An Extension Study of Onartuzumab in Participants With Solid Tumors on Study Treatment Previously Enrolled in a Company Sponsored Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02488330|
Recruitment Status : Completed
First Posted : July 2, 2015
Results First Posted : July 23, 2019
Last Update Posted : July 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor||Drug: Onartuzumab Drug: Bevacizumab Drug: Erlotinib||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Multicenter Extension Study of Onartuzumab in Patients With Solid Tumors on Study Treatment Previously Enrolled in an F.Hoffmann-la Roche- and/or Genentech- Sponsored Study|
|Actual Study Start Date :||August 27, 2015|
|Actual Primary Completion Date :||June 29, 2018|
|Actual Study Completion Date :||June 29, 2018|
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.
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).
All participants will continue on the same dose and schedule of control treatment (bevacizumab) as specified in their respective P-trial.
Other Name: Avastin
All participants will continue on the same dose and schedule of control treatment (erlotinib) as specified in their respective P-trial.
Other Name: Tarceva
- Percentage of Participants With Serious Adverse Events Considered Related to Onartuzumab [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02488330
|Hopital Roger Salengro|
|Lille, France, 59037|
|Azienda Ospedaliero Universitaria San Giovanni Battista Di Torino|
|Torino, Piemonte, Italy, 10126|
|National Hospital Organization Shikoku Cancer Center|
|Ehime, Japan, 791-0280|
|Rigas Austrumu Kliniska Universitates slimnica, Latvijas Onkologijas centrs|
|Riga, Latvia, LV 1079|
|Ivanovo Regional Oncology Dispensary|
|Ivanovo, Russian Federation, 153040|
|Clin Hospital Center - Kragujevac; Pulmonary Diseases|
|Kragujevac, Serbia, 34000|
|University of the Witwatersrand Research|
|Johannesburg, South Africa, 2193|
|Sandton Oncology Medical Group|
|Sandton, South Africa, 2196|
|Hospital Univ Vall d'Hebron; Servicio de Oncologia|
|Barcelona, Spain, 08035|
|HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia|
|Madrid, Spain, 28050|
|Study Director:||Clinical Trials||Hoffmann-La Roche|