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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 31 January 2017
Main ID:  EUCTR2012-003138-17-EE
Date of registration: 08/05/2013
Prospective Registration: Yes
Primary sponsor: F. Hoffmann-La Roche Ltd
Public title: A comparison of continuous Avastin treatment or placebo in addition to lomustine followed by standard treatment for worsening brain cancer
Scientific title: A double-blind, placebo-controlled, randomized, Phase II study evaluating the efficacy and safety of addition of continuous multiple line bevacizumab treatment to lomustine in second (2nd)-line followed by standard of care (SOC) in third (3rd)-line and beyond compared to addition of placebo, following first progression of disease (PD1) in patients with glioblastoma (GBM) after first (1st)-line treatment with radiotherapy, temozolomide and bevacizumab
Date of first enrolment: 28/05/2013
Target sample size: 300
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-003138-17
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries of recruitment
Austria Bulgaria Croatia Estonia Finland France Greece Ireland
Italy Latvia Lithuania Portugal Romania Spain Sweden Turkey
United Kingdom
Contacts
Name: Trial Information Support Line-TISL   
Address:  Grenzacherstrasse 124 4070 Basel Switzerland
Telephone:
Email: global.rochegenentechtrials@roche.com
Affiliation:  F.Hoffmann-La Roche Ltd
Name: Trial Information Support Line-TISL   
Address:  Grenzacherstrasse 124 4070 Basel Switzerland
Telephone:
Email: global.rochegenentechtrials@roche.com
Affiliation:  F.Hoffmann-La Roche Ltd
Key inclusion & exclusion criteria
Inclusion criteria:
• Are currently enrolled in Study MO28347 and have provided additional consent following amendment 6 to the protocol, which changed the study from a Phase IIIb to a Phase II study
• Age = 18 years .
• Karnofsky performance status (KPS) = 60.
• Newly diagnosed, histologically confirmed glioblastoma not previously treated with chemotherapy or radiotherapy
• If female and not postmenopausal (< 12 months of amenorrhea) or surgically sterile, must agree to use a highly effective contraceptive method during the treatment period and for at least 6 months after the last dose of study drug
• Mandatory tissue collection during pre-study surgery or biopsy for confirmation of the diagnosis and pathology.
• Craniotomy or intracranial biopsy site must be adequately healed. Study treatment should be initiated > 28 days following the last surgical procedure.

Principal eligibility criteria at the time of randomisation (following PD1):
• Documented disease progression (PD1)
• Eligibility for 2nd-line treatment with lomustine and bevacizumab as investigational medicinal products.
• Patients for whom operation or re-operation is indicated before 2nd-line starts, tissue submission is mandatory
• Eastern Cooperative Oncology Group (ECOG) performance status is 0-2 when starting 2nd-line treatment
• Bevacizumab was well tolerated and treatment interruption lasted not more than 60 days


Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 234
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 66

Exclusion criteria:
• Any prior chemotherapy for GBM and low grade astrocytomas.
• Any prior radiotherapy to the brain or prior radiotherapy resulting in a potential overlap in the radiation field.
• Prior or current anti-angiogenic treatment
•Treatment with any other investigational drug within 28 days or 2 investigational agent half-lives (whichever is longer) prior to first study treatment
• Inadequate hematological, renal or liver function
• Inadequately controlled hypertension
• Prior history of gastrointestinal perforation or abscess
• Clinically significant cardiovascular disease, NYHA >/= Grade II congestive heart failure, or serious cardiac arrhythmia uncontrolled by medication or potentially interfering with protocol treatment
• History or evidence of central nervous system disease unrelated to cancer unless adequately treated with standard medical therapy
• History or evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding
• Serious non-healing wound, active ulcer, or untreated bone fracture
• Known hypersensitivity to any component of Avastin/placebo or any of the study drugs
• Active infection requiring intravenous antibiotics at start of study treatment
• Other malignancy within 5 years prior to study enrollment, except for carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer or ductal carcinoma in situ treated with curative intent
• Pregnant or lactating women
• Participation in any other study



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Therapeutic area: Diseases [C] - Cancer [C04]
Glioblastoma
MedDRA version: 19.0 Level: PT Classification code 10018336 Term: Glioblastoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intervention(s)

Trade Name: Avastin
Product Name: Bevacizumab
Product Code: RO4876646/F02
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: BEVACIZUMAB
CAS Number: 216974-75-3
Current Sponsor code: RO4876646
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use

Trade Name: Cecenu
Pharmaceutical Form: Capsule
INN or Proposed INN: Lomustine
CAS Number: 13010-47-4
Current Sponsor code: Ro 021-6173
Other descriptive name: LOMUSTINE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-

Primary Outcome(s)
Main Objective: • To assess the efficacy of addition ad continuous multiple line bevacizumab treatment to lomustine in 2nd-line followed by standard of care (SOC) in 3rd-line and beyond compared to addition of bevacizumab-placebo, as measured by overall survival (OS) from randomization at first progression of disease (PD1).
Timepoint(s) of evaluation of this end point: When 130 events have been observed
Primary end point(s): Overall survival (OS)
Secondary Objective: To assess:
• overall survival as measured from randomization at PD1.
• progression free survival from randomization at PD1, to 2nd PD (PD2) (PFS2), and to 3rd PD (PD3) (PFS3).
• response rates (RRs), disease control rates (DCRs), and durations of response at PD2 and PD3.
• the safety of bevacizumab treatment across multiple lines of treatment and from randomization at PD1.
• HRQoL, neurocognitive function (NCF) and resource utilization
Secondary Outcome(s)
Secondary end point(s): - 2nd and 3rd line progression free survival (PFS)
- Response, duration of response and disease control rates in 2nd and 3rd line
- Safety
- Neurocognitive function, Health Related QoL, resource utilization
Timepoint(s) of evaluation of this end point: at the time of the primary endpoint (when 130 events have been observed)
Secondary ID(s)
MO28347
2012-003138-17-AT
NCT01860638
Source(s) of Monetary Support
F. Hoffmann-La Roche Ltd
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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