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An Extension Study to Provide Continued Avastin Therapy to Patients With Solid Tumours Who Were Previously Enrolled in a Roche/Genentech Sponsored Study

This study is currently recruiting participants.
Verified October 2016 by Hoffmann-La Roche
Sponsor:
ClinicalTrials.gov Identifier:
NCT01588184
First Posted: April 30, 2012
Last Update Posted: October 4, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
This single-arm, open-label, multicentre extension study will provide continued Avastin [bevacizumab] therapy to patients with solid tumours who were previously enrolled in a Roche/Genentech sponsored study and who derived benefit from the Avastin therapy. Patients will receive the same dose and regimen as used in the previous parent trial and continue this treatment until disease progression or unacceptable toxicity.

Condition Intervention Phase
Neoplasms Drug: bevacizumab [Avastin] Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Multicentre Extension Study of Bevacizumab Administered as Single Agent or in Combination With Other Anticancer Therapies in Patients on Study Treatment With Bevacizumab at the End of a F. Hoffmann-La Roche and/or Genentech Sponsored Study

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety: Incