Clinical Trials Register

Summary
EudraCT Number:	2011-005533-39
Sponsor's Protocol Code Number:	Debio0932-201
National Competent Authority:	Hungary - National Institute of Pharmacy
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2014-03-04
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

Hungary - National Institute of Pharmacy

A.2

EudraCT number

2011-005533-39

A.3

Full title of the trial

A Phase I-II evaluation of the safety and efficacy of the oral HSP90 inhibitor Debio 0932 in combination with standard of care in first- and second-line therapy of patients with Stage IIIb or IV Non-small Cell Lung Cancer - the HALO study (HSP90 inhibition And Lung cancer Outcomes)

A.3.1

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

A clinical trial to study the safety and effectiveness of Debio 0932 in combination with standard of care in non-small cell lung cancer

A.3.2

Name or abbreviated title of the trial where available

HALO

A.4.1

Sponsor's protocol code number

Debio0932-201

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	Debiopharm International SA
B.1.3.4	Country	Switzerland
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	Debiopharm International SA
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	INC Research LLC
B.5.2	Functional name of contact point	Regulatory Affairs Project Manager
B.5.3	Address:
B.5.3.1	Street Address	Riverview, Meadows Business Park, Station Approach, Blackwater
B.5.3.2	Town/ city	Camberley, Surrey
B.5.3.3	Post code	GU17 9AB
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	+441276481123
B.5.5	Fax number	+441276609041
B.5.6	E-mail	tamara.parr@incresearch.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	Debio 0932, 100mg tablet
D.3.2	Product code	Debio 0932
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.3.9.2	Current sponsor code	Debio 0932
D.3.9.3	Other descriptive name	Debio 0932
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	100
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: 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	Debio 0932, 250 mg tablet
D.3.2	Product code	Debio 0932
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.3.9.2	Current sponsor code	Debio 0932
D.3.9.3	Other descriptive name	Debio 0932
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	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	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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Non-small Cell Lung Cancer

E.1.1.1

Medical condition in easily understood language

Non-small Cell Lung Cancer

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	16.1
E.1.2	Level	LLT
E.1.2	Classification code	10025054
E.1.2	Term	Lung cancer non-small cell stage IIIB
E.1.2	System Organ Class	100000004864

E.1.2 Medical condition or disease under investigation

E.1.2	Version	16.1
E.1.2	Level	LLT
E.1.2	Classification code	10025055
E.1.2	Term	Lung cancer non-small cell stage IV
E.1.2	System Organ Class	100000004864

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Part A :To determine the MTD of Debio 0932 in combination with cisplatin/pemetrexed and cisplatin/gemcitabine in treatment-naïve patients with Stage IIIb or IV NSCLC and with docetaxel in previously treated patients with Stage IIIb or IV NSCLC.
Part B : To compare the effect of adding Debio 0932 to combination chemotherapy with cisplatin/pemetrexed and cisplatin/gemcitabine on the rate of PFS at 6 months in first-line therapy of patients with Stage IIIb or IV NSCLC.
Part C : To compare the effect of adding Debio 0932 to docetaxel on the change in tumour size in second-line therapy of patients with Stage IIIb or IV NSCLC.

E.2.2

Secondary objectives of the trial

Part A: Investigate for Debio 0932, in combination with cisplatin/pemetrexed, cisplatin/gemcitabine, and docetaxel:1. RD
2. Safety;3. PK & potential for drug-drug interactions;4. Anti-tumour activity;5. PD biomarkers of activity
Part B:Compare between treatment arms:1. Best overall response rate;2. Duration of objective response;3. Change in tumour size from baseline until 6 months;4. Overall survival;5. Incidence of new symptomatic brain metastases. Investigate for Debio 0932, in combination with cisplatin/pemetrexed and cisplatin/gemcitabine: 6. Safety; 7. PK and PD profile
Part C: To compare between treatment arms:1. Best overall response rate; 2. Duration of objective response;3. PFS at 6 Months;4. Overall survival;5. Incidence of new symptomatic brain metastases. To investigate for Debio 0932, in combination with docetaxel: 6. Safety;7. PK and PD profile. Parts A, B & C:
Pharmacogenomic, tumour pharmacogenetic, proteomic, & pharmacogenetic factors predictive of response.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Part A :
1. Age ≥ 18 years;
2. Diagnosis of NSCLC with confirmed squamous or non-squamous tumour histology, without known EGFR mutation;
3. Archived tumour sample available;
4. Advanced or metastatic disease (Stage IIIb or IV) ;
5. Patients to be treated with cisplatin/gemcitabine or cisplatin/pemetrexed: No previous systemic treatment with chemotherapy, targeted therapy or investigational agents (except adjuvant therapy if > 6 months ago); Patients to be treated with docetaxel: ≥ 1 previous treatment with chemotherapy.
6. Candidate for treatment with cisplatin/pemetrexed or cisplatin/gemcitabine or docetaxel as determined by the Investigator;
7. Measurable disease by the RECIST criteria;
8. ECOG performance score 0 - 1;
9. Life expectancy ≥ 3 months;
10. ANC ≥ 1 500/μL;
11. Platelets ≥ 100 000/μL;
12. Creatinine clearance ≥ 60 mL/minutes (Cockroft – Gault formula);
13. AST and ALT ≤ 2.5 x ULN; in case of documented liver metastases, AST and ALT ≤ 3.5 x ULN;
14. LVEF ≥ 55% on cardiac ultrasound;
15.If female, neither pregnant nor lactating;
16. Women of child-bearing potential:
a. Negative pregnancy test at screening;
b. Agreement to use appropriate contraception methods from study entry to 6 months after the last day of treatment.
17. Male patients agree to use contraception methods from study entry to 6 months after the last day of treatment;
18. Provide written informed consent;
19. Ability to comply with study procedures.

