An Extension Study to Provide Continued Bevacizumab Therapy to Participants With Solid Tumors Who Were Previously Enrolled in a Roche/Genentech Sponsored Study

Roche

Status and phase: Completed; Phase 4

Conditions: Neoplasms

Treatments: Drug: Bevacizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01588184

MO25757

2011-002009-31 (EudraCT Number)

Details and patient eligibility

About

This single-arm, open-label, multicenter extension study will provide continued bevacizumab therapy to participants with solid tumors who were previously enrolled in a Roche/Genentech sponsored study and who derived benefit from the bevacizumab therapy. Participants will receive the same dose and regimen of bevacizumab as used in the previous parent trial and continue this treatment until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.

Enrollment: 95 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant is treated with bevacizumab at the end of the Roche/Genentech sponsored parent trial and continues to have benefit as judged by the investigator
• Eligible for continuation of bevacizumab treatment at the end of a parent trial, according to parent trial protocol
• Able to comply with this extension study protocol (MO25757)

Exclusion criteria

• Evidence of disease progression assessed according to parent trial protocol during the screening phase for this extension study
• Evidence of any adverse event potentially attributable to bevacizumab, for which the local label recommends permanent discontinuation
• A treatment interruption with bevacizumab of more than 42 days since the last administration of bevacizumab in the parent trial
• Evidence of any other disease that would put the participant at high risk for treatment-related complications

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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95 participants in 6 patient groups

Breast Cancer

Experimental group

Description:

Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.

Treatment:

Drug: Bevacizumab

Ovarian Cancer or Peritoneal Carcinoma

Experimental group

Description:

Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.

Treatment:

Drug: Bevacizumab

Renal Cell Carcinoma

Experimental group

Description:

Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.

Treatment:

Drug: Bevacizumab

Colorectal Cancer

Experimental group

Description:

Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.

Treatment:

Drug: Bevacizumab

Non-Squamous, Non-Small Cell Lung Cancer

Experimental group

Description:

Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.

Treatment:

Drug: Bevacizumab

Glioblastoma Multiforme

Experimental group

Description:

Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.

Treatment:

Drug: Bevacizumab