Patient undergoing breast surgery with axillary lymph node dissection. MedDRA version: 15.0 Level: SOC Classification code 10005329 Term: Blood and lymphatic system disorders System Organ Class: 10005329 - Blood and lymphatic system disorders
Conditions
Interventions
Product Name: NA
Product Code: LF-PB
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: OCTREOTIDE
CAS Number: 79517-01-4
Current Sponsor code: LF-PB
Other descrip
Sponsors
CHEMI S.P.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Female aged 18 to 80 years inclusive 2.Body mass index =18 kg/m2 3.Signed informed consent form 4.Diagnosis of breast cancer (BC) 5.Undergoing breast surgery with axillary lymph node dissection Note: Collagen powder or fibrin sealant are not permitted. 6.Negative serum pregnancy test for women of childbearing potential Note: Female patients of childbearing potential should be advised to use adequate contraception if necessary during treatment with octreotide. 7.Aspartate aminotransferase and alanine aminotransferase =65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: 1. Presence of any of the following conditions: a. Previous axillary surgery b. Previous chemotherapy c. Previous neoadjuvant therapy d. Recurrent BC e. Diabetes f. Cholelithiasis g. Hypothyroidism h. Hepatitis i. Pregnant or lactating j. Human immunodeficiency virus or hepatitis B or C by screening serology 2. History of radiotherapy 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, electrocardiogram (ECG), or laboratory evaluation finding 8. Current or recurrent disease that could affect the action, absorption, or disposition of the study drug 9. Current or recurrent disease that could affect the results of the clinical or laboratory assessments required for the study 10. Corticosteroids treatment within 1 month prior to surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To assess the effect of the extended release of octreotide (LF-PB) 10 mg, 20 mg, and 30 mg on time to resolution of lymphorrhea • To evaluate safety and tolerability of LF-PB 10 mg, 20 mg, and 30 mg;Secondary Objective: • To assess the effects of LF-PB 10 mg, 20 mg, and 30 mg on the daily volume of lymph collected from the drain • To assess the effect of LF-PB 10 mg, 20 mg, and 30 mg on complications related to lymphorrhea • To evaluate the pharmacokinetic (PK) profile of LF-PB 10 mg, 20 mg, and 30 mg;Primary end point(s): Duration of lymphorrhea while the drain is in place. End of lymphorrhea will be declared when the lymph volume measured by the patient is <50 mL/day in 2 consecutive daily collections. The reduction to <50ml in two consecutive days must be confirmed by the site. The date of lymphorrhea resolution is defined as the first of the 2 consecutive days when lymph volume collected is <50 mL.;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Daily volume of lymph collected when drain is in place as reported daily by the patient Duration of lymphorrhea when lymph daily volumes >50ml persists after drain removal and lymph is collected by puncture. End of lymphorrhea will be declared when the lymph volume is <50 mL. • Time to drain removal • Percentage of responders at 1 week after surgery. A responder is a patient for whom lymphorrhea is reduced to <50 mL in 2 consecutive daily collections. • Percentage of responders at drain removal. A responder is a patient for whom lymphorrhea is reduced to <50 mL in 2 consecutive daily collections. • Number of complications related to lymphorrhea • PK parameters (Cmax,, Tmax AUC0-t, and possibly AUC0-, t1/2) after 10 mg, 20 mg, and 30 mg LF-PB IM single-dose administration;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Countries
Italy
Contacts
Public ContactSara Manzoni - Clinical R&D Dept.
Chemi S.p.A.
Outcome results
None listed