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Trial record 81 of 2812 for:    Neoplasms, Germ Cell and Embryonal | Neuroendocrine Tumors

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

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ClinicalTrials.gov Identifier: NCT01364415
Recruitment Status : Completed
First Posted : June 2, 2011
Last Update Posted : June 28, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE May 18, 2011
First Posted Date  ICMJE June 2, 2011
Last Update Posted Date June 28, 2016
Study Start Date  ICMJE August 2011
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2011)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01364415 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2011)
  • 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
  • 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
  • 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
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dose Escalation Study of Pasireotide (SOM230) in Patients With Advanced Neuroendocrine Tumors (NETs)
Official Title  ICMJE A Phase I, Multi-center, Open-label, Dose Escalation Study of Pasireotide (SOM230) LAR in Patients With Advanced Neuroendocrine Tumors (NETs)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neuroendocrine Tumors
Intervention  ICMJE Drug: Pasireotide LAR
Other Name: SOM230
Study Arms  ICMJE Experimental: Pasireotide LAR
Intervention: Drug: Pasireotide LAR
Publications * Yao JC, Chan JA, Mita AC, Kundu MG, Hermosillo Reséndiz 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 13, 2015)
29
Original Estimated Enrollment  ICMJE
 (submitted: June 1, 2011)
42
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01364415
Other Study ID Numbers  ICMJE CSOM230D2101
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP