An Extension Study of Onartuzumab in Participants With Solid Tumors on Study Treatment Previously Enrolled in a Company Sponsored Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Control and/or Onartuzumab treatment Participants will receive treatment with either the control treatment (erlotinib, bevacizumab) and/or onartuzumab-based study treatment (as during their P-trial) until progression of disease, unacceptable treatment related toxicity, withdrawal of consent, or death (whichever occurs first). All participants will continue on the same dose and schedule of control treatment as specified in their respective P-trial. The dose of onartuzumab will be calculated based on the participant's weight at the screening visit for the E-trial. |
Drug: Onartuzumab
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).
Drug: Bevacizumab
All participants will continue on the same dose and schedule of control treatment (bevacizumab) as specified in their respective P-trial.
Other Names:
Drug: Erlotinib
All participants will continue on the same dose and schedule of control treatment (erlotinib) as specified in their respective P-trial.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hopital Roger Salengro | Lille | France | 59037 | |
| 2 | Azienda Ospedaliero Universitaria San Giovanni Battista Di Torino | Torino | Piemonte | Italy | 10126 |
| 3 | National Hospital Organization Shikoku Cancer Center | Ehime | Japan | 791-0280 | |
| 4 | Rigas Austrumu Kliniska Universitates slimnica, Latvijas Onkologijas centrs | Riga | Latvia | LV 1079 | |
| 5 | Ivanovo Regional Oncology Dispensary | Ivanovo | Russian Federation | 153040 | |
| 6 | Clin Hospital Center - Kragujevac; Pulmonary Diseases | Kragujevac | Serbia | 34000 | |
| 7 | University of the Witwatersrand Research | Johannesburg | South Africa | 2193 | |
| 8 | Sandton Oncology Medical Group | Sandton | South Africa | 2196 | |
| 9 | Hospital Univ Vall d'Hebron; Servicio de Oncologia | Barcelona | Spain | 08035 | |
| 10 | HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia | Madrid | Spain | 28050 |
Sponsors and Collaborators
- Hoffmann-La Roche
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Study Documents (Full-Text)
More Information
Publications
None provided.- GO29646
- 2014-005438-69
Study Results
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. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Control and/or Onartuzumab Treatment |
|---|---|
| Arm/Group Description | 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). |
| Period Title: Overall Study | |
| STARTED | 12 |
| COMPLETED | 0 |
| NOT COMPLETED | 12 |
Baseline Characteristics
| Arm/Group Title | Control and/or Onartuzumab Treatment |
|---|---|
| Arm/Group Description | 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). |
| Overall Participants | 12 |
| Age (Years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [Years] |
59.67
(9.78)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
6
50%
|
| Male |
6
50%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
0
0%
|
| Not Hispanic or Latino |
12
100%
|
| Unknown or Not Reported |
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
1
8.3%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
0
0%
|
| White |
9
75%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
2
16.7%
|
Outcome Measures
| Title | Percentage of Participants With Serious Adverse Events Considered Related to Onartuzumab |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Control and/or Onartuzumab Treatment |
|---|---|
| Arm/Group Description | 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). |
| Measure Participants | 12 |
| Number [Percent] |
0
|
Adverse Events
| Time Frame | Baseline through the end of trial (approximately 3 years) | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Control and/or Onartuzumab Treatment | |
| Arm/Group Description | 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). | |
All Cause Mortality |
||
| Control and/or Onartuzumab Treatment | ||
| Affected / at Risk (%) | # Events | |
| Total | 2/12 (16.7%) | |
Serious Adverse Events |
||
| Control and/or Onartuzumab Treatment | ||
| Affected / at Risk (%) | # Events | |
| Total | 5/12 (41.7%) | |
| Cardiac disorders | ||
| Sudden cardiac death | 1/12 (8.3%) | |
| Renal and urinary disorders | ||
| Renal failure | 1/12 (8.3%) | |
| Respiratory, thoracic and mediastinal disorders | ||
| Pneumonia | 1/12 (8.3%) | |
| Respiratory failure | 1/12 (8.3%) | |
| Vascular disorders | ||
| Cyanosis | 1/12 (8.3%) | |
| Hypertension | 1/12 (8.3%) | |
Other (Not Including Serious) Adverse Events |
||
| Control and/or Onartuzumab Treatment | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/12 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
| Name/Title | Medical Communications |
|---|---|
| Organization | Hoffmann-La Roche |
| Phone | 800-821-8590 |
| genentech@druginfo.com |
- GO29646
- 2014-005438-69