | GSK | 1 | PHASE2 | Camlipixant |
SMS995 is an investigational small molecule being developed for Irritable Bowel Syndrome (IBS), a gastrointestinal condition. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
SMS995 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker NVS. The drug is currently in Phase 1 clinical trials for Irritable Bowel Syndrome.
SMS995 is in Phase 1 clinical development. It is an investigational drug for Irritable Bowel Syndrome and has not been approved by the FDA or other regulatory agencies. One Phase 1 trial has been completed.
SMS995 has one completed Phase 1 clinical trial, registered under NCT00584298. The trial, titled 'Feasibility and Reproducibility of Barostat Assessments of Colorectal Sensation During Colorectal Distention and Its Pharmacological Modulation Using Octreotide,' enrolled 50 female participants with Irritable Bowel Syndrome across the United States, Canada, Sweden, and the United Kingdom.
No, SMS995 is not the same as octreotide. The completed Phase 1 trial NCT00584298 used octreotide as a pharmacological modulator to assess colorectal sensation, but SMS995 is the investigational drug being developed for Irritable Bowel Syndrome. The trial was designed to evaluate the feasibility of barostat assessments.