Clinical Trials Register

Summary
EudraCT Number:	2017-003019-21
Sponsor's Protocol Code Number:	IMMU-132-05
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2017-10-24
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

Spain - AEMPS

A.2

EudraCT number

2017-003019-21

A.3

Full title of the trial

An International, Multi-Center, Open-Label, Randomized, Phase III Trial of Sacituzumab Govitecan versus Treatment of Physician Choice in Patients with Metastatic Triple-Negative Breast Cancer Who Received at Least Two Prior Treatments

Estudio en fase III, internacional, multicéntrico, abierto, aleatorizado, de sacituzumab govitecan (IMMU-132) frente al tratamiento elegido por el médico en pacientes con cáncer de mama triple negativo metastásico que recibieron al menos dos tratamientos previos

A.3.1

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

A study to compare the study drug IMMU-132 with standard treatments in Metastatic Triple-Negative Breast Cancer patients Who have Received at Least Two Prior Treatments.

Un estudio para comparar el fármaco de estudio IMMU-132 con el tratamiento estándar en pacientes con cáncer de mama triple negativo metastásico que recibieron al menos dos tratamientos previos

A.4.1

Sponsor's protocol code number

IMMU-132-05

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	Immunomedics, 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	Immunomedics, 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	Immunomedics, Inc.
B.5.2	Functional name of contact point	Clinical Trial Information Desk
B.5.3	Address:
B.5.3.1	Street Address	300 The American Road
B.5.3.2	Town/ city	Morris Plains,
B.5.3.3	Post code	NJ 07950
B.5.3.4	Country	United States
B.5.5	Fax number	+353 1 246 0699
B.5.6	E-mail	dwhiteley@immunomedics.com

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	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	Sacituzumab govitecan
D.3.2	Product code	IMMU-132, hRS7-SN38
D.3.4	Pharmaceutical form	Infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	sacituzumab govitecan
D.3.9.1	CAS number	1491917-83-9
D.3.9.2	Current sponsor code	Sacituzumab Govitecan
D.3.9.3	Other descriptive name	IMMU-132, hRS7-SN38
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	200
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)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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	Yes
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	Comparator
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	Halaven
D.2.1.1.2	Name of the Marketing Authorisation holder	Eisai Europe Ltd
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Eribulin
D.3.2	Product code	L01XX41
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Eribulin
D.3.9.1	CAS number	441045-17-6
D.3.9.3	Other descriptive name	ERIBULIN MESYLATE
D.3.9.4	EV Substance Code	SUB31126
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	0.44
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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	Comparator
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	Xeloda
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Registration Limited
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	capecitabine
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	capecitabine
D.3.9.1	CAS number	154361-50-9
D.3.9.3	Other descriptive name	CAPECITABINE
D.3.9.4	EV Substance Code	SUB12474MIG
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	500
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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	Comparator
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	Gemzar
D.2.1.1.2	Name of the Marketing Authorisation holder	Fresenius Kabi Oncology Plc.
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	gemcitabine
D.3.4	Pharmaceutical form	Powder for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Gemcitabine hydrochloride
D.3.9.1	CAS number	122111-03-9
D.3.9.3	Other descriptive name	GEMCITABINE HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB02324MIG
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	38
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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	Comparator
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	Navelbine
D.2.1.1.2	Name of the Marketing Authorisation holder	PIERRE FABRE IBÉRICA, S.A.
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Vinorelbine
D.3.4	Pharmaceutical form	Concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Vinorelbine tartrate
D.3.9.1	CAS number	71486-22-1
D.3.9.4	EV Substance Code	SUB00069MIG
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	10
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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

Relapsed/Refractory Triple-Negative Breast Cancer

Cáncer de mama triple negativo metastásico resistente o recidivante

E.1.1.1

Medical condition in easily understood language

Triple-Negative breast cancer who has progressed or returned

Cáncer de mama triple negativo que ha progresado o regresado

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	20.0
E.1.2	Level	PT
E.1.2	Classification code	10075566
E.1.2	Term	Triple negative 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	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	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	PT
E.1.2	Classification code	10006198
E.1.2	Term	Breast cancer recurrent
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

The primary objective of this study is to compare the efficacy of sacituzumab govitecan to the treatment of physician’s choice (TPC) as measured by progression-free survival (PFS) in patients with metastatic TNBC previously treated with at least two systemic chemotherapy regimens.

