Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as pasireotide LAR
SOM230C · 7 trials · 7 indications
Percentage of participants who achieved biochemical control defined as GH \<1μg/L and IGF-1 \<ULN at week 36.
Percentage of participants who achieved biochemical control defined as GH \<1μg/L and IGF-1 \<ULN at week 36, for participants who had been up-titrated with pasireotide LAR 60 mg.
Percentage of participants who achieved biochemical control defined as GH \<1μg/L and IGF-1 \<ULN at week 36.
Percentage of participants who achieved biochemical control defined as GH \<1μg/L and IGF-1 \<ULN at week 36, overall by baseline diabetic status.
Percentage of participants who achieved biochemical control defined as GH \<1μg/L and IGF-1 \<ULN at week 36, by previous treatment and overall - last observation carried forward (LOCF)
Percentage of participants that attained a mean urinary free cortisol (mUFC) \<= 1.0 x upper limit of normal (ULN) at Month 7 regardless of dose up-titration at Month 4. Patients who discontinued before month 4 evaluations classed as non-responders. For patients missing month 7 mUFC assessments, the last available mUFC assessment at or after month 4 was carried forward as the month 7 mUFC assessment value.
Progression is defined using Modified Macdonald Criteria , using a \>/= 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR clear clinical worsening or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) at Month 9 were to be considered as "progression-free" based on RECIST v1.1. Patients with missing tumor assessment, or with overall lesion response "unknown" at Month 9 were considered as "non progression-free", unless any of the following assessments at Week 48 or Week 52 indicate CR, PR, or SD, in which case the patient was to be considered as progression-free at Month 9. Patients discontinuing the study for any reason prior to the 9 month assessment were to be considered as "non progression-free".
Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility.The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor. A change ≥ 20% in the original volume of the tumor was considered to be clinically significant. Evaluable participants required tumor volume assessment at baseline and at week 24.
Percentage of participants with a reduction of mean growth hormone (GH) levels to \< 2.5 µg/L and the normalization of insulin-like growth factor-1 (IGF-1) to within normal limits (age and sex related) at 3 months across all doses
Frequency of dose-limiting toxicities (DLTs) at each dose level associated with q28 days administration of pasireotide LAR during the first 2 treatment cycles.
| Arm | Type | Description |
|---|---|---|
| Pasireotide LAR | EXPERIMENTAL | Patients who qualify for the core phase of the study will be treated with pasireotide LAR 40 mg initially. Patients not achieving biochemical control can be up-titrated to pasireotide LAR 60 mg. |
| 10 mg LAR dose | EXPERIMENTAL | Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. |
| 30 mg LAR dose | EXPERIMENTAL | Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. |
| SOM230C | EXPERIMENTAL | Monthly SOM230C (pasireotide LAR) - 60 mg intramuscularly (Single-Arm Trial) |
| Everolimus | EXPERIMENTAL | Everolimus 10 mg taken orally (p.o) once daily starting on Day 1 |
| Pasireotide LAR and Everolimus Combination | EXPERIMENTAL | Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily starting on Day 1 |
| Pasireotide LAR 20mg | EXPERIMENTAL | Enrolled patients were randomized to 20mg pasireotide LAR. |
| Pasireotide LAR 40mg | EXPERIMENTAL | Enrolled patients were randomized to 40mg pasireotide LAR. |
| Pasireotide LAR 60mg | EXPERIMENTAL | Enrolled patients were randomized to 60mg pasireotide LAR. |
| Name | Type | Description |
|---|---|---|
| Pasireotide LAR | DRUG | Pasireotide 40 mg and 60 mg. Pasireotide 20 mg which was allowed for dose decrease in case of adverse event. |
| SOM230 LAR 30 mg | DRUG | starting dose of 30 mg i.m. administered once every 28 days for 4 months, followed by dose up-titration or continuation of starting dose. |
| SOM230 LAR 10 mg | DRUG | starting does of SOM230 LAR 10 mg i.m. administered once every 28 days for 4 months, followed by dose up-titration or continuation of the starting dose. |
| SOM230C | DRUG | Injection in the buttocks every 28 days |
| Everolimus | DRUG | 10 mg tables administered orally once a day |
| Pasireotide LAR and Everolimus Combination | DRUG | Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily |
Inclusion Criteria: * Written informed consent * Male and female patients ≥18 years * Patients with confirmed diagnosis of inadequately controlled acromegaly (mean GH concentration ≥1 μg/L and sex- and age-adjusted IGF-1 \>1.3 x ULN) * Patients treated with octreotide LAR (30 mg or 40 mg) or lanreo...
SOM230C is being studied for the treatment of meningioma, a type of tumor that arises from the membranes surrounding the brain and spinal cord. Specifically, it has been evaluated in patients with recurrent or progressive meningioma. It is an investigational therapy and has not been approved for any indication.
SOM230C is being developed by Novartis AG, a pharmaceutical company traded under the ticker NVS. Novartis conducted the clinical research on this compound for meningioma.
SOM230C is in Phase 2 clinical development. It has been tested in a completed Phase 2 trial for recurrent or progressive meningioma. It is not approved by the FDA and remains an investigational drug.
SOM230C has been studied in one clinical trial: NCT00859040, titled "Monthly SOM230C for Recurrent or Progressive Meningioma." This Phase 2 trial enrolled 34 patients in the United States and is now completed. No active trials are currently listed.
SOM230C is a small molecule drug. Its mechanism of action has not been publicly detailed in the available information. It is being investigated for its effects in meningioma.