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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03767335
Other study ID # MEN1611-01
Secondary ID 2017-004631-36
Status Completed
Phase Phase 1
First received
Last updated
Start date July 19, 2018
Est. completion date February 23, 2024

Study information

Verified date May 2024
Source Menarini Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main purpose of this open-label, dose-escalation, phase Ib study is to identify the appropriate dose of MEN1611 to be used in combination with Trastuzumab with/without Fulvestrant for the treatment of advanced or metastatic HER2-positive breast cancer


Description:

This Phase Ib study will investigate the safety and anti-tumor activity of daily oral doses MEN1611 in combination with Trastuzumab with/without Fulvestrant in female and male patients affected by advanced or metastatic HER2-positive breast cancer. Fulvestrant will be added to the post-menopausal patients with hormone-sensitive disease. MEN1611 is an investigational drug which blocks a protein called PI3K (phosphoinositide 3-kinase) involved in cancer cells growth. The Maximum Tolerated Dose (MTD) of MEN1611 given as single agent was assessed in a phase I trial in patients with advanced solid tumors. This Phase IB will start with a dose escalation part (Step 1) to identify the MTD of MEN1611 given in combination with Trastuzumab with/without Fulvestrant. The study will continue with a cohort expansion (Step 2) to investigate the anti-tumor activity of the selected MEN1611 dose level considered to be tolerable by a Safety Review Committee.


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date February 23, 2024
Est. primary completion date January 22, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Main Inclusion Criteria: - Histologically confirmed invasive adenocarcinoma of the breast - Known HER2+ breast cancer - Advanced or metastatic breast cancer harbouring PIK3CA mutation on tissue sample - > 2 lines of anti-HER2 based regimens with at least 1 regimen with trastuzumab - Radiological documented evidence of progressive disease - Life expectancy = 12 weeks - Eastern Cooperative Oncology Group (ECOG) performance status = 2 Main Exclusion Criteria: - Previous treatment with PI3K inhibitors - Brain metastases untreated, unless treated > 4 weeks and only if clinically stable and not receiving corticosteroids - History of clinically significant bowel disease - = grade 2 diarrhoea - History of significant, uncontrolled, or active cardiovascular disease - Any serious and/or unstable pre-existing psychiatric or neurologic illness or other conditions that could interfere with patient's safety - Not controlled diabetes mellitus (glycated haemoglobin [HbA1c] >7%) and fasting plasma glucose >126 mg/dL - Concurrent chronic treatment with steroids, as immunosuppressant, or another immunosuppressive agent

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
MEN1611
MEN1611 oral dose administered twice daily for a continuous 28-day cycle
Trastuzumab
Trastuzumab solution for infusion administered weekly via IV
Fulvestrant
Fulvestrant solution for injection administered monthly via IM (only for HR-positive postmenopausal women)

Locations

Country Name City State
Belgium Cliniques Universitaires Saint-Luc Brussels
Belgium Institut Jules Bordet Brussels
Belgium UZ Leuven Leuven
France Centre Georges François Leclerc Dijon
France Centre Oscar Lambret Lille Cedex
France Institut Régional du Cancer de Montpellier Montferrier Sur Lez
France ICO - Site René Gauducheau Saint-Herblain
France Institut Claudius Regaud Oncopole Toulouse
France Institut Gustave Roussy Villejuif cedex
Italy Azienda Ospedaliero Universitaria Mater Domini Catanzaro
Italy Istituto Clinico Humanitas Milan
Italy Istituto Europeo di Oncologia (IEO) Milan
Italy Ospedale San Raffaele Milan
Spain Hospital Clínic i Provincial de Barcelona Barcelona
Spain Hospital Universitari Vall d'Hebron Barcelona
Spain Centro Integral Oncologico Clara Campal Madrid
Spain Hospital General Universitario Gregorio Marañon Madrid
Spain START Madrid Fundacion Jimenez Diaz Madrid
Spain Hospital Clínico Universitario Virgen de la Victoria Málaga
Spain Hospital Universitario Virgen del Rocío Sevilla
United Kingdom Velindre Cancer Centre Cardiff
United Kingdom Sarah Cannon Research Institute UK London
United Kingdom University College London Hospitals London
United Kingdom The Christie Manchester
United States Detroit Clinical Research Center Farmington Hills Michigan
United States Holy Cross Hospital Inc. Fort Lauderdale Florida
United States Washington University Saint Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
Menarini Group

Countries where clinical trial is conducted

United States,  Belgium,  France,  Italy,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum Tolerated Dose (MTD) and Recommended Phase 2 dose (RP2D) 28 Days
Secondary Treatment emergent adverse events (TEAEs) 2 years
Secondary Progression Free Survival 2 years
Secondary Overall Survival 2 years
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