Part B :
1. Age ≥ 18 years;
2. Diagnosis of NSCLC with confirmed squamous or non-squamous tumour histology, without known EGFR mutation, and with known KRAS status;
3. Archived tumour sample available;
4. Advanced or metastatic disease (Stage IIIb or IV) ;
5. No previous systemic treatment with chemotherapy, targeted therapy or investigational agents (except adjuvant therapy if > 6 months ago) ;
6. Candidate for treatment with cisplatin/pemetrexed or cisplatin/gemcitabine as determined by the Investigator;
7. Measurable disease by the RECIST criteria;
8. ECOG performance score 0 - 1;
9. Life expectancy ≥ 3 months;
10. Absolute neutrophil count ≥ 1 500/μL;
11. Platelets ≥ 100 000/μL;
12. Creatinine clearance ≥ 60 mL/minutes (Cockroft – Gault formula);
13. AST and ALT ≤ 2.5 x ULN; in case of documented liver metastases, AST and ALT ≤ 3.5 x ULN;
14. LVEF ≥ 55% on cardiac ultrasound;
15. If female, neither pregnant nor lactating;
16. Women of child-bearing potential:
a. Negative pregnancy test at screening;
b. Agreement to use appropriate contraception methods from study entry to 6 months after the last day of treatment.
17. Male patients agree to use contraception methods from study entry to 6 months after the last day of treatment;
18. Provide written informed consent;
19. Ability to comply with study procedures.

Part C :
1. Age ≥ 18 years;
2. Diagnosis of NSCLC with confirmed squamous or non-squamous tumour histology, without known EGFR mutation, and with known KRAS status;
3. Archived tumour sample available unless previous participant in Part B;
4. Advanced or metastatic disease (Stage IIIb or IV) ;
5. One of these two criteria should be fulfilled:
a. Previous participant of Part B with PD under study treatment OR
b. New patient in case of futility of the interim analysis of Part B or in case of an insufficient number of patients enrolling from Part B with PD after dual chemotherapy with cisplatin/pemetrexed or cisplatin/gemcitabine or for any other reason.
6. Candidate for treatment with docetaxel as determined by the Investigator;
7. Measurable disease by the RECIST criteria;
8. ECOG performance score 0 - 1;
9. Life expectancy ≥ 3 months;
10. Absolute neutrophil count ≥ 1 500/μL;
11. Platelets ≥ 100 000/μL;
12. Creatinine clearance ≥ 60 mL/minutes (Cockroft – Gault formula);
13. AST and ALT ≤ 2.5 x ULN; in case of documented liver metastases, AST and ALT ≤ 3.5 x ULN;
14. LVEF ≥ 55% on cardiac ultrasound;
15. If female, neither pregnant nor lactating;
16. Women of child-bearing potential:
a. Negative pregnancy test at screening;
b. Agreement to use appropriate contraception methods from study entry to 6 months after the last day of treatment.
17. Male patients agree to use contraception methods from study entry to 6 months after the last day of treatment;
18. Provide written informed consent;
19. Ability to comply with study procedures.

E.4

Principal exclusion criteria

Part A :
1. Unresolved toxicity from previous treatment;
2. Symptomatic brain metastases;
3. For patients on docetaxel: Serum bilirubin levels > ULN associated with serum ALP levels > 6 times ULN;
4. Gastro-intestinal disorders that could affect drug absorption (including, but not limited to, major abdominal surgery, significant bowel obstruction, ulcerative colitis, Crohn’s disease);
5. Concurrent treatment with any other systemic anti-cancer therapy;
6. Concomitant treatment with any drug on the prohibited medication list (provided separately);
7. Serious concomitant uncontrolled medical conditions.

Part B :
1. Unresolved toxicity from previous treatment;
2. Symptomatic brain metastases;
3. Gastro-intestinal disorders that could affect drug absorption (including, but not limited to, major abdominal surgery, significant bowel obstruction, ulcerative colitis, Crohn’s disease);
4. Concurrent treatment with any other systemic anti-cancer therapy;
5. Concomitant treatment with any drug on the prohibited medication list (provided separately);
6. Serious concomitant uncontrolled medical conditions.

