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

NCT02488330 | Completed Phase 3 Results

• 2 other identifiers: GO296462014-005438-69
• Study Type: interventional
• Target: 12
• Locations: 8 countries
• Sites: 10

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.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline through the end of trial (approximately 3 years)

Study Arms (1)

Control and/or Onartuzumab treatment

EXPERIMENTAL

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; Drug: Bevacizumab; Drug: Erlotinib

Interventions

Onartuzumab DRUG

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).

Control and/or Onartuzumab treatment

Bevacizumab DRUG

All participants will continue on the same dose and schedule of control treatment (bevacizumab) as specified in their respective P-trial.

Also known as: Avastin

Control and/or Onartuzumab treatment

Erlotinib DRUG

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

Also known as: Tarceva

Control and/or Onartuzumab treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (10)

Hopital Roger Salengro

Lille, 59037, France

Location

Azienda Ospedaliero Universitaria San Giovanni Battista Di Torino

Turin, Piedmont, 10126, Italy

Location

National Hospital Organization Shikoku Cancer Center

Ehime, 791-0280, Japan

Location

Rigas Austrumu Kliniska Universitates slimnica, Latvijas Onkologijas centrs

Riga, LV 1079, Latvia

Location

Ivanovo Regional Oncology Dispensary

Ivanovo, 153040, Russia

Location

Clin Hospital Center - Kragujevac; Pulmonary Diseases

Kragujevac, 34000, Serbia

Location

University of the Witwatersrand Research

Johannesburg, 2193, South Africa

Location

Sandton Oncology Medical Group

Sandton, 2196, South Africa

Location

Hospital Univ Vall d'Hebron; Servicio de Oncologia

Barcelona, 08035, Spain

Location

HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia

Madrid, 28050, Spain

Location

MeSH Terms

Interventions

onartuzumab; Bevacizumab; Erlotinib Hydrochloride

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2015
• First Posted: July 2, 2015
• Study Start: August 27, 2015
• Primary Completion: June 29, 2018
• Study Completion: June 29, 2018
• Last Updated: July 23, 2019
• Results First Posted: July 23, 2019

Record last verified: 2019-07

Locations

SE (1); ES (2); JP (1); RU (1); LA (1); FR (1); IT (1); ZA (2)