Neoplasms
Conditions
Brief summary
This single-arm, open-label, multicenter extension study will provide continued bevacizumab therapy to participants with solid tumors who were previously enrolled in a Roche/Genentech sponsored study and who derived benefit from the bevacizumab therapy. Participants will receive the same dose and regimen of bevacizumab as used in the previous parent trial and continue this treatment until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
Interventions
DRUGBevacizumab
Bevacizumab will be administered at 7.5 or 15 milligrams per kilogram (mg/kg) intravenously every 3 weeks (Q3W), or 5 or 10 mg/kg intravenously every 2 weeks (Q2W).
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All participants were assigned the same treatment. The Number of Arms represent the reporting groups of all subjects according to disease.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant is treated with bevacizumab at the end of the Roche/Genentech sponsored parent trial and continues to have benefit as judged by the investigator * Eligible for continuation of bevacizumab treatment at the end of a parent trial, according to parent trial protocol * Able to comply with this extension study protocol (MO25757)
Exclusion criteria
* Evidence of disease progression assessed according to parent trial protocol during the screening phase for this extension study * Evidence of any adverse event potentially attributable to bevacizumab, for which the local label recommends permanent discontinuation * A treatment interruption with bevacizumab of more than 42 days since the last administration of bevacizumab in the parent trial * Evidence of any other disease that would put the participant at high risk for treatment-related complications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Adverse Events | Baseline up to approximately 81 months | An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | Baseline up to approximately 81 months | Progression free survival is defined as the time from first dose of Bevacizumab in this extension trial (E-trial) to the time of first documented disease progression or death due to any cause, whichever occurs first. |
| Overall Survival (OS) | Baseline up to approximately 81 months | Overall survival time is defined as the time from first dose of Bevacizumab in the E-trial to death from any cause. |
Countries
Austria, Brazil, Bulgaria, Canada, Czechia, Estonia, France, Germany, Hungary, Italy, Mexico, Netherlands, Romania, Russia, Slovakia, South Africa, South Korea, Spain, Sweden, Turkey (Türkiye), United Kingdom
Participant flow
Pre-assignment details
The number of participants enrolled over the planned recruitment period was open. 95 participants actually enrolled in this study.
Participants by arm
| Arm | Count |
|---|---|
| Breast Cancer Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first. | 11 |
| Ovarian Cancer or Peritoneal Carcinoma Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first. | 41 |
| Colorectal Cancer Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first. | 7 |
| Renal Cell Carcinoma Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first. | 6 |
| Non-Squamous, Non-Small Cell Lung Cancer Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first. | 16 |
| Glioblastoma Multiforme Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first. | 14 |
| Total | 95 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Bevacizumab treatment provision changed | 0 | 6 | 2 | 0 | 1 | 3 |
| Overall Study | Death | 1 | 0 | 0 | 1 | 1 | 1 |
| Overall Study | multiple reasons | 0 | 3 | 0 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 4 | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Breast Cancer | Total | Glioblastoma Multiforme | Non-Squamous, Non-Small Cell Lung Cancer | Renal Cell Carcinoma | Colorectal Cancer | Ovarian Cancer or Peritoneal Carcinoma |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 54.5 years STANDARD_DEVIATION 7.3 | 56.9 years STANDARD_DEVIATION 11.4 | 49.5 years STANDARD_DEVIATION 10.9 | 58.5 years STANDARD_DEVIATION 10.5 | 63.5 years STANDARD_DEVIATION 9.8 | 66.7 years STANDARD_DEVIATION 13.9 | 56.7 years STANDARD_DEVIATION 11.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants | 95 Participants | 14 Participants | 16 Participants | 6 Participants | 7 Participants | 41 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 11 Participants | 67 Participants | 4 Participants | 6 Participants | 2 Participants | 3 Participants | 41 Participants |
| Sex: Female, Male Male | 0 Participants | 28 Participants | 10 Participants | 10 Participants | 4 Participants | 4 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 11 | 0 / 41 | 0 / 7 | 1 / 6 | 1 / 16 | 1 / 14 |
| other Total, other adverse events | 10 / 11 | 31 / 41 | 5 / 7 | 6 / 6 | 12 / 16 | 14 / 14 |
| serious Total, serious adverse events | 2 / 11 | 2 / 41 | 2 / 7 | 3 / 6 | 5 / 16 | 3 / 14 |
Outcome results
Primary
Percentage of Participants With Adverse Events
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
Time frame: Baseline up to approximately 81 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Breast Cancer | Percentage of Participants With Adverse Events | 90.9 percentage of participants |
| Ovarian Cancer or Peritoneal Carcinoma | Percentage of Participants With Adverse Events | 78.0 percentage of participants |
| Colorectal Cancer | Percentage of Participants With Adverse Events | 71.4 percentage of participants |
| Renal Cell Carcinoma | Percentage of Participants With Adverse Events | 100.0 percentage of participants |
| Non-Squamous, Non-Small Cell Lung Cancer | Percentage of Participants With Adverse Events | 75.0 percentage of participants |
| Glioblastoma Multiforme | Percentage of Participants With Adverse Events | 83.2 percentage of participants |
Secondary
Overall Survival (OS)
Overall survival time is defined as the time from first dose of Bevacizumab in the E-trial to death from any cause.
Time frame: Baseline up to approximately 81 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Breast Cancer | Overall Survival (OS) | 38.82 months | Standard Deviation 24.159 |
| Ovarian Cancer or Peritoneal Carcinoma | Overall Survival (OS) | 27.35 months | Standard Deviation 20.02 |
| Colorectal Cancer | Overall Survival (OS) | 20.30 months | Standard Deviation 23.761 |
| Renal Cell Carcinoma | Overall Survival (OS) | 11.98 months | Standard Deviation 10.95 |
| Non-Squamous, Non-Small Cell Lung Cancer | Overall Survival (OS) | 18.31 months | Standard Deviation 14.962 |
| Glioblastoma Multiforme | Overall Survival (OS) | 12.99 months | Standard Deviation 10.795 |
Secondary
Progression Free Survival (PFS)
Progression free survival is defined as the time from first dose of Bevacizumab in this extension trial (E-trial) to the time of first documented disease progression or death due to any cause, whichever occurs first.
Time frame: Baseline up to approximately 81 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Breast Cancer | Progression Free Survival (PFS) | 35.31 months | Standard Deviation 23.809 |
| Ovarian Cancer or Peritoneal Carcinoma | Progression Free Survival (PFS) | 24.39 months | Standard Deviation 19.759 |
| Colorectal Cancer | Progression Free Survival (PFS) | 17.98 months | Standard Deviation 24.202 |
| Renal Cell Carcinoma | Progression Free Survival (PFS) | 9.31 months | Standard Deviation 12.046 |
| Non-Squamous, Non-Small Cell Lung Cancer | Progression Free Survival (PFS) | 17.14 months | Standard Deviation 14.152 |
| Glioblastoma Multiforme | Progression Free Survival (PFS) | 11.31 months | Standard Deviation 10.301 |