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

NCT ID: NCT02488330

Last Updated: 2019-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-27
• Study Completion Date: 2018-06-29

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Onartuzumab

Intervention Type: 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).

Bevacizumab

Intervention Type: DRUG

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

Erlotinib

Intervention Type: DRUG

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

Interventions

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).

Intervention Type: DRUG

Bevacizumab

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

Intervention Type: DRUG

Erlotinib

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

Intervention Type: DRUG

Other Intervention Names

Avastin; Tarceva

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Hopital Roger Salengro

Lille, , France

Azienda Ospedaliero Universitaria San Giovanni Battista Di Torino

Turin, Piedmont, Italy

National Hospital Organization Shikoku Cancer Center

Ehime, , Japan

Rigas Austrumu Kliniska Universitates slimnica, Latvijas Onkologijas centrs

Riga, , Latvia

Ivanovo Regional Oncology Dispensary

Ivanovo, , Russia

Clin Hospital Center - Kragujevac; Pulmonary Diseases

Kragujevac, , Serbia

University of the Witwatersrand Research

Johannesburg, , South Africa

Sandton Oncology Medical Group

Sandton, , South Africa

Hospital Univ Vall d'Hebron; Servicio de Oncologia

Barcelona, , Spain

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

Madrid, , Spain

Countries

France; Italy; Japan; Latvia; Russia; Serbia; South Africa; Spain

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

2014-005438-69

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GO29646

Identifier Type: -

Identifier Source: org_study_id