Dose Escalation Study of Pasireotide (SOM230) in Patients With Advanced Neuroendocrine Tumors (NETs)

Neuroendocrine Tumors Clinical Trial

Official title:

A Phase I, Multi-center, Open-label, Dose Escalation Study of Pasireotide (SOM230) LAR in Patients With Advanced Neuroendocrine Tumors (NETs)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01364415
• Other study ID #: CSOM230D2101
• Status: Completed
• Phase: Phase 1
• Start date: August 2011
• Est. completion date: April 2016

Study information

• Verified date: June 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuroendocrine Tumors

Intervention

Drug:
• Pasireotide LAR

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute SC-6	Boston	Massachusetts
United States	University of Texas/MD Anderson Cancer Center UT MD Anderson Cancer Ctr	Houston	Texas
United States	Cedars Sinai Medical Center Cedars Sinai 4	Los Angeles	California
United States	H. Lee Moffitt Cancer Center & Research Institute SC-1	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	assess the pharmacokinetics (PK) of pasireotide LAR	Pasireotide Cmax and Ctrough	minimum of twelve 28 day cycles to approximately eighteen 28 day cycles
Secondary	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
Secondary	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

External Links

•   Results for CSOM230D2101 can be found on the Novartis Clinical Trial Results Website