El objetivo principal de este estudio es comparar la eficacia de sacituzumab govitecan con el tratamiento elegido por el médico (TEM) determinada por la supervivencia libre de progresión (SLP) en pacientes con CMTN metastásico tratados previamente con al menos dos pautas quimioterapéuticas sistémicas.

E.2.2

Secondary objectives of the trial

The secondary objectives of the study are to compare between the two treatment groups for:
- Overall Survival (OS)
- Independently-determined Objective Response Rate (ORR), duration of response and time to onset of response per RECIST 1.1 criteria
- Quality of life
- Safety (adverse events, safety laboratories, incidence of dose delays and dose reductions, treatment discontinuations due to adverse events)

Los objetivos secundarios del estudio son comparar entre los dos grupos de tratamiento:
- La supervivencia global (SG)
- La tasa de respuesta objetiva (TRO) determinada independientemente, la duración de la respuesta y el tiempo hasta el inicio de la respuesta según los criterios RECIST 1.1
- La calidad de vida
- La seguridad (acontecimientos adversos, análisis de seguridad, incidencia de retrasos en la administración de la dosis y reducciones de la dosis, interrupciones del tratamiento debido a acontecimientos adversos)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Female or male patients, >18 years of age, able to understand and give written informed consent.
• Histologically or cytologically confirmed TNBC per ASCO/CAP criteria, based on the most recent analyzed biopsy or other pathology specimen.
• Metastatic disease documented by CT or MRI imaging.
• Measurable disease by CT or MRI as per RECIST 1.1. Bone-only disease is not permitted.
• Brain MRI must be done for patients with brain metastasis and patient must have had stable CNS disease for at least 4 weeks
• At least 2 weeks beyond high dose systemic corticosteroids (however, low dose corticosteroids ≤ 20 mg prednisone or equivalent daily are permitted provided the dose is stable for 4 weeks).
• Refractory to or relapsed after at least two prior standard of care chemotherapy regimens for unresectable, locally advanced or metastatic breast cancer. (These regimens will qualify regardless of triple-negative status at the time they were given. There is no upper limit in the number of prior chemotherapies and earlier adjuvant or neoadjuvant therapy for more limited disease will qualify as one of the required prior regimens if the development of unresectable, locally advanced or metastatic disease occurred within a 12-month period of time after completion of chemotherapy).
• All patients must have been previously treated with a taxane regardless of disease stage (adjuvant, neoadjuvant or advanced) when it was given.
• Eligible for one of the chemotherapy options listed as TPC (Eribulin, capecitabine, gemcitabine, or vinorelbine) as per investigator assessment.
• ECOG performance score of 0 or 1.
• Adequate hematology without ongoing transfusional support (hemoglobin > 9 g/dL, ANC > 1,500 per mm3, platelets > 100,000 per mm3).
• Adequate renal and hepatic function (creatinine clearance of > 60 ml/min, may be calculated using Cockcroft-Gault equation; bilirubin ≤ 1.5 IULN, AST and ALT ≤ 3.0 x IULN or 5 x IULN if known liver metastases).
• Recovered from all toxicities to Grade 1 or less by NCI CTCAE v4.00 (except alopecia or peripheral neuropathy that may be Grade 2 or less) at the time of randomization. Patients with Grade 2 neuropathy are eligible but may not receive vinorelbine as TPC.
• Patients must have completed all prior cancer treatments at least 2 weeks prior to randomization including chemotherapy (includes also endrocrine treatment), radiotherapy and major surgery. Note: Prior antibody treatment for cancer must have been completed at least 3 weeks prior to randomization.
• Prior investigational agents are permitted, provided completion according to the timeframes above.

