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

NCT01754285 | Completed Phase 2

• 1 other identifier: LF-PB/11/04
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 13

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.

Conditions

Lymphorrhea

Outcome Measures

Primary Outcomes (2)

• effect of LF-PB 10 mg, 20 mg, and 30 mg on time to resolution of lymphorrhea;

  End of lymphorrhea will be declared when the lymph volume measured by the patient is \< 50 ml/day in 2 consecutive days.

  12 weeks post surgery

• number of AEs and laboratory, ECG, vital sign abnormalities of LF-PB 10 mg, 20 mg, and 30 mg

  Safety and tolerability of LF-PB

  12 weeks after surgery

Secondary Outcomes (3)

• effects of LF-PB 10, 20, and 30 mg on the daily volume of lymph collected from the drain

  12 weeks after surgery

• number of complications related to lymphorrhea

  12 weeks after surgery

• PK profile (Cmax, Tmax, AUC0-t and possibly AUC0-inf and T1/2) of LF-PB 10, 20 and 30 mg

  12 weeks after surgery

Other Outcomes (1)

• correlation between LF-PB exposures and efficacy after the administration of LF-PB 10 mg, 20 mg, and 30 mg

  12 weeks after surgery

Study Arms (4)

LF-PB 10 mg

EXPERIMENTAL

2 IM injections = placebo + 10 mg

Drug: LF-PB and Placebo

LF-PB 20 mg

EXPERIMENTAL

2 IM injections = placebo + 20 mg

Drug: LF-PB and Placebo

LF-PB 30 mg

EXPERIMENTAL

2 IM injections = 10 mg + 20 mg

Drug: LF-PB

Placebo

PLACEBO COMPARATOR

2 IM injections of placebo

Drug: Placebo

Interventions

LF-PB and Placebo DRUG

Also known as: extended-release of octreotide and placebo

LF-PB 10 mg; LF-PB 20 mg

Placebo DRUG

Placebo

LF-PB DRUG

Also known as: LF-PB 10 mg and LF-PB 20 mg

LF-PB 30 mg

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female aged 18 to 80 years inclusive
• Body mass index (BMI) ≥18 kg/m2
• Signed informed consent form
• Diagnosis of BC
• Undergoing breast surgery with ALND Note: Collagen powder or fibrin sealant are not permitted.
• 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.
• AST and alanine aminotransferase ALT \<1.5 x the upper limit of normal
• Ability to fully understand all study procedures and to comply with study visits scheduled for the duration of the study.

You may not qualify if:

• Presence of any of the following conditions:
• Previous axillary surgery on the same armpit undergoing surgery in this study
• Previous chemotherapy or radiotherapy within five years from study drug administration
• Previous neoadjuvant therapy
• Recurrent BC on the same breast undergoing surgery in this study
• Diabetes
• Cholelithiasis
• 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.
• Hepatitis
• Pregnant or lactating
• Human immunodeficiency virus or hepatitis B or C by screening serology
• History of radiotherapy on the same breast or armpit undergoing surgery in this study.
• History of anaphylaxis to study drug
• Ascertained or presumptive hypersensitivity to the active principle and/or the ingredients of the study drug formulation
• QTc interval extension at screening or baseline \> 450 msec (as the mean of 3 consecutive readings 5 minutes apart)

Sponsors & Collaborators

• Chemi S.p.A.: lead

Study Sites (13)

Humanitas Centro Catanese di Oncologia Dipartimento di Oncologia -Chirurgia Oncologica Generale

Via V.E. Dabormida, 64, Catania, 95125, Italy

Location

Fondazione per la Ricerca e la Cura dei Tumori "Tommaso Campanella" Unità Operativa Complessa CRR per il Counselling Genetico e le Terapie Innovative in Oncologia Medica

Viale Europa-Loc. Germaneto, Catanzaro, 88100, Italy

Location

Azienda Ospedaliera OIRM Sant'Anna Dipartimento Funzionale di Oncologia - Breast Unit

Corso Spezia, 60 Torino, 10126, Italy

Location

IRCCS Azienda Ospedaliero Universitaria San Martino di Genova - IST Genova Dipartimento Chirurgia Ospedaliera - Semeiotica Chirurgica e Chirurgia Senologica

L.go Rosanna Benzi,10 Genova, 16132, Italy

Location

Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari Chirurgia Generale Universitaria "G.Marinaccio"

Piazza Giulio Cesare 11 Bari, 70124, Italy

Location

Azienda Ospedaliero-Universitaria Di Pisa

Pisa, 56123, Italy

Location

Universita' Campus Bio-medico di Roma

Roma, 00128, Italy

Location

Ospedale Casa Sollievo della Sofferenza - Istituto di Ricovero e Cura a Carattere Scientifico Opera di San Pio da Pietrelcina

San Giovanni Rotondo, 71013, Italy

Location

Fondazione del Piemonte per l'Oncologia - IRCC Candiolo D.O. di Ginecologia Oncologica

Strada Provinciale 142 Km 3.95- Candiolo, 10060, Italy

Location

Azienda Ospedaliero-Universitaria di Parma Dipartimento Clinica Chirurgica e Terapia Chirurgica

Via Gramsci, 14 Parma, 43126, Italy

Location

IRCCS Istituto Nazionale per lo Studio e la Cura dei Tumori, Fondazione Giovanni Pascale Dipartimento di Senologia - Struttura Complessa Oncologia Medica Senologica

Via Mariano Semmola Napoli, 80131, Italy

Location

Azienda Ospedaliero Universitaria Policlinico di Modena Unità Semplice di Senologia

Via Pozzo 71, Modena, 41124, Italy

Location

Azienda Ospedaliero Universitaria di Ferrara c/o Ospedale di Cona Sezione di Clinica Chirurgica

Vial Aldo Moro 8, Cona-Ferrara, 44124, Italy

Location

Study Officials

• Paolo Carcoforo, MD

  Clinica Chirurgica, Azienda Ospedaliero-Universitaria Arcispedale "S. Anna" Ferrara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2012
• First Posted: December 21, 2012
• Study Start: November 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: July 29, 2014

Record last verified: 2014-07

Locations

IT (13)