Neuroendocrine Tumors
Conditions
Keywords
MTD, pasireotide, LAR, NETs, advanced neuroendocrine tumors
Brief summary
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.
Interventions
DRUGPasireotide LAR
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥18 yrs old, histologically confirmed advanced well or moderately differentiated neuroendocrine tumor/carcinoma * unresectable metastatic NET tumor with measurable disease * life expectancy ≥ 12 weeks
Exclusion criteria
* Patients with CNS metastases who are neurologically unstable or requiring increasing doses of steroids to control their CNS disease * patients with known hypersensitivity to somatostatin analogs * patients with symptomatic cholelithiasis in the past 2 months * patients with history of another known primary malignancy with exception of non-melanoma skin cancer or carcinoma in situ of uterine cervix * patients with known history of hepatitis C or chronic active hepatitis B * patients with diagnosis of HIV. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine the MTD/RP2D of pasireotide LAR when administered i.m. q28 days to patients with advanced NETs | Sequentiona 56 day cohorts until the MTD is determined | Frequency of dose-limiting toxicities (DLTs) at each dose level associated with q28 days administration of pasireotide LAR during the first 2 treatment cycles. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| assess the safety and tolerability of pasireotide LAR | minimum of twelve 28 day cycles to approximately eighteen 28 day cycles | 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 |
| assess the pharmacokinetics (PK) of pasireotide LAR | minimum of twelve 28 day cycles to approximately eighteen 28 day cycles | Pasireotide Cmax and Ctrough |
| assess the pharmacodynamics (PD) of pasireotide LAR | minimum of twelve 28 day cycles to approximately eighteen 28 day cycles | Changes from baseline values in IGF-1, chromogranin A and neuron-specific enolase |
| assess the preliminary efficacy (anti-tumor activity) of pasireotide LAR. | minimum of twelve 28 day cycles to approximately eighteen 28 day cycles | Disease control rate (CR+PR+SD as assessed by RECIST 1.0). Also measure progression free survival (PFS). |
Countries
United States
Outcome results
None listed