Clinical Trials Register

Summary
EudraCT Number:	2017-002808-28
Sponsor's Protocol Code Number:	OZM-061
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2017-10-20
Trial 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

2017-002808-28

A.3

Full title of the trial

Olala Trial: A Retrospective/Prospective Analysis of Characterization of the Long-Term Responders on Olaparib in Solid Tumours

Olala: Análisis retrospectivo/prospectivo de caracterización de pacientes que responden a largo plazo al tratamiento con olaparib en tumores sólidos

A.3.1

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

A study to examine the characteristics of patients with solid tumors who have long-term benefit from Olaparib

Un ensayo para examinar las caracteristicas de pacientes con tumores solidos que obtienen beneficio a largo plazo con Olaparib

A.3.2

Name or abbreviated title of the trial where available

Olala

A.4.1

Sponsor's protocol code number

OZM-061

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT02489058

A.5.4

Other Identifiers

Name:

SMS-protocol code

Number:

SMS-0389

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	Princess Margaret Cancer Centre
B.1.3.4	Country	Canada
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Astra Zeneca
B.4.2	Country	Sweden
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	SMS-oncology
B.5.2	Functional name of contact point	Miranda Kleijn
B.5.3	Address:
B.5.3.1	Street Address	1098XH
B.5.3.2	Town/ city	Amsterdam
B.5.3.3	Post code	1098XH
B.5.3.4	Country	Netherlands
B.5.4	Telephone number	310204350580
B.5.5	Fax number	310204350589
B.5.6	E-mail	regulatory@sms-oncology.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	Yes
D.2.1.1.1	Trade name	Lynparza (olaparib)
D.2.1.1.2	Name of the Marketing Authorisation holder	AstraZeneca AB
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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.3.4	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	Olaparib
D.3.9.1	CAS number	763113-22-0
D.3.9.3	Other descriptive name	OLAPARIB
D.3.9.4	EV Substance Code	SUB32234
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	800
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

epithelial ovarian cancer (including fallopian tube or peritoneal cancer)

cancer de ovario

E.1.1.1

Medical condition in easily understood language

tumor of the ovary

tumor de ovario

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	10061328
E.1.2	Term	Ovarian epithelial cancer
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 clinically, molecularly and genomically characterize patients with long term and short term disease control on olaparib in terms of:
• Somatic BRCA mutation
• Homologous recombination repair (HRR) deficiency panel
• Genomic sequencing
• Immune profile
• PI3K/Akt pathway expression
• Gene expression

Caracterizar clínica, molecular y genómicamente a las pacientes con un control de la enfermedad a largo y corto plazo con olaparib en términos de lo siguiente:
• Mutación de BRCA somática
• Panel de deficiencia de reparación de recombinación homóloga (HRR)
• Secuenciación genómica
• Perfil inmunológico
• Expresión de la vía PI3K/Akt
• Expresión genética

E.2.2

Secondary objectives of the trial

• To define the HRR deficiency profile
• Define the level of poly (ADP-ribose) (PAR) expression by immunohistochemistry
• To compare the signature of PARP response with the signature of platinum sensitivity which have been previously assessed in patients with long response to platinum based chemotherapy
• To assess the signature of PARP response and PARP resistance on different tumour sites
• To define how patients take olaparib in the long term setting

Exploratory objectives:
• To characterize the tumor profile at disease progression
• To assess the pharmacokinetics and pharmacogenomics of olaparib for patients still on treatment
• To assess circulating tumor DNA (ctDNA) at the time of response on olaparib and at progression

• Definir el perfil de déficit de HRR
• Definir el nivel de expresión de poli ADP ribosa (PAR) mediante inmunohistoquímica
• Comparar la firma de la respuesta de PARP con la firma de la sensibilidad de platino que se haya evaluado previamente en pacientes con una larga respuesta a quimioterapia basada en platino
• Evaluar la firma de la respuesta de PARP y la resistencia a PARP en distintos sitios de tumores
• Definir cómo los pacientes toman olaparib a largo plazo

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

To characterize the tumor profile at disease progression. Part of main protocol.

