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An Extension Study of Onartuzumab in Participants With Solid Tumors on Study Treatment Previously Enrolled in a Company Sponsored Study

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ClinicalTrials.gov Identifier: NCT02488330
Recruitment Status : Completed
First Posted : July 2, 2015
Results First Posted : July 23, 2019
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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
Solid Tumor Drug: Onartuzumab Drug: Bevacizumab Drug: Erlotinib Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


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 Name: Avastin

Drug: Erlotinib
All participants will continue on the same dose and schedule of control treatment (erlotinib) as specified in their respective P-trial.
Other Name: Tarceva




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
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France
Hopital Roger Salengro
Lille, France, 59037
Italy
Azienda Ospedaliero Universitaria San Giovanni Battista Di Torino
Torino, Piemonte, Italy, 10126
Japan
National Hospital Organization Shikoku Cancer Center
Ehime, Japan, 791-0280
Latvia
Rigas Austrumu Kliniska Universitates slimnica, Latvijas Onkologijas centrs
Riga, Latvia, LV 1079
Russian Federation
Ivanovo Regional Oncology Dispensary
Ivanovo, Russian Federation, 153040
Serbia
Clin Hospital Center - Kragujevac; Pulmonary Diseases
Kragujevac, Serbia, 34000
South Africa
University of the Witwatersrand Research
Johannesburg, South Africa, 2193
Sandton Oncology Medical Group
Sandton, South Africa, 2196
Spain
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
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
  Study Documents (Full-Text)

Documents provided by Hoffmann-La Roche:
Study Protocol  [PDF] August 17, 2017
No Statistical Analysis Plan (SAP) exists for this study.

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02488330    
Other Study ID Numbers: GO29646
2014-005438-69 ( EudraCT Number )
First Posted: July 2, 2015    Key Record Dates
Results First Posted: July 23, 2019
Last Update Posted: July 23, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Neoplasms
Bevacizumab
Erlotinib Hydrochloride
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action