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

Sponsor
Hoffmann-La Roche
Study ID
NCT02488330
Phase
PHASE3
Status
Completed

Conditions

  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

First listed
Jul 2, 2015
Start date
Aug 27, 2015
Status verified
Jul 2019
Primary completion
Jun 29, 2018
Completion
Jun 29, 2018

Study Design

Enrollment
12 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Percentage of Participants With Serious Adverse Events Considered Related to Onartuzumab [ Time Frame: Baseline through the end of trial (approximately 3 years) ]

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