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This study designed to determine the Maximum Tolerated Dose (MTD) for patients with advanced Neuroendocrine Tumors (NETs) and to characterize the safety, tolerability, Pharmacokinetics and preliminary efficacy of pasireotide LAR administered i.m. once every 28 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pasireotide LAR | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pasireotide LAR | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine the MTD/RP2D of pasireotide LAR when administered i.m. q28 days to patients with advanced NETs | Frequency of dose-limiting toxicities (DLTs) at each dose level associated with q28 days administration of pasireotide LAR during the first 2 treatment cycles. | Sequentiona 56 day cohorts until the MTD is determined |
| Measure | Description | Time Frame |
|---|---|---|
| assess the safety and tolerability of pasireotide LAR | Incidence of adverse drug events, overall and by severity and incidence of serious adverse events and laboratory abnormalities. Also, changes in laboratory assessments, electrocardiograms, Holter monitor, imaging for gallstones, and assessment of physical examinations such as vital signs | minimum of twelve 28 day cycles to approximately eighteen 28 day cycles |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center Cedars Sinai 4 | Los Angeles | California | 90048 | United States | ||
| H. Lee Moffitt Cancer Center & Research Institute SC-1 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28721067 | Derived | Yao JC, Chan JA, Mita AC, Kundu MG, Hermosillo Resendiz K, Hu K, Ravichandran S, Strosberg JR, Wolin EM. Phase I dose-escalation study of long-acting pasireotide in patients with neuroendocrine tumors. Onco Targets Ther. 2017 Jun 27;10:3177-3186. doi: 10.2147/OTT.S128547. eCollection 2017. |
| Label | URL |
|---|---|
| Results for CSOM230D2101 can be found on the Novartis Clinical Trial Results Website | View source |
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| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C517782 | pasireotide |
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| assess the pharmacokinetics (PK) of pasireotide LAR | Pasireotide Cmax and Ctrough | minimum of twelve 28 day cycles to approximately eighteen 28 day cycles |
| assess the pharmacodynamics (PD) of pasireotide LAR | Changes from baseline values in IGF-1, chromogranin A and neuron-specific enolase | minimum of twelve 28 day cycles to approximately eighteen 28 day cycles |
| assess the preliminary efficacy (anti-tumor activity) of pasireotide LAR. | Disease control rate (CR+PR+SD as assessed by RECIST 1.0). Also measure progression free survival (PFS). | minimum of twelve 28 day cycles to approximately eighteen 28 day cycles |
| Tampa |
| Florida |
| 33612 |
| United States |
| Dana Farber Cancer Institute SC-6 | Boston | Massachusetts | 02215 | United States |
| University of Texas/MD Anderson Cancer Center UT MD Anderson Cancer Ctr | Houston | Texas | 77030-4009 | United States |
| D009380 | Neoplasms, Nerve Tissue |