Solid tumours MedDRA version: 14.1 Level: LLT Classification code 10049280 Term: Solid tumour System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: LLT Classification code 10065143 Term: Malignant solid tumour System Organ Class: 10029104 - Neoplasms benign, malig
Conditions
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
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). 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| Main 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 ;Secondary Objective: n.a.;Primary end point(s): Safety data (AE grade =3 related to bevacizumab, SAEs, cause of deaths);Timepoint(s) of evaluation of this end point: There will be a safety interim analysis approximately 3 years after the enrolment of the first patient in this Extension-trial. A final analyses will be done at the trial end. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable | — |
Countries
Argentina, Australia, Austria, Bulgaria, Canada, China, Czech Republic, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Korea, Republic of, Latvia, Lithuania, Mexico, Netherlands, Russian Federation, Slovakia, Spain, United Kingdom
Contacts
Public ContactTrial Information Support Line-TISL
F.Hoffmann-La Roche Ltd
Outcome results
None listed