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Completed

NCT Number: NCT01364415

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

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.

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Key information

Conditions

Neuroendocrine Tumors Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cedars Sinai Medical Center Cedars Sinai 4, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pasireotide LAR

Drug

Other names: SOM230

Primary outcomes

  1. Determine the MTD/RP2D of pasireotide LAR when administered i.m. q28 days to patients with advanced NETs

    Time frame: 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 outcomes

  1. assess the safety and tolerability of pasireotide LAR

    Time frame: 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

  2. assess the pharmacokinetics (PK) of pasireotide LAR

    Time frame: minimum of twelve 28 day cycles to approximately eighteen 28 day cycles

    Pasireotide Cmax and Ctrough

  3. assess the pharmacodynamics (PD) of pasireotide LAR

    Time frame: 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

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

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Jun 2, 2011
Registry last updated
Dec 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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