NCT01364415

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2011

Longer than P75 for phase_1

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2011

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 2, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

December 21, 2020

Status Verified

June 1, 2016

Enrollment Period

4.7 years

First QC Date

May 18, 2011

Last Update Submit

December 17, 2020

Conditions

Neuroendocrine Tumors

Keywords

MTDpasireotideLARNETsadvanced neuroendocrine tumors

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • assess the safety and tolerability of pasireotide LAR

    minimum of twelve 28 day cycles to approximately eighteen 28 day cycles

  • assess the pharmacokinetics (PK) of pasireotide LAR

    minimum of twelve 28 day cycles to approximately eighteen 28 day cycles

  • assess the pharmacodynamics (PD) of pasireotide LAR

    minimum of twelve 28 day cycles to approximately eighteen 28 day cycles

  • assess the preliminary efficacy (anti-tumor activity) of pasireotide LAR.

    minimum of twelve 28 day cycles to approximately eighteen 28 day cycles

Study Arms (1)

Pasireotide LAR

EXPERIMENTAL
Drug: Pasireotide LAR

Interventions

Pasireotide LARDRUG
Also known as: SOM230
Pasireotide LAR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥18 yrs old, histologically confirmed advanced well or moderately differentiated neuroendocrine tumor/carcinoma
  • unresectable metastatic NET tumor with measurable disease
  • life expectancy ≥ 12 weeks

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Cedars Sinai Medical Center Cedars Sinai 4

Los Angeles, California, 90048, United States

Location

H. Lee Moffitt Cancer Center & Research Institute SC-1

Tampa, Florida, 33612, United States

Location

Dana Farber Cancer Institute SC-6

Boston, Massachusetts, 02215, United States

Location

University of Texas/MD Anderson Cancer Center UT MD Anderson Cancer Ctr

Houston, Texas, 77030-4009, United States

Location

Related Publications (1)

  • 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.

    PMID: 28721067DERIVED

Related Links

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

pasireotide

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve Tissue

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2011

First Posted

June 2, 2011

Study Start

August 1, 2011

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

December 21, 2020

Record last verified: 2016-06

Locations

US(4)