Clinical Trials Register

Summary
EudraCT Number:	2011-001015-32
Sponsor's Protocol Code Number:	AGO-OVAR17/BOOST
National Competent Authority:	Sweden - MPA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-11-09
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

Sweden - MPA

A.2

EudraCT number

2011-001015-32

A.3

Full title of the trial

A multi-centre, open-label, randomised, twoarm Phase III trial to evaluate optimal treatment duration of first-line bevacizumab in combination with carboplatin and paclitaxel in patients with primary epithelial ovarian, fallopian tube or peritoneal cancer.

A.3.1

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

A.3.2

Name or abbreviated title of the trial where available

BOOST/OVAR-17

A.4.1

Sponsor's protocol code number

AGO-OVAR17/BOOST

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	AGO Research GmbH, AGO Study Group
B.1.3.4	Country	Germany
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	AGO Research GmbH, AGO Study Group
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Städt. Klinikum Solingen gGmbH, Frauenklinik
B.5.2	Functional name of contact point	Prof. Dr. med. J. Pfisterer
B.5.3	Address:
B.5.3.1	Street Address	Gotenstr. 1
B.5.3.2	Town/ city	Solingen
B.5.3.3	Post code	D-42653
B.5.3.4	Country	Germany
B.5.4	Telephone number	+49212 547-2371
B.5.6	E-mail	gynaekologie@klinikumsolingen.de

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	Avastin
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	Avastin
D.3.4	Pharmaceutical form	Concentrate and solvent 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	BEVACIZUMAB
D.3.9.1	CAS number	216974-75-3
D.3.9.2	Current sponsor code	RO4876646
D.3.9.3	Other descriptive name	rhuMAb VEGF, anti-VEGF
D.3.9.4	EV Substance Code	SUB16402MIG
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	25
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
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	Yes
D.3.11.13.1	Other medicinal product type	Recombinant Humanized Monoclonal Antibody

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

Following primary cytoreductive surgery, patients with newly diagnosed FIGO stage IIb -
IV (all grades and all histological types) epithelial ovarian cancer (EOC), fallopian tube
carcinoma (FTC) or primary peritoneal carcinomas (PPC) with indication for a platin/paclitaxel chemotherapy.

E.1.1.1

Medical condition in easily understood language

Ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinomas

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	21.0
E.1.2	Level	LLT
E.1.2	Classification code	10016412
E.1.2	Term	Female reproductive neoplasm NOS
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

To compare progression-free survival (PFS) (by RECIST v1.1, clinical or symptomatic) of
patients randomized to front-line paclitaxel/carboplatin with bevacizumab for 15 months
or 30 months.

E.2.2

Secondary objectives of the trial

To compare
• Objective response rate (ORR) by RECIST v1.1)
• Overall survival (OS)
• Quality of life (QoL)
o QOL and symptom control will be assessed using EORTC QLQ-C30 and QLQ-OV28 questionnaires
• Safety and tolerability
Further exploratory outcome measures on ancillary studies will include:
- Translational Sub Studies
- Complementary and Alternative Treatment Questionnaires

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Signed written informed consent obtained prior to initiation of any studyspecific
procedures and treatment as confirmation of the patients awareness and willingness to comply with the study requirements.
2. Primary diagnosis is confirmed by specialized pathology review (Germany only)
3. Females aged ≥ 18 years
4. Histologically confirmed, newly diagnosed
• Epithelial ovarian carcinoma
• Fallopian tube carcinoma
• Primary peritoneal carcinoma
AND FIGO stage IIb - IV (all grades and all histological types)
5. Patients should have already undergone surgical debulking, by a surgeon experienced
in the management of ovarian cancer, with the aim of maximal surgical cytoreduction according to the GCIG Conference Consensus Statement. There must be no planned surgical debulking prior to disease progression. Patients with stage III and IV disease in
whom initial surgical debulking was not appropriate or possible will still be eligible providing
• the patient has a histological diagnosis and
• debulking surgery prior to disease progression is not foreseen
6. Patients must be able to commence cytotoxic chemotherapy within 8 weeks of cytoreductive surgery. The first dose of bevacizumab can be omitted in both arms if the investigator decides to start chemotherapy within 4 weeks of surgery
7. ECOG performance status (PS) 0-2
8. Life expectancy > 3 months
9. Adequate bone marrow functiona (within 14 days prior to randomization)
• Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L
• Platelets (PLT) ≥ 100 x 109/L
• Hemoglobin (Hb) ≥ 9 g/dL (can be post-transfusion)
10. Adequate coagulation parametersa (within 14 days prior to randomization)
• Patients not receiving anticoagulant medication who have an International Normalised Ratio (INR) ≤ 1.5 and an Activated ProThrombin Time (aPTT) ≤ 1.5 x ULN
• The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR or aPTT is within therapeutic limits (according to institution medical standard) and the patient has been on a stable dose of anticoagulants for at least two weeks at the time of randomization
11. Adequate liver functiona (within 14 days prior to randomization)
• Serum bilirubin ≤ 1.5 x ULN
• Serum transaminases ≤ 2.5 x ULN
12. Urine dipstick for proteinuria < 2+. If urine dipstick is ≥ 2+, 24 hour urine must
demonstrate ≤ 1 g of protein in 24 hours
13. Adequate postoperative glomerulare filtration rate > 40 ml/min (estimates based on the Cockroft-Gault or Jelliffe formula are sufficient)

