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Extended-release of Octreotide (LF-PB) for the Treatment of Lymphorrhea

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ClinicalTrials.gov Identifier: NCT01754285
Recruitment Status : Completed
First Posted : December 21, 2012
Last Update Posted : July 29, 2014
Sponsor:
Information provided by (Responsible Party):
Chemi S.p.A.

Tracking Information
First Submitted Date  ICMJE December 12, 2012
First Posted Date  ICMJE December 21, 2012
Last Update Posted Date July 29, 2014
Study Start Date  ICMJE November 2012
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2012)
  • effect of LF-PB 10 mg, 20 mg, and 30 mg on time to resolution of lymphorrhea; [ Time Frame: 12 weeks post surgery ]
    End of lymphorrhea will be declared when the lymph volume measured by the patient is < 50 ml/day in 2 consecutive days.
  • number of AEs and laboratory, ECG, vital sign abnormalities of LF-PB 10 mg, 20 mg, and 30 mg [ Time Frame: 12 weeks after surgery ]
    Safety and tolerability of LF-PB
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2012)
  • effects of LF-PB 10, 20, and 30 mg on the daily volume of lymph collected from the drain [ Time Frame: 12 weeks after surgery ]
    daily volume of lymph collected from the drain
  • number of complications related to lymphorrhea [ Time Frame: 12 weeks after surgery ]
    effect of LF-PB 10, 20 and 30 mg on complications related to lymphorrhea
  • PK profile (Cmax, Tmax, AUC0-t and possibly AUC0-inf and T1/2) of LF-PB 10, 20 and 30 mg [ Time Frame: 12 weeks after surgery ]
    PK parameters
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 18, 2012)
correlation between LF-PB exposures and efficacy after the administration of LF-PB 10 mg, 20 mg, and 30 mg [ Time Frame: 12 weeks after surgery ]
correlation between exposure of the drug and efficacy
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Extended-release of Octreotide (LF-PB) for the Treatment of Lymphorrhea
Official Title  ICMJE A Randomized, Double-Blind, Double Dummy, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy of LF-PB 10 mg, 20 mg, and 30 mg to Treat Lymphorrhea Post Axillary Dissection in Breast Cancer
Brief Summary

This is a phase II, multicenter, double-blind, double-dummy, parallel-group, placebo-controlled, study to evaluate LF-PB versus placebo in female patients with brest cancer who are undergoing breast surgery with axillary lymphnode dissection.

Recruited patients will be randomly assigned to one of the following treatment groups: Placebo, LF-PB 10 mg, LF-PB 20 mg and LF-PB 30 mg.

Mode of administration is single intramuscular (IM) injection so the treatments arms are as follows:

Placebo: 2 injections of placebo LF-PB 10 mg: 2 injections = placebo + 10 mg LF-PB 20 mg: 2 injections = placebo + 20 mg LF-PB 30 mg: 2 injections = 10 mg + 20 mg

The study will randomize a total of 120 patients (30 per arm) in about 10 Italian Sites.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Lymphorrhea
Intervention  ICMJE
  • Drug: LF-PB and Placebo
    Other Name: extended-release of octreotide and placebo
  • Drug: Placebo
  • Drug: LF-PB
    Other Name: LF-PB 10 mg and LF-PB 20 mg
Study Arms  ICMJE
  • Experimental: LF-PB 10 mg
    2 IM injections = placebo + 10 mg
    Intervention: Drug: LF-PB and Placebo
  • Experimental: LF-PB 20 mg
    2 IM injections = placebo + 20 mg
    Intervention: Drug: LF-PB and Placebo
  • Experimental: LF-PB 30 mg
    2 IM injections = 10 mg + 20 mg
    Intervention: Drug: LF-PB
  • Placebo Comparator: Placebo
    2 IM injections of placebo
    Intervention: Drug: Placebo
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 Completed
Actual Enrollment  ICMJE
 (submitted: July 28, 2014)
114
Original Estimated Enrollment  ICMJE
 (submitted: December 18, 2012)
120
Actual Study Completion Date  ICMJE May 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Female aged 18 to 80 years inclusive
  2. Body mass index (BMI) ≥18 kg/m2
  3. Signed informed consent form
  4. Diagnosis of BC
  5. Undergoing breast surgery with ALND Note: Collagen powder or fibrin sealant are not permitted.
  6. Negative serum pregnancy test for women of childbearing potential Note: Female patients of child-bearing potential should be advised to use adequate contraception if necessary during treatment with octreotide.
  7. AST and alanine aminotransferase ALT <1.5 x the upper limit of normal
  8. Ability to fully understand all study procedures and to comply with study visits scheduled for the duration of the study.

Exclusion Criteria:

  1. Presence of any of the following conditions:

    1. Previous axillary surgery on the same armpit undergoing surgery in this study
    2. Previous chemotherapy or radiotherapy within five years from study drug administration
    3. Previous neoadjuvant therapy
    4. Recurrent BC on the same breast undergoing surgery in this study
    5. Diabetes
    6. Cholelithiasis
    7. Hypothyroidism. If patient is being administered Euritox/ Levothyroxine (or analogues) and levels of T3, T4 and TSH are confirmed to be within the normal ranges at screening, the patient can be enrolled in this study.
    8. Hepatitis
    9. Pregnant or lactating
    10. Human immunodeficiency virus or hepatitis B or C by screening serology
  2. History of radiotherapy on the same breast or armpit undergoing surgery in this study.
  3. History of anaphylaxis to study drug
  4. Ascertained or presumptive hypersensitivity to the active principle and/or the ingredients of the study drug formulation
  5. QTc interval extension at screening or baseline > 450 msec (as the mean of 3 consecutive readings 5 minutes apart)
  6. Presence of any disease or use of concomitant medication known to increase the QT interval (see Appendix 2 for a list of such compounds)
  7. Clinically significant or relevant abnormal medical history, vital sign, physical examination, ECG, or laboratory evaluation finding
  8. Current or recurrent disease that could affect the results of the clinical or laboratory assessments required for the study
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 80 Years   (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 Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01754285
Other Study ID Numbers  ICMJE LF-PB/11/04
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chemi S.p.A.
Study Sponsor  ICMJE Chemi S.p.A.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Paolo Carcoforo, MD Clinica Chirurgica, Azienda Ospedaliero-Universitaria Arcispedale "S. Anna" Ferrara
PRS Account Chemi S.p.A.
Verification Date July 2014

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