Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pasireotide sub-cutaneous formulation · 1 trial · 1 indication
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 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 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. Patients must have histologically or cytologically confirmed unresectable (stage III) and/or metastatic (stage IV) melanoma or unresectable and/or metastatic Merkel cell carcinoma. 2. Melanoma patients should have no mutation in BRAF and NRAS genes 3. Patients should have les...
Pasireotide sub-cutaneous is an investigational small molecule being studied for Cushing's Disease and for metastatic melanoma and Merkel cell carcinoma. It is developed by Novartis AG and is in clinical development, with completed trials in these indications.
Pasireotide sub-cutaneous is a somatostatin analog that targets somatostatin receptors. It is being studied for its effects in endocrine conditions like Cushing's Disease and in certain cancers, though specific receptor subtypes are not detailed here.
Pasireotide sub-cutaneous is developed by Novartis AG, a pharmaceutical company listed on the stock exchange under the ticker NVS. The drug is being investigated for Cushing's Disease and for metastatic melanoma and Merkel cell carcinoma.
Pasireotide sub-cutaneous has completed a Phase 3 trial for Cushing's Disease and a Phase 1 trial for metastatic melanoma and Merkel cell carcinoma. It is not approved and remains investigational, with no active trials currently listed.
Pasireotide sub-cutaneous has been studied in two completed trials. NCT01582061 was a Phase 3 expanded access study in Cushing's Disease with 104 participants. NCT01652547 was a Phase 1 dose escalation study in metastatic melanoma and Merkel cell carcinoma with 10 participants.
Pasireotide sub-cutaneous is a formulation of pasireotide, also known as SOM230. The sub-cutaneous version is administered by injection under the skin, and it is being studied for Cushing's Disease and certain cancers.