Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Pasireotide sub-cutaneous
Pasireotide sub-cutaneous formulation · 2 trials · 2 indications
Only AEs occurring on or after the start of study treatment and no more than 28 days after the discontinuation of study treatment. A patient with multiple occurrences of an AE under one treatment is counted only once in the AE category for that treatment. A patient with multiple severity grades for an AE while on a treatment, is only counted under the maximum grade.
Number of patients with AEs (overall and by severity) SAEs according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Number of patients with laboratory abnormalities according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Number of patients with ECG according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Number of patients with vital sign abnormalities according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
| Arm | Type | Description |
|---|---|---|
| Pasireotide 600 μg | EXPERIMENTAL | Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients. Mean daily dose category is defined on the mean daily dose considering the following grouping rule: 600 μg bid group includes all patients whose mean daily dose \< 1500 μg /day. |
| Pasireotide 900 μg | EXPERIMENTAL | Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg. Mean daily dose category is defined on the mean daily dose considering the following grouping rule: 900 μg bid group includes all patients whose mean daily dose ≥ 1500 μg /day |
| Pasireotide sub-cutaneous formulation | EXPERIMENTAL | Pasireotide, will be administered to all patients by s.c. injection, beginning with a dose of 300 μg administered three times daily (t.i.d.) for 2 weeks. If no pasireotide-related clinically meaningful/uncontrolled grade 3 or grade 4 adverse events occur the dose will be administered to all patients at an increased dose of 600 μg t.i.d. for 2 weeks, followed by 2 weeks of 900 μg t.i.d. and followed by 2 weeks of 1200 μg t.i.d. After the 8 weeks period, patients will be kept on treatment drug (highest dose without clinically meaningful/uncontrolled AEs), switched to the corresponding pasireotide LAR dose and followed up for an extra 6 months. |
| Pasireotide long acting release | EXPERIMENTAL | At the start of the follow-up phase patients will be switched to pasireotide LAR administered intramuscularly every 28 days by using the following conversion algorithm so that the steady state PK exposure (Cmax and Ctrough) of pasireotide will be maintained: 300 μg s.c. t.i.d. fi 20mg LAR i.m. q 28 days 600 μg s.c. t.i.d. fi 40 mg LAR i.m. q 28 days 900 μg s.c. t.i.d. fi 60 mg LAR i.m. q 28 days 1200 μg s.c. t.id. fi 80 mg LAR i.m. q 28 days In addition, all patients will keep the treatment with pasireotide s.c. during the first 2 weeks of the LAR phase. The use of s.c. dosing during the initial 2 week period following the first LAR dose provides an appropriate level of medication during the LAR nadir. |
| Name | Type | Description |
|---|---|---|
| Pasireotide sub-cutaneous | DRUG | Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg, 600 μg, or 300 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg and 600 μg for glucose impaired metabolism patients |
| Pasireotide sub-cutaneous formulation | DRUG | Pasireotide, will be administered to all patients by s.c. injection, beginning with a dose of 300 μg administered three times daily (t.i.d.) for 2 weeks. If no pasireotide-related clinically meaningful/uncontrolled grade 3 or grade 4 adverse events occur the dose will be administered to all patients at an increased dose of 600 μg t.i.d. for 2 weeks, followed by 2 weeks of 900 μg t.i.d. and followed by 2 weeks of 1200 μg t.i.d. After the 8 weeks period, patients will be kept on treatment drug (highest dose without clinically meaningful/uncontrolled AEs) , switched to the corresponding pasireotide LAR dose and followed up for an extra 6 months. |
| Pasireotide lon acting release formulation | DRUG | At the start of the follow-up phase patients will be switched to pasireotide LAR administered intramuscularly every 28 days by using the following conversion algorithm so that the steady state PK exposure (Cmax and Ctrough) of pasireotide will be maintained: 300 μg s.c. t.i.d. fi 20mg LAR i.m. q 28 days 600 μg s.c. t.i.d. fi 40 mg LAR i.m. q 28 days 900 μg s.c. t.i.d. fi 60 mg LAR i.m. q 28 days 1200 μg s.c. t.id. fi 80 mg LAR i.m. q 28 days In addition, all patients will keep the treatment with pasireotide s.c. during the first 2 weeks of the LAR phase. The use of s.c. dosing during the initial 2 week period following the first LAR dose provides an appropriate level of medication during the LAR nadir. |
Inclusion criteria: 1. Written informed consent obtained prior to any screening procedures 2. Male or female patients aged 18 years or greater 3. Patients with confirmed diagnosis of Cushing's disease as evidenced by mean urinary free cortisol of three 24-hour urine samples collected during the 3-w...
Pasireotide sub-cutaneous formulation is an injectable small molecule developed by Novartis AG (ticker NVS). It is being studied in Cushing's disease, metastatic melanoma, and Merkel cell carcinoma. The subcutaneous version is distinct from the long-acting release (LAR) formulation, which is given less frequently.
Pasireotide sub-cutaneous formulation targets somatostatin receptors SSTR2, SSTR3, SSTR1, and SSTR5, acting as an agonist at these receptors. This receptor activity underlies its use in conditions driven by hormonal hypersecretion, such as Cushing's disease, and in tumors where somatostatin receptor signaling is relevant.
Pasireotide sub-cutaneous formulation is developed by Novartis AG, which trades under the ticker NVS. Novartis is the sponsor of the clinical studies evaluating the subcutaneous formulation in Cushing's disease and in metastatic melanoma and Merkel cell carcinoma.
Pasireotide sub-cutaneous formulation has been evaluated in a Phase 3 expanded access study in Cushing's disease, which is completed. A Phase 1 exploratory study in metastatic melanoma and Merkel cell carcinoma is also completed. No active trials are currently listed for this formulation.
Pasireotide sub-cutaneous formulation has been studied in two completed trials. NCT01582061 was a Phase 3 open-label expanded access study in Cushing's disease with 104 patients across multiple countries. NCT01652547 was a Phase 1 exploratory dose escalation study in metastatic melanoma and Merkel cell carcinoma with 10 patients in Germany and Switzerland.
Yes, pasireotide sub-cutaneous is another name for pasireotide sub-cutaneous formulation. Both refer to the same injectable small molecule developed by Novartis AG. The subcutaneous route distinguishes it from the long-acting release (LAR) version of pasireotide.