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

Primary Purpose

Neuroendocrine Tumors

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Pasireotide LAR
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuroendocrine Tumors focused on measuring MTD, pasireotide, LAR, NETs, advanced neuroendocrine tumors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Cedars Sinai Medical Center Cedars Sinai 4
  • H. Lee Moffitt Cancer Center & Research Institute SC-1
  • Dana Farber Cancer Institute SC-6
  • University of Texas/MD Anderson Cancer Center UT MD Anderson Cancer Ctr

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pasireotide LAR

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
assess the pharmacokinetics (PK) of pasireotide LAR
Pasireotide Cmax and Ctrough
assess the pharmacodynamics (PD) of pasireotide LAR
Changes from baseline values in IGF-1, chromogranin A and neuron-specific enolase
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).

Full Information

First Posted
May 18, 2011
Last Updated
December 17, 2020
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01364415
Brief Title
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

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Tumors
Keywords
MTD, pasireotide, LAR, NETs, advanced neuroendocrine tumors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pasireotide LAR
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Pasireotide LAR
Other Intervention Name(s)
SOM230
Primary Outcome Measure Information:
Title
Determine the MTD/RP2D of pasireotide LAR when administered i.m. q28 days to patients with advanced NETs
Description
Frequency of dose-limiting toxicities (DLTs) at each dose level associated with q28 days administration of pasireotide LAR during the first 2 treatment cycles.
Time Frame
Sequentiona 56 day cohorts until the MTD is determined
Secondary Outcome Measure Information:
Title
assess the safety and tolerability of pasireotide LAR
Description
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
Time Frame
minimum of twelve 28 day cycles to approximately eighteen 28 day cycles
Title
assess the pharmacokinetics (PK) of pasireotide LAR
Description
Pasireotide Cmax and Ctrough
Time Frame
minimum of twelve 28 day cycles to approximately eighteen 28 day cycles
Title
assess the pharmacodynamics (PD) of pasireotide LAR
Description
Changes from baseline values in IGF-1, chromogranin A and neuron-specific enolase
Time Frame
minimum of twelve 28 day cycles to approximately eighteen 28 day cycles
Title
assess the preliminary efficacy (anti-tumor activity) of pasireotide LAR.
Description
Disease control rate (CR+PR+SD as assessed by RECIST 1.0). Also measure progression free survival (PFS).
Time Frame
minimum of twelve 28 day cycles to approximately eighteen 28 day cycles

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Cedars Sinai Medical Center Cedars Sinai 4
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
H. Lee Moffitt Cancer Center & Research Institute SC-1
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Dana Farber Cancer Institute SC-6
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Texas/MD Anderson Cancer Center UT MD Anderson Cancer Ctr
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28721067
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.
Results Reference
derived
Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=15767
Description
Results for CSOM230D2101 can be found on the Novartis Clinical Trial Results Website

Learn more about this trial

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

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