- Varones o mujeres, ≥ 18 años de edad, que puedan entender y otorgar el consentimiento informado por escrito.
- CMTN confirmado histológica o citológicamente conforme a los criterios ASCO/CAP, en base a la biopsia más reciente analizada u otra muestra patológica.
- Enfermedad metastásica verificada mediante TAC o RM.
- Enfermedad mensurable mediante TAC o RM conforme a los criterios RECIST 1.1. No se permite la enfermedad exclusivamente ósea.
- A los pacientes con metástasis cerebral se les debe realizar una RM del cerebro y los pacientes deben haber tenido enfermedad del SNC estable durante al menos 4 semanas.
- Al menos 2 semanas después de recibir corticoesteroides sistémicos en dosis altas (sin embargo, se permiten corticoesteroides en dosis bajas de ≤ 20 mg de prednisona o equivalente diariamente siempre que la dosis permanezca estable durante 4 semanas).
- Resistente o recidivante después de al menos dos pautas de quimioterapia de referencia previas para el cáncer de mama irresecable, localmente avanzado o metastásico (Anexo 1). (Estas pautas se tomarán en consideración con independencia del estado triple negativo en el momento en que fueron administradas. No hay un límite máximo en el número de quimioterapias previas, y el tratamiento adyuvante o neoadyuvante previo para la enfermedad más limitada se considerará como una de las pautas previas requeridas si la aparición de la enfermedad irresecable, localmente avanzada o metastásica se produjo en un periodo de 12 meses tras la finalización de la quimioterapia).
- Todos los pacientes deben haber sido tratados previamente con un taxano con independencia de la fase de la enfermedad (adyuvante, neoadyuvante o avanzada) cuando se administró.
- Aptos para una de las opciones de quimioterapia incluidas como TEM (eribulina, capecitabina, gemcitabina, o vinorelbina) según la evaluación del investigador.
- Puntuación del estado funcional de 0 o 1según el ECOG (Anexo 2).
- Una hematología adecuada sin el apoyo de transfusiones en curso (hemoglobina > 9 g/dl, RAN > 1500 por mm3, plaquetas > 100.000 por mm3).
- Funciones renal y hepática adecuadas (aclaramiento de creatinina de > 60 ml/min, puede calcularse mediante la ecuación de Cockcroft-Gault; bilirrubina ≤ 1,5 LSNI, AST y ALT ≤ 3,0 x LSNI o 5 x LSNI si hay metástasis hepáticas conocidas).
- Recuperados de todas las toxicidades a grado 1 o inferior según los CTCAA del NCI v4.00 (excepto alopecia o neuropatía periférica que pueden ser de grado 2 o inferior) en el momento de la aleatorización. Los pacientes con neuropatía de grado 2 son aptos pero no pueden recibir vinorelbina como TEM.
- Los pacientes deben haber completado todos los tratamientos antineoplásicos previos al menos 2 semanas* antes de la aleatorización, incluida la quimioterapia (también incluye el tratamiento endocrino), radioterapia y cirugía mayor. *El tratamiento previo con anticuerpos contra el cáncer debe haberse completado al menos 3 semanas antes de la aleatorización.
- Se permite el uso previo de fármacos experimentales, siempre que la finalización esté conforme con los plazos indicados anteriormente.

E.4

Principal exclusion criteria

• Women who are pregnant or lactating.
• Women of childbearing potential or fertile men unwilling to use effective contraception during study until conclusion of 4-week post-treatment evaluation period.
• Patients with Gilbert’s disease.
• Presence of bulky disease (defined as any single mass > 7 cm in its greatest dimension).
• Patients with non-melanoma skin cancer or carcinoma in situ of the cervix are eligible, while patients with other prior malignancies must have had at least a 3-year disease-free interval.
• Patients known to be HIV positive, hepatitis B positive, or hepatitis C positive.
• Known history of unstable angina, MI, or CHF present within 6 months of randomization or clinically significant cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy.
• Known history of clinically significant active COPD, or other moderate-to-severe chronic respiratory illness present within 6 months of randomization.
• Prior history of clinically significant bleeding, intestinal obstruction, or GI perforation within 6 months of randomization.
• Infection requiring antibiotic use within one week of randomization.
• Patients with a history of an anaphylactic reaction to irinotecan.
• Other concurrent medical or psychiatric conditions that, in the Investigator’s opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.