Caracterizar el perfil del tumor en la progresión de la enfermedad. Parte del protocolo

E.3

Principal inclusion criteria

Inclusion Criteria:
1. Previous or current treatment with Olaparib in a clinical trial/standard of care that included one of the following as a first step study for epithelial ovarian cancer (including fallopian tube or peritoneal cancer) :
• single agent olaparib given for relapsed disease
or
• single agent olaparib given as maintenance therapy after response to platinum based chemotherapy
or
• olaparib combined with platinum based chemotherapy and then continued as maintenance therapy
or
• olaparib combined with other types of therapy
2. Had a durable response to Olaparib defined as patients who have benefited from olaparib for ≥ 2 years.
or
The control group is patients who had a short duration benefit with Olaparib of less than 3 months in any individual clinical trial/standard of care
3. Ability to understand and the willingness to sign a written informed consent document.
4. Subject is willing and able to comply with scheduled visits, laboratory tests, and other study procedures

1. Tratamiento previo o actual con olaparib en un ensayo clínico o estándar de atención médica que haya incluido uno de los tratamientos siguientes como ensayo primario para el cáncer epitelial de ovario (incluido el cáncer de trompas de Falopio o peritoneal):

• olaparib como único agente administrado para enfermedad recidivante
o bien
• olaparib como único agente administrado como tratamiento de mantenimiento después de la respuesta a quimioterapia basada en platino
o bien
• olaparib combinado con quimioterapia basada en platino y continuado como tratamiento de mantenimiento
o bien
• olaparib combinado con otros tipos de tratamiento

2. Personas con una respuesta duradera a olaparib, es decir, pacientes que han obtenido beneficios de olaparib durante ≥ 18 meses

o bien

El grupo de control consta de pacientes que han obtenido beneficios de corta duración con olaparib de menos de 6 meses, en un ensayo clínico o estándar de atención médica individual.

3. Capacidad para entender y voluntad para firmar un documento de consentimiento informado.

4. Voluntad y capacidad de la paciente para cumplir con las visitas programadas, las pruebas de laboratorio y otros procedimientos del estudio.

E.4

Principal exclusion criteria

Exclusion Criteria:
1. Any severe acute or chronic medical or psychiatric condition or laboratory abnormality that would render the patient unsuitable for biopsy
2. Pregnant or breastfeeding women

1. Cualquier trastorno médico o psiquiátrico grave, agudo o crónico, o anomalía de laboratorio que puedan hacer que el paciente no sea apto para una biopsia
2. Mujeres embarazadas o en período de lactancia

E.5 End points

E.5.1

Primary end point(s)

To clinically, molecularly and genomically characterize patients with long term and short term disease control on olaparib in terms of:
- Somatic BRCA mutation
- Homologous recombination repair (HRR) deficiency panel
- Genomic Sequencing
- Immune Profile
- PI3K/Akt pathway expression
- Gene expression

E.5.1.1

Timepoint(s) of evaluation of this end point

Estimated primary completion date: July 2019

Julio 2019 (estimado)

E.5.2

Secondary end point(s)

- To define the HRR deficiency profile
- Define the level of poly (ADP-ribose) (PAR) expression by immunohistochemistry
- To compare the signature of PARP response with the signature of platinum sensitivity which have been previously assessed in patient with long response to platinum based chemotherapy
- To assess the signature of PARP response and PARP resistance on different tumour sites
- To define how patient take olaparib in the long term setting

Exploratory Endpoints
- To characterize the tumor profile at disease progression
- To assess the pharmacokinetics and pharmacogenomics of olaparib for patients still on treatment
- To assess circulating tumor DNA (ctDNA) at the time of response on olaparib and at progression

E.5.2.1

Timepoint(s) of evaluation of this end point

Estimated primary completion date: July 2019

Julio 2019 (estimado)

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

E.6.4

Safety

E.6.5

Efficacy

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Prognosis

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)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

E.8.1.2

Open

Yes

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

Yes

E.8.1.7.1

Other trial design description

retrospectivo/prospectivo

retrospective/prospective

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

Yes

E.8.2.3.1

Comparator description

pacientes con beneficio a corto plazo con Olaparib o que estan en tratamiento menos de 3 meses

patients who had a short duration benefit with Olaparib or are in treatment less than 3 months

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the 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

Canada

Italy

Spain

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

End of trial projected to be 4 years after initiation in July 2015 in Canada. This is a study involving patients from several clinical trials who had received olaparib. Sample size will not be based on any a priori considerations of statistical power, but rather on the number of available cases from the different studies.

Fin del estudio sera 4 años despues de iniciado en Julio 2015 en Canada. Es un estudio en pacientes de varios estudios que han recibido Olaparib. El tamaño de la muestra no sera pre-definido pero se obtendra de los casos disponibles de distintos ensayos

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

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

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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)

None

Ninguno

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

2017-12-29

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-12-22

P. End of Trial
P.	End of Trial Status	Ongoing

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