Part C :
1. Unresolved toxicity from previous treatment;
2. Symptomatic brain metastases;
3. Serum bilirubin levels > ULN associated with serum ALP levels > 6 times ULN;
4. Gastro-intestinal disorders that could affect drug absorption (including, but not limited to, major abdominal surgery, significant bowel obstruction, ulcerative colitis, Crohn’s disease) ;
5. Concurrent treatment with any other systemic anti-cancer therapy;
6. Concomitant treatment with any drug on the prohibited medication list (provided separately);
7. Serious concomitant uncontrolled medical conditions.

E.5 End points

E.5.1

Primary end point(s)

Part A : Occurrence of DLTs.

Part B : Percentage of patients with PFS at 6 months.

Part C : Change in tumour size from baseline until 6 months.

E.5.1.1

Timepoint(s) of evaluation of this end point

At end of each (Parts A, B and C) study treatment phase.

E.5.2

Secondary end point(s)

Part A :
1. Change in vital signs, ECG, and ECOG PS.
2. Incidence of AEs and SAEs according to NCI-CTCAE criteria.
3. Incidence of laboratory abnormalities according to NCI-CTCAE criteria.
4. Incidence of treatment discontinuations due to AEs and SAEs.
5. Change in LVEF
6.Pharmacokinetic parameters of Debio 0932 and its metabolite Debio 0932-MET1 in plasma at steady state alone (on Day 21) and in combination with cisplatin/pemetrexed, cisplatin/gemcitabine, and docetaxel (on Day 22): C0h, Cmax, tmax, AUC0-tlast, AUC0-τ, Css av, FI, λz, t1/2, CL/F, and Vz/F calculated for all patients using non-compartmental analysis.
7. Pharmacokinetic parameters of cisplatin (total and unbound)/pemetrexed, cisplatin (total and unbound)/gemcitabine, and docetaxel in plasma after single infusion alone (on Day 1) and in combination with Debio 0932 at steady-state (on Day 22): Cmax, AUC0-tlast, AUC0-∞, λz, t1/2, MRT, CL, Vss, and Vz calculated for all patients using non-compartmental analysis.
8. Best overall response, i.e., best response recorded from start of study treatment until study end.
9. Optional exploration of pharmacodynamic biomarkers in plasma and PBMCs.
10. Pharmacogenomic, tumour pharmacogenetic, proteomic, and pharmacogenetic factors predictive of response to Debio 0932.

Part B :
1. Best overall response, i.e. best response recorded from start of study treatment until study end.
2. Duration of objective response.
3. Change in tumour size from baseline until 6 months.
4. Overall survival.
5. In patients without brain metastases at baseline: incidence of new symptomatic brain metastases.
6. Safety and tolerability (vital signs, ECG, ECOG PS, LVEF, and AEs, SAEs, and laboratory abnormalities according to NCI-CTCAE criteria).
7. Optional exploration of pharmacodynamic biomarkers in plasma and PBMCs.
8. Pharmacogenomic, tumour pharmacogenetic, proteomic, and pharmacogenetic factors predictive of response to Debio 0932.
9. If applicable, plasma PK parameters of Debio 0932 and its main metabolite Debio 0932-MET1 derived from a compartmental population PK data analysis (including covariates such as demographic characteristics and pharmacogenetics).

Part C :
1. Best overall response, i.e. best response recorded from start of study treatment until study end.
2. Duration of objective response.
3. Percentage of patients with PFS at 6 Months.
4. Overall survival.
5. In patients without brain metastases at baseline: incidence of new symptomatic brain metastases.
6. Safety and tolerability (vital signs, ECG, ECOG PS, LVEF, and AEs, SAEs and laboratory abnormalities according to NCI-CTCAE criteria).
7. Optional exploration of pharmacodynamic biomarkers in plasma and PBMCs.
8. Pharmacogenomic, tumour pharmacogenetic, proteomic, and pharmacogenetic factors predictive of response to Debio 0932.
9. If applicable, plasma PK parameters of Debio 0932 and its main metabolite Debio 0932-MET1 derived from a compartmental population PK data analysis (including covariates such as demographic characteristics and pharmacogenetics)

E.5.2.1

Timepoint(s) of evaluation of this end point

At end of each (Parts A, B and C) study treatment phase.

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

Yes

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

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

Yes

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

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

Yes

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Open-label, non randomised, dose escalation

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

Dose-escalation study to determine the maximum tolerated dose of Debio 0932

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

E.8.6.2

Trial being conducted completely outside of the EEA

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

Study will be considered as completed when all patients have withdrawn from the study (last visit of last subject in Part C of the study).

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:

149

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

149

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

298

F.4.2.2

In the whole clinical trial

298

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)

Patients who have ended the participation in the trial are to be treated and followed up according to accepted medical practice.

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

2014-05-08

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-04-28

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2014-11-10

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