Clinical Trials Register

Summary
EudraCT Number:	2021-005238-40
Sponsor's Protocol Code Number:	EQ132-201
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2022-09-14
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2021-005238-40

A.3

Full title of the trial

A phase 2 study to evaluate the safety and efficacy of Lerociclib in participants with advanced breast cancer.

Studio di fase 2 per valutare la sicurezza e l’efficacia di Lerociclib in partecipanti con carcinoma mammario in stadio avanzato.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A study to evaluate the safety and efficacy of Lerociclib in participants with advanced breast cancer.

Studio per valutare la sicurezza e l’efficacia di lerociclib in partecipanti con carcinoma mammario in stadio avanzato.

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

EQ132-201

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT05085002

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	EQRx International, Inc.
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	EQRx Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	EQRx Inc.
B.5.2	Functional name of contact point	Clinical Operations
B.5.3	Address:
B.5.3.1	Street Address	Hampshire Street 50
B.5.3.2	Town/ city	Cambridge
B.5.3.3	Post code	MA 02139
B.5.3.4	Country	United States
B.5.4	Telephone number	0016173152255
B.5.5	Fax number	0018665006515
B.5.6	E-mail	x.x@x.x

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	LETRO-cell® 2.5 mg film-coated tablets
D.2.1.1.2	Name of the Marketing Authorisation holder	STADAPHARM GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Germany
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	LETRO-cell® 2.5 mg film-coated tablets
D.3.2	Product code	[-]
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Letrozolo
D.3.9.2	Current sponsor code	-
D.3.9.3	Other descriptive name	-
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2500
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Lerociclib
D.3.2	Product code	[EQ132, G1T38]
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Lerociclib
D.3.9.1	CAS number	2096938-59-3
D.3.9.2	Current sponsor code	-
D.3.9.3	Other descriptive name	-
D.3.9.4	EV Substance Code	SUB201851
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Fulvestrant EVER Pharma 250 mg solution for injection in pre-filled syringe
D.2.1.1.2	Name of the Marketing Authorisation holder	EVER Pharma GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Germany
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Fulvestrant 250 mg solution for injection in pre-filled syringe
D.3.2	Product code	[-]
D.3.4	Pharmaceutical form	Solution for injection in pre-filled syringe
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	FULVESTRANT
D.3.9.2	Current sponsor code	-
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	250
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 4
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Lerociclib
D.3.2	Product code	[EQ132, G1T38]
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Lerociclib
D.3.9.1	CAS number	2096938-59-3
D.3.9.2	Current sponsor code	-
D.3.9.3	Other descriptive name	-
D.3.9.4	EV Substance Code	SUB201851
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	150
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 5
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Zoladex 3.6 mg implant
D.2.1.1.2	Name of the Marketing Authorisation holder	Astrazeneca AB
D.2.1.2	Country which granted the Marketing Authorisation	Romania
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Zoladex 3.6 mg implant
D.3.2	Product code	[-]
D.3.4	Pharmaceutical form	Implant
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	GOSERELIN ACETATO
D.3.9.2	Current sponsor code	-
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	3600
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Metastatic breast cancer

Carcinoma mammario metastatico

E.1.1.1

Medical condition in easily understood language

Advanced Breast Cancer

Carcinoma mammario avanzato

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.1
E.1.2	Level	PT
E.1.2	Classification code	10055113
E.1.2	Term	Breast cancer metastatic
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10027475
E.1.2	Term	Metastatic breast cancer
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	HLT
E.1.2	Classification code	10006289
E.1.2	Term	Benign and malignant breast neoplasms
E.1.2	System Organ Class	100000004872

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	HLT
E.1.2	Classification code	10006290
E.1.2	Term	Breast and nipple neoplasms malignant
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To characterize the safety and tolerability of lerociclib in combination with endocrine therapy in participants with 1L and 2L HR+/HER2- mBC.

Caratterizzare la sicurezza e la tollerabilità di lerociclib in combinazione con la terapia endocrina in partecipanti con mBC HR+/HER2- in 1L e 2L.

E.2.2

Secondary objectives of the trial

- To investigate the efficacy of lerociclib in combination with endocrine therapy in participants with 1L and 2L HR+/HER2- mBC by line of therapy.
- To further characterize the safety and tolerability of lerociclib in combination with endocrine therapy in participants with 1L and 2L HR+/HER2- mBC.
- To assess change from baseline in global health status and qualify of life (QoL) in participants with 1L and 2L HR+/HER2- mBC by line of therapy.
- To characterize the pharmacokinetic (PK) profile of lerociclib in combination with endocrine therapy in partipcants with 1L and 2L HR+/HER2- mBC.