- Mujeres que estén embarazadas o en período de lactancia.
- Mujeres con capacidad para procrear o varones fértiles que no estén dispuestos a utilizar un método anticonceptivo eficaz durante el estudio hasta la conclusión del período de evaluación posterior al tratamiento de 4 semanas.
- Pacientes con la enfermedad de Gilbert.
- Presencia de neoplasia maligna con gran masa tumoral (definida como cualquier masa única > 7 cm en su dimensión máxima).
- Los pacientes con cáncer de piel no melanómico o carcinoma in situ del cuello uterino son aptos, mientras que los pacientes con otras neoplasias malignas previas deben haber tenido al menos un intervalo sin enfermedad de 3 años.
- Los pacientes que se sabe que son positivos para VIH, positivos para hepatitis B o positivos para hepatitis C.
- Antecedentes conocidos de angina de pecho inestable, IM o ICC presente en los 6 meses previos a la aleatorización o arritmia cardíaca clínicamente significativa (distinta de fibrilación auricular estable) que requiera tratamiento antiarrítmico.
- Antecedentes conocidos de EPOC activa clínicamente significativa u otra enfermedad respiratoria crónica moderada o grave en los 6 meses previos a la aleatorización.
- Antecedentes previos de hemorragia clínicamente significativa, obstrucción intestinal o perforación digestiva en los 6 meses previos a la aleatorización.
- Infección que requiera el uso de antibióticos en el plazo de una semana antes de la aleatorización.
- Pacientes con antecedentes de una reacción anafiláctica a irinotecán.
- Otras enfermedades o trastornos psiquiátricos concurrentes que, en opinión del investigador, es probable que puedan confundir la interpretación del estudio o impedir la realización de los procedimientos del estudio y los exámenes de seguimiento.

E.5 End points

E.5.1

Primary end point(s)

Progression-free survival (PFS) as determined by an independent centralized blinded assessment.

Supervivencia libre de progresión (SLP) según lo determinado por una evaluación enmascarada centralizada e independiente.

E.5.1.1

Timepoint(s) of evaluation of this end point

Monitored throughout the study

Monitorizada a lo largo del estudio

E.5.2

Secondary end point(s)

- Overall survival (OS)
- Objective response rate (ORR), duration of response, and time to onset of response
- Quality of life
- Safety, including: adverse events; safety laboratories and evaluations; incidence of dose delays and dose reductions; and treatment discontinuations due to adverse events

- La supervivencia global (SG)
- La tasa de respuesta objetiva (TRO), la duración de la respuesta y el tiempo hasta el inicio de la respuesta
- La calidad de vida
- La seguridad, incluidos: acontecimientos adversos, evaluaciones y análisis de seguridad, incidencia de retrasos en la administración de la dosis y reducciones de la dosis, e interrupciones del tratamiento a causa de los acontecimientos adversos

E.5.2.1

Timepoint(s) of evaluation of this end point

Monitored throughout the study

Monitorizada a lo largo del estudio

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

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)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

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)

Yes

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

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

Belgium

Canada

France

Germany

Ireland

Italy

Spain

United Kingdom

United States

E.8.7

Trial has a data monitoring committee

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

LPLV

UVUP

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:

263

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

175

F.4.2.2

In the whole clinical trial

328

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)

After discontinuing the study, the patient may not receive any more sacituzumab govitecan; otherwise, there is no restriction on subsequent therapies or interventions that a patient may receive.

No se permitirá el cruce al tratamiento con sacituzumab govitecan tras la interrupción del tratamiento en el grupo de TEM pero, por lo demás, no hay ninguna restricción en cuanto a los tratamientos posteriores que un paciente puede recibir después de interrumpir el estudio.

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1
G.4.1	Name of Organisation	National Institute for Health Research (NIHR)
G.4.3.4	Network Country	United Kingdom
G.4 Investigator Network to be involved in the Trial: 2
G.4.1	Name of Organisation	Cancer Trials Ireland (CTI)
G.4.3.4	Network Country	Ireland

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2017-12-27

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-12-22

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

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