To provide continued bevacizumab therapy as single agent or in combination with an anti-cancer drug to patients with cancer, who were previously enrolled in a F. Hoffmann-La Roche (Roche)/ Genentech sponsored bevacizumab study (i.e. the Parent, P-…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To provide continued bevacizumab therapy as single agent or in combination with
an anti-cancer drug to patients with cancer who were previously enrolled in a
Roche/Genentech - sponsored bevacizumab P-trial and who derived benefit from
the therapy administered in the P-trial To collect safety data with regard to
long-term administration of bevacizumab.
Secondary outcome
To link data with the appropriate P-trial database to analyse scientific
questions of interest. Details will be described in the statistical analysis
plan (SAP).
Background summary
Bevacizumab is usually given until progression of the underlying cancer unless
patients withdraw consent or experiences toxicities that lead to
discontinuation. The time to progression is very variable from patient to
patient.
Trials need to have a defined end. This is often event driven for comparative
trials looking into PFS or OS. Single-arm trials often end after a prespecified
time after last patient first visit. At their completion or closure some
patients might still be on treatment with bevacizumab and benefit from the
continuation of the therapy with bevacizumab as their cancer has not
progressed. Roche/Genentech had committed to provide treatment for above
mentioned patients in the P-trial. This was also to ensure that all patients
have the chance to receive similar treatment enrolled in the same trial (i.e.
the first patient enrolled in a trial can benefit during enrolment and
follow-up phase of a trial, where as the last
patient enrolled in a trial can benefit during follow-up phase and in this
E-trial).
All eligible patients from qualifying bevacizumab P-trials can be enrolled in
this E-trial, ensuring those patients have access to bevacizumab and their
safety is monitored adequately.
Study objective
To provide continued bevacizumab therapy as single agent or in combination with
an anti-cancer drug to patients with cancer, who were previously enrolled in a
F. Hoffmann-La Roche (Roche)/ Genentech sponsored bevacizumab study (i.e. the
Parent, P-trial) and who
derived benefit from the therapy administered in the P-trial. To collect safety
data with regard to long-term administration of bevacizumab.
Study design
Multicenter, open-label, single-arm phase IV trial. Patients on bevacizumab at
P-trial end will be enrolled immediately thereafter. Patients will receive
treatment with bevacizumab as during their P-trial until progression of
disease, unacceptable toxicity, withdrawal of consent or death (whichever
occurs first).
Intervention
Not applicable
Study burden and risks
The MO25757 E-trial is designed to ensure an optimal risk/benefit ratio. (See
protocol section 1.3)
Beneluxlaan 2a
3446 GR Woerden
NL
Beneluxlaan 2a
3446 GR Woerden
NL
Listed location countries
Age
Inclusion criteria
1. Written informed consent prior to any study-specific procedure.;2. Patient is treated with bevacizumab at the end of the Roche/Genentech sponsored P-trial and continues to have benefit as judged by the investigator;3. Eligible for continuation of bevacizumab treatment at the end of the Parent-trial, according to Parent-trial protocol;4. Able to comply with the Extension-trial protocol MO25757;5. Female patients should not be pregnant or breastfeeding.;6. Female patients of childbearing potential/fertile male patients must use a highly effective contraceptive method during the Extension-trial and for a period of at least 6 months following the last administration of Extension-trial drug(s).
Exclusion criteria
1. Evidence of disease progression assessed according to Parent-trial protocol during the screening phase for this Extension-trial;2. Evidence of any adverse event potentially attributable to bevacizumab, for which the local label recommends permanent discontinuation.;3. A treatment interruption with bevacizumab of more than 42 days since the last administration of bevacizumab in the Parent-trial.;4. Evidence of any other disease, neurological or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of the investigational drug(s) or puts the patient at high risk for treatment-related complications.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2011-002009-31-NL |
| CCMO | NL40453.091.12 |