E.4

Principal exclusion criteria

1. Non-epithelial origin of the ovary, the fallopian tube or the peritoneum
2. Borderline tumours (tumours of low malignant potential) and FIGO stage Ia – IIa
tumours
3. Planned intraperitoneal cytotoxic chemotherapy
4. Prior systemic anti-cancer therapy for ovarian cancer (for example chemotherapy,
monoclonal antibody therapy, tyrosine kinase inhibitor therapy or hormonal therapy)
5. Surgery (including open biopsy) within 4 weeks prior to anticipated first dose of bevacizumab (allowing for the fact that bevacizumab can be omitted from the first cycle of chemotherapy).
It is strongly recommended that an interval of 7 days is left between the insertion of any central venous access devices (CVADs) and the onset of bevacizumab treatment.
6. Any planned surgery during the study treatment period plus 4 additional weeks to allow for bevacizumab clearance
7. Uncontrolled hypertensionb (sustained elevation of BP systolic > 150mmHg and/or diastolic > 100mmHg despite antihypertensive therapy)
8. Any previous radiotherapy to the abdomen or pelvis
9. Significant traumatic injury during 4 weeks preceding the potential first dose of bevacizumab
10. History or clinical suspicion of brain metastases or spinal cord compression. CT/MRI of the brain is mandatory (within 4 weeks prior to randomization) in case of suspected brain metastases. Spinal MRI is mandatory (within 4 weeks prior to randomization) in case of suspected spinal cord compression
11. History or evidence upon neurological examination of central nervous system (CNS) disease, unless adequately treated with standard medical therapy e.g. uncontrolled seizures
12. Previous Cerebro-Vascular Accident (CVA), Transient Ischaemic Attack (TIA) or Sub-Arachnoid Haemorrhage (SAH) within 6 months prior to randomization
13. Fertile woman of childbearing potential not willing to use adequate contraception
(oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) for the study duration and at least 6 months afterwards
14. Pregnant or lactating women
15. Treatment with other investigational agents, or participation in another clinical
trial testing a drug within the past 4 weeks before start of therapy concomitantly with this trial
16. Malignancies other than ovarian cancer within 5 years prior to randomization, except
for adequately treated
- carcinoma in situ of the cervix
- and/or basal cell skin cancer
- and/or non-melanomatous skin cancer
- carcinoma in situ of the breast
- and/or early endometrial carcinoma
as specified below. Patients may have received previous adjuvant chemotherapy for other malignancies e.g. breast or colorectal carcinoma if diagnosed over 5 years ago with no evidence of subsequent recurrence
17. Patients with synchronous primary endometrial carcinoma, or a past history of primary endometrial carcinoma, are excluded unless ALL of the following criteria for describing the endometrial carcinoma are met
• Disease stage FIGO stage ≤ IA (tumour invades less than one half of the myometrium)
18. Known hypersensitivity to bevacizumab and its excipients, Chinese hamster ovary
cell products or other recombinant human or humanised antibodies
19. Non healing wound, active ulcer or bone fracture. Patients with granulating incisions
healing by secondary intention with no evidence of facial dehiscence or infection are eligible but require 3 weekly wound examinations
20. History or evidence of thrombotic or hemorrhagic disorders within 6 months prior to randomization
21. Clinically significant cardiovascular disease, including
• Myocardial infarction or unstable angina within 6 months of randomization
• New York Heart Association (NYHA) ≥ Grade 2 Congestive Heart Failure (CHF)
• Poorly controlled cardiac arrhythmia despite medication (patients with rate-controlled atrial fibrillation are eligible)
• Grade ≥ 3 peripheral vascular disease (i.e. symptomatic and interfering with activities of daily living [ADL] requiring repair or revision)
22. Current or recent (within 10 days prior to randomization) chronic use of aspirin > 325 mg/dayc
23. Pre-existing sensory or motor neuropathy ≥ Grade 2
24. Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contra-indicates the use of an investigational drug or puts the patient at high risk for treatment-related complications

E.5 End points

E.5.1

Primary end point(s)

PFS: 4.5 years appr. (at least 523 PFS events have occured)

E.5.1.1

Timepoint(s) of evaluation of this end point

Each patient will be followed for the primary PFS and for the secondary endpoint OS every 6 months for at least 5 years after study treatment start.

See protocol Table 1A: FLOWCHART: Schedule of Assessments

E.5.2

Secondary end point(s)

OS: 7.5 years appr.

E.5.2.1

Timepoint(s) of evaluation of this end point

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

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

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

Quality of Life

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)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Different treatment duration with bevacizumab (15 months vs 30 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

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

Last patient last visit

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

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:

900

F.1.3

Elderly (>=65 years)

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

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

900

F.4.2.2

In the whole clinical trial

900

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 end their participation in the trial will be treated according to the sites standard of care. Follow up visits will be done regardles of disease status every 6 months for at least 5 years after study treatment start.

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

2013-01-10

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-03-05

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2020-11-26

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