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Trial record 2 of 35 for:    Lanreotide | Neuroendocrine Tumors

A Study to Evaluate Patient Experience in the Therapy of Neuroendocrine Tumors Treated With Octreotide Long Acting Release Versus Lanreotide

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ClinicalTrials.gov Identifier: NCT03289741
Recruitment Status : Recruiting
First Posted : September 21, 2017
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date  ICMJE September 19, 2017
First Posted Date  ICMJE September 21, 2017
Last Update Posted Date April 25, 2019
Actual Study Start Date  ICMJE September 19, 2017
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 20, 2017)
Comparison of mean pain scores [ Time Frame: 2 years ]
Patients will rate, on a numeric scale of 0 to 10, with 0 being No pain" to 10 being "Worst pain ever" the pain or discomfort experienced with the SSA injection.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03289741 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate Patient Experience in the Therapy of Neuroendocrine Tumors Treated With Octreotide Long Acting Release Versus Lanreotide
Official Title  ICMJE A Pilot Study To Evaluate Patient Experience With the Somatostatin Analogs Octreotide Long Acting Release and Lanreotide During the Treatment of Advanced, Nonfunctional, Well Differentiated Neuroendocrine Tumors
Brief Summary This study is being done to evaluate differences in patient experience during treatment with octreotide LAR and lanreotide.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Two-arm randomized design
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neuroendocrine Tumors
Intervention  ICMJE
  • Drug: Octreotide
    Patients will receive three monthly injections every 28 (+/- 3) days. Octreotide LAR for 3 injections followed by lanreotide for 3 injections
  • Drug: LAR Lanreotide
    Patients will receive three monthly injections every 28 (+/- 3) days. Lanreotide for 3 injections followed by octreotide LAR for 3 injections
  • Behavioral: Questionnaires
    Baseline questionnaire, Post-treatment questionnaire (after the first 3 injections), Preference questionnaire and Pain Score Diary.
Study Arms  ICMJE
  • Experimental: Octreotide then Lanreotide
    Each patient on study will receive three injections of intramuscular (IM) octreotide Long Acting Release (LAR). Octreotide LAR for 3 injections followed by lanreotide for 3 injections
    Interventions:
    • Drug: Octreotide
    • Drug: LAR Lanreotide
    • Behavioral: Questionnaires
  • Experimental: Lanreotide then Octreotide
    Each patient on study will receive three injections of deep subcutaneous (subq) lanreotide. Lanreotide for 3 injections followed by octreotide LAR for 3 injections
    Interventions:
    • Drug: Octreotide
    • Drug: LAR Lanreotide
    • Behavioral: Questionnaires
Publications * Not Provided

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 20, 2017)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Willing and able to provide written informed consent for the trial
  • ≥ 18 years of age
  • Histologically- or cytologically- confirmed locally advanced or metastatic WDNET
  • SSA therapy is recommended by physician for disease management, and has not yet begun
  • ECOG performance status of 0, 1, or 2

Exclusion Criteria:

  • Currently participating in a study of an investigational agent
  • Prior chemotherapy, targeted small molecule therapy within 2 weeks prior to study Day 1 or not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent

    *Note: Subjects with ≤ Grade 2 neuropathy or ≤ Grade 2 alopecia are an exception to this criterion and may qualify for the study

  • No concurrent chemotherapy or targeted small molecule therapy
  • If received major surgery, not recovered adequately from the toxicity and/or complications from the intervention prior to starting the study
  • Known additional malignancy that is progressing or requires active treatment
  • Active infection requiring systemic therapy
  • Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
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: Nitya Raj, MD 646-888-4849 rajn@mskcc.org
Contact: Leonard Saltz, MD 646-888-4286
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03289741
Other Study ID Numbers  ICMJE 17-422
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nitya Raj, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date April 2019

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