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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT01364415

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

7.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neuroendocrine Tumors	Drug: Pasireotide LAR	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

29 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2011

Actual Primary Completion Date :

Apr 1, 2016

Actual Study Completion Date :

Apr 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pasireotide LAR	Drug: Pasireotide LAR Other Names: SOM230

Arm

Intervention/Treatment

Experimental: Pasireotide LAR

Drug: Pasireotide LAR

Other Names:

SOM230

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cedars Sinai Medical Center Cedars Sinai 4	Los Angeles	California	United States	90048
2	H. Lee Moffitt Cancer Center & Research Institute SC-1	Tampa	Florida	United States	33612
3	Dana Farber Cancer Institute SC-6	Boston	Massachusetts	United States	02215
4	University of Texas/MD Anderson Cancer Center UT MD Anderson Cancer Ctr	Houston	Texas	United States	77030-4009