Trials Sponsors Conditions Drugs Pricing

Conditions

Locally advanced or unresectable PIK3CA and/or PTENaltered metaplastic HR-positive/HER2-negative breast cancer Locally advanced or unresectable PIK3CA and/or PTENaltered metaplastic or non-metaplastic triple negative breast cancer.Advanced Breast Cancer Breast Cancer Metastatic Breast Cancer

Keywords

Breast cancerMEN1611Eribulin

Outcome Measures

Primary Outcomes (1)

To assess the efficacy of MEN1611 in combination with eribulin as determined by the clinical benefit rate (CBR).
CBR, defined as the percentage of patients who experience a complete response (CR), partial response (PR) or stable disease (SD) for at least 12 weeks after the start of MEN1611 in combination with eribulin treatment, as determined locally by the investigator per RECIST v1.1 criteria.
Baseline up to at least 12 weeks

Secondary Outcomes (6)

To determine the efficacy of MEN1611 in combination with eribulin defined as ORR of patients.
Baseline up to 24 months
To determine the efficacy of MEN1611 in combination with eribulin defined as Time To Response (TTR).
Baseline up to 24 months

Study Arms (1)

Cohort A

EXPERIMENTAL

MEN1611 orally (PO) 48 mg twice daily (BID) (2 intakes of 3x16 mg capsules, for a total daily dose of 96 mg MEN1611 free-base) during each 21-day cycle combined with eribulin mesylate 1.4 mg/m2 (equivalent to eribulin 1.23 mg/m2 when expressed as a free base) administered intravenously (IV) over 2 to 5 minutes on days 1 and 8 of every 21-day cycle (CXD1 and CXD8). A run-in phase for safety and tolerability of MEN1611 in combination with eribulin will be conducted after the first 2 cycles on the first 3 patients. Upon Steering Committee agreement the cohort A will be expanded up to N=14 (11 additional patients). Patients will receive treatment until disease progression, unacceptable toxicity, death, discontinuation from the study treatment for any other reason, withdrawal of consent, or study termination.

Drug: MEN1611Drug: Eribulin

Interventions

MEN1611Drug

MEN1611 is a potent, orally bioavailable selective inhibitor of the class I phosphatidylinositol-4,5-bisphosphate 3-kinase (PI3K) with a novel structure which exhibits a strong inhibitory activity especially against the PI3K catalytic subunit alpha (PIK3CA), with potential antineoplastic activity. PI3K alpha inhibitor MEN1611 selectively binds to and inhibits PIK3CA and its mutated forms in the PI3K/Akt (protein kinase B)/mammalian target of rapamycin (mTOR) pathway.

Cohort A

EribulinDrug

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
HALAVEN 0.44 mg/ml solution for injection
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry record

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

HALAVEN 0.44 mg/ml solution for injection
Named ingredient: eribulin
View registry record

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

PRE-SCREENING PHASE
The following criteria must be met to be eligible to entry into the pre-screening:

Sponsors & Collaborators

Medica Scientia Innovation Research S.L.
Industrylead
Menarini Group
Industrycollaborator
MedSIR

Study Sites (13)

Hospital Universitario Clínico San Cecilio de Granada

Granada, Andalusia, 18016, Spain

Hospital Universitario Virgen del Rocio

Seville, Andalusia, 41013, Spain

Onkologikoa

Donostia / San Sebastian, Basque Country, 20014, Spain

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

Centro Oncológico de Galicia

A Coruña, Galicia, 15009, Spain

Hospital Universitario de Torrejón

Torrejón de Ardoz, Madrid, 28850, Spain

CHUVI - Complejo Hospitalario Universitario de Vigo

MeSH Terms

Conditions

Breast Neoplasms

Interventions

eribulin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

José Pérez, MD
Institute of Breast Cancer, Quirón Group, Barcelona (Spain)
PRINCIPAL INVESTIGATOR
Antonio Llombart-Cussac, MD
Arnau de Vilanova Hospital, Valencia (Spain)
PRINCIPAL INVESTIGATOR

Enrollment

14 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 30, 2023

First Posted

April 12, 2023

Study Start

May 24, 2023

Actual (reported)

You may not qualify if:

Any patient meeting ANY of the following criteria will be excluded from the Study:
Current participation in another therapeutic clinical trial.
Extra-cranial radiotherapy or limited-field palliative radiotherapy within 7 days prior to Study enrolment, or patients who have not recovered from radiotherapy-related toxicities to baseline or grade ≤ 1 and/or from whom ≥ 25% of the bone marrow has been previously irradiated.
Major surgery (defined as requiring general anesthesia) or significant traumatic injury within 21 days of start of Study drug, or patients who have not recovered from the side effects of any major surgery.
Patient with a concurrent malignancy or malignancy within 5 years of Study enrollment except for carcinoma in situ of the cervix, non-melanoma skin carcinoma, or stage I uterine cancer.
Note: For other cancers considered to have a low risk of recurrence, discussion with the Medical Monitor is required.
Treatment with approved chemotherapy/immunotherapy/ targeted agents within 21 days prior to initiation of Study, or treatment with an investigational cancer therapy for 21 days or 5 half-lives (whichever is longer) prior to initiation of any Study treatment.
Patient with cerebrovascular accident or transient ischemic attack within 6 months prior to the start of any Study treatment.
Congenital long QT syndrome or screening QT interval corrected using Fridericia's formula (QTcF) \> 480 milliseconds.
Patient with an active cardiac disease or a history of cardiac dysfunction or conduction abnormalities including any of the following:
Unstable angina pectoris or documented myocardial infarction within 6 months prior to Study entry.
Symptomatic pericarditis.
Documented congestive heart failure (New York Heart Association functional classification III- IV).
Left ventricular ejection fraction (LVEF) \< 50% as determined by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO).
Ventricular arrhythmias except for benign premature ventricular contractions.
+15 more criteria

PIK3CA/PTEN-altered Advanced Breast Cancer Treated With MEN1611 Monotherapy or in Combination With Eribulin

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (1)

Cohort A

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (13)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source records

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (1)

Cohort A

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (13)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source records

Locations