Clinical trial NCT01364415: Dose Escalation Study of Pasireotide (SOM230) in Patients With Advanced Neuroendocrine Tumors (NETs)
Official title: A Phase I, Multi-center, Open-label, Dose Escalation Study of Pasireotide (SOM230) LAR in Patients With Advanced Neuroendocrine Tumors (NETs)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neuroendocrine Tumors
Keywords: MTD
pasireotide
LAR
NETs
advanced neuroendocrine tumors
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-06-02
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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/exclusion criteria may apply

Primary outcomes:
measure: Determine the MTD/RP2D of pasireotide LAR when administered i.m. q28 days to patients with advanced NETs
timeFrame: Sequentiona 56 day cohorts until the MTD is determined
Secondary outcomes:
measure: assess the safety and tolerability of pasireotide LAR
timeFrame: minimum of twelve 28 day cycles to approximately eighteen 28 day cycles
measure: assess the pharmacokinetics (PK) of pasireotide LAR
timeFrame: minimum of twelve 28 day cycles to approximately eighteen 28 day cycles
measure: assess the pharmacodynamics (PD) of pasireotide LAR
timeFrame: minimum of twelve 28 day cycles to approximately eighteen 28 day cycles
measure: assess the preliminary efficacy (anti-tumor activity) of pasireotide LAR.
timeFrame: minimum of twelve 28 day cycles to approximately eighteen 28 day cycles
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center Cedars Sinai 4
state: California
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center & Research Institute SC-1
state: Florida
city: Boston
country: United States
facility: Dana Farber Cancer Institute SC-6
state: Massachusetts
city: Houston
country: United States
facility: University of Texas/MD Anderson Cancer Center UT MD Anderson Cancer Ctr
state: Texas
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: 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.