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

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

Tracking Information

• First Submitted Date: December 12, 2012
• First Posted Date: December 21, 2012
• Last Update Posted Date: July 29, 2014
• Study Start Date: November 2012
• Actual Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: 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: Extended-release of Octreotide (LF-PB) for the Treatment of Lymphorrhea
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Lymphorrhea

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 28, 2014): 114
• Original Estimated Enrollment (submitted: December 18, 2012): 120
• Actual Study Completion Date: May 2014
• Actual Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: Female

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT01754285
• Other Study ID Numbers: LF-PB/11/04
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Chemi S.p.A.
• Study Sponsor: Chemi S.p.A.
• Collaborators: Not Provided

Investigators

• Principal Investigator: Paolo Carcoforo, MD; Clinica Chirurgica, Azienda Ospedaliero-Universitaria Arcispedale "S. Anna" Ferrara

• PRS Account: Chemi S.p.A.
• Verification Date: July 2014