- Studiare, per linea di terapia, l’efficacia di lerociclib in combinazione con la terapia endocrina in partecipanti con mBC HR+/HER2- in 1L e 2L.
- Caratterizzare ulteriormente la sicurezza e la tollerabilità di lerociclib in combinazione con la terapia endocrina in partecipanti con mBC HR+/HER2- in 1L e 2L.
- Valutare, per linea di terapia, la variazione rispetto al basale dello stato di salute globale e della qualità della vita (QoL) in partecipanti con mBC HR+/HER2- di 1L e 2L.
- Caratterizzare il profilo farmacocinetico (PK) di lerociclib in combinazione con la terapia endocrina in partecipanti con mBC HR+/HER2- in 1L e 2L.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Participants are eligible to be included in the study only if all of the following criteria apply:
1. Is capable of giving signed informed consent. This includes compliance with the requirements and restrictions listed in the study informed consent form (ICF) and in this protocol.
2. Must be at least 18 years of age, or the legal age of consent in the jurisdiction in which the study is taking place, at the time of giving signed informed consent. Type of Participant and Disease Characteristics
3. Has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor-positive breast cancer by local laboratory.
4. Breast cancer is also HER2-negative and advanced (locoregionally recurrent; not amenable to curative therapy, eg, surgery and/or radiotherapy; or metastatic) and meets one of the following criteria:
• Newly diagnosed advanced/metastatic breast cancer, treatment-naïve.
• Relapsed with documented evidence of relapse following neoadjuvant (adjuvant) endocrine therapy, with no treatment for advanced/metastatic disease.
• Relapsed with documented evidence of relapse following completion of adjuvant endocrine therapy, then subsequently progressed with documented evidence of progression after one (1) line of endocrine therapy (with either tamoxifen or an AI) for advanced/metastatic disease.
• Newly diagnosed advanced/metastatic breast cancer at diagnosis that progressed with documented evidence of progression after one (1) line of endocrine therapy (with either tamoxifen, exemestane, or an AI [other than fulvestrant]).
Please refer to the Protocol for further inclusion criteria.

I partecipanti sono idonei per essere inclusi nello studio solo se soddisfano tutti i seguenti criteri:
1. Sono in grado di fornire un consenso informato firmato. Ciò include la conformità ai requisiti e alle restrizioni elencati nel modulo di consenso informato (ICF) dello studio e nel presente protocollo.
2. Devono avere almeno 18 anni di età, o l’età legale del consenso nella giurisdizione in cui si svolge lo studio, al momento del rilascio del consenso informato firmato. Tipo di partecipante e caratteristiche della malattia
3. Presentano una diagnosi confermata istologicamente e/o citologicamente di carcinoma mammario positivo per il recettore degli estrogeni e/o positivo per il recettore del progesterone da parte del laboratorio locale.
4. Il carcinoma mammario è anche HER2-negativo e avanzato (recidivante a livello locoregionale, non suscettibile di terapia curativa, ad es., intervento chirurgico e/o radioterapia o metastatico) e soddisfa uno dei seguenti criteri:
• Carcinoma mammario avanzato/metastatico di nuova diagnosi, naïve al trattamento.
• Recidiva con evidenza documentata di recidiva dopo terapia endocrina neoadiuvante (adiuvante), senza trattamento per malattia avanzata/metastatica.
• Recidiva con evidenza documentata di recidiva dopo il completamento della terapia endocrina adiuvante, successivamente progredita con evidenza documentata di progressione dopo una (1) linea di terapia endocrina (con tamoxifene o un inibitore dell’aromatasi (AI) per malattia avanzata/metastatica.
• Carcinoma mammario avanzato/metastatico di nuova diagnosi con evidenza documentata della progressione dopo una (1) linea di terapia endocrina (con tamoxifene, exemestane o un AI [diverso da fulvestrant]).
Si prega di far al protocollo per ulteriori criteri di inclusione

E.4

Principal exclusion criteria

Participants are excluded from the study if any of the following criteria apply:
Medical Conditions
1. Has symptomatic visceral disease or any disease burden that makes the participant ineligible for endocrine therapy, per the Investigator's best judgment.
2. Has peritoneal carcinomatosis.
3. Has inflammatory breast cancer at Screening.
4. Has central nervous system (CNS) involvement, unless participant is at least 4 weeks from prior therapy completion to starting study treatment, has stable CNS tumor at the time of Screening, and is not receiving steroids and/or enzyme-inducing anti-epileptic medications for brain metastases.
5. Has any clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality.
Please refer to the Protocol for further exclusion criteria.

I partecipanti sono esclusi dallo studio se soddisfano qualsiasi dei seguenti criteri:
Condizioni mediche
1. Presentano malattia viscerale sintomatica o qualsiasi carico di malattia che rende il partecipante non idoneo alla terapia endocrina, secondo il miglior giudizio dello sperimentatore.
2. Presentano carcinomatosi peritoneale.
3. Presentano carcinoma mammario infiammatorio allo screening.
4. Presentano coinvolgimento del sistema nervoso centrale (SNC), a meno che i partecipanti non abbiano almeno 4 settimane dal completamento della terapia precedente all’inizio del trattamento dello studio, presenti un tumore del SNC stabile al momento dello screening e non stia ricevendo steroidi e/o farmaci antiepilettici induttori enzimatici per le metastasi cerebrali.
5. Presentano una qualsiasi cardiopatia non controllata clinicamente significativa e/o anomalia della ripolarizzazione cardiaca.
Si prega di far al protocollo per ulteriori criteri di esclusione

E.5 End points

E.5.1

Primary end point(s)

Incidence of adverse events (AEs) and serious adverse events (SAEs).

Incidenza di eventi avversi (EA) ed eventi avversi seri (SAE).

E.5.1.1

Timepoint(s) of evaluation of this end point

The primary analysis will occur approximately 6 months after the last participant receives the first dose.

L'analisi primaria avverrà circa 6 mesi dopo che l'ultimo il partecipante riceve la prima dose.

E.5.2

Secondary end point(s)

• Objective response rate (ORR), defined as the proportion of participants with a best overall response of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) as assessed by Investigator
• Clinical benefit rate (CBR), defined as the proportion of participants with a best overall response of CR, PR, or stable disease (SD) (for at least 8 weeks) according to RECIST v1.1 as assessed by Investigator
• Progression-free survival (PFS), defined as the time from first dose of lerociclib until the date of documented progression of disease (PD) or death, according to RECIST v1.1 as assessed by Investigator
• Overall survival (OS), defined as the time from the date of first dose of lerociclib to the date of death due to any cause
• Duration of response (DOR), defined as the time from the date of first documented response until the date of confirmed PD or death, according to RECIST v1.1 as assessed by Investigator
• Time to response (TTR), defined as the time from first dose of lerociclib until the first documented response (CR or PR)
• Change from baseline in clinical laboratory parameters (hematology, clinical chemistry, coagulation, fasting lipid panel, and urinalysis)
• Change from baseline in vital signs and 12 lead electrocardiogram (ECG) parameters
• Clinically significant findings on physical examination

• Tasso di risposta obiettiva (ORR), definito come la percentuale di partecipanti con una migliore risposta complessiva di risposta completa (CR) o risposta parziale (PR) secondo la valutazione dello sperimentatore in base ai Criteri di valutazione della risposta nei tumori solidi versione 1.1 (RECIST v1.1).
• Tasso di beneficio clinico (CBR), definito come la percentuale di partecipanti con una migliore risposta complessiva di CR, PR o malattia stabile (SD) (per almeno 8 settimane) secondo la valutazione dello sperimentatore in base ai RECIST v1.1.
• Sopravvivenza libera da progressione (PFS), definita come l’intervallo di tempo dalla prima dose di lerociclib fino alla data di progressione della malattia (PD) documentata o al decesso, secondo la valutazione dello sperimentatore in base ai RECIST v1.1.
• Sopravvivenza complessiva (OS), definita come l’intervallo di tempo dalla data della prima dose di lerociclib alla data del decesso per qualsiasi causa.
• Durata della risposta (DOR), definita come l’intervallo di tempo dalla data della prima risposta documentata fino alla data di PD confermata o al decesso, secondo la valutazione dello sperimentatore in base ai RECIST v1.1.
• Variazione rispetto al basale dei parametri clinici di laboratorio (ematologia, chimica clinica, coagulazione, pannello lipidico a digiuno e analisi delle urine)
• Variazioni rispetto al basale dei parametri vitali e dei parametri degli elettrocardiogrammi (ECG) a 12 derivazioni
• Risultati clinicamente significativi all’esame obiettivo

E.5.2.1

Timepoint(s) of evaluation of this end point

For time-point(s) see section E.5.1

Per il tempo/i di si prega di fare riferimento alla sezione E.5.1

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Tolerability, Patient-reported outcome (PRO)

Tollerabilità, esito riportato dal paziente (PRO)

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Mexico

United States

Italy

Belgium

Georgia

Moldova, Republic of

Ukraine

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

100

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Participants who have completed all scheduled clinical study visits and continue to show benefit from lerociclib will be eligible to participate in a rollover study for continued access to lerociclib.

I partecipanti che hanno completato tutte le visite dello studio clinico programmate e continuano a mostrare beneficio da lerociclib saranno idonei a partecipare allo studio di rollover per l’accesso continuo a lerociclib.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2022-11-03

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-09-16

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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