Solid Tumor
Conditions
Brief summary
This extension study will provide continued onartuzumab and/or parent trial (P-trial) designated control treatments to participants with cancer who were previously enrolled in a company-sponsored onartuzumab P-trial and who derived benefit, as assessed by the responsible investigator, from the therapy administered in the P-trial. The study will also collect safety data with regard to administration of continued onartuzumab therapy.
Interventions
DRUGOnartuzumab
Onartuzumab 10 mg/kg or 15 mg/kg will be administered intravenously on Day 1 of each 14- or 21-day cycle as specified in the P-trial and as per clinical judgment and discretion of the investigator. The actual dose of onartuzumab will be determined on the bases of participants weight at the time of enrollment in extension trial (E-trial).
DRUGBevacizumab
All participants will continue on the same dose and schedule of control treatment (bevacizumab) as specified in their respective P-trial.
DRUGErlotinib
All participants will continue on the same dose and schedule of control treatment (erlotinib) as specified in their respective P-trial.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Enrolled and receiving either control treatment or onartuzumab-based study treatment in an eligible P-trial * Has not met the treatment discontinuation criteria specified in their P-trial protocol at the time of enrollment into the extension trial (E-trial) * Ability to begin treatment in the extension (rollover) protocol within 15 days following the last day of the study in the antecedent protocol * For women who are not postmenopausal (greater than or equal to \[\>/=\] 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use single or combined non-hormonal contraceptive methods that result in a failure rate of less than (\<) 1 percent (%) per year during the treatment period and for at least 180 days after the last dose of study drug * For men: agreement to remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \< 1% per year during the treatment period and for at least 180 days after the last dose of study drug and agreement to refrain from donating sperm during this same period
Exclusion criteria
* Pregnancy or lactation or intention to become pregnant during the study (serum pregnancy test required before enrollment) * Any non-protocol anti-cancer therapy started between discontinuation from treatment in P-trial and start of enrollment in E-trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Serious Adverse Events Considered Related to Onartuzumab | Baseline through the end of trial (approximately 3 years) | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. |
Countries
France, Italy, Japan, Latvia, Russia, Serbia, South Africa, Spain
Participant flow
Recruitment details
Participants with solid tumors previously enrolled in an F. Hoffmann-La Roche and/or Genentech parent trial (P-trial) who received either the control treatment or onartuzumab-based study treatment, had not met the treatment discontinuation criteria for their P-trial, and were able to start treatment within 42 days of the last day of their P-trial.
Participants by arm
| Arm | Count |
|---|---|
| Control and/or Onartuzumab Treatment Participants received treatment with either the control treatment (erlotinib, bevacizumab) and/or ornartuzumab-based study treatment until disease progression, unacceptable treatment-related toxicity, withdrawal of consent, or death (whichever occurred first). | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Death | 2 |
| Overall Study | Disease Progression | 3 |
| Overall Study | Physician Decision | 2 |
| Overall Study | Study Termination by Sponsor | 4 |
Baseline characteristics
| Characteristic | Control and/or Onartuzumab Treatment |
|---|---|
| Age, Continuous | 59.67 Years STANDARD_DEVIATION 9.78 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 12 |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 5 / 12 |
Outcome results
Primary
Percentage of Participants With Serious Adverse Events Considered Related to Onartuzumab
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Time frame: Baseline through the end of trial (approximately 3 years)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control and/or Onartuzumab Treatment | Percentage of Participants With Serious Adverse Events Considered Related to Onartuzumab | 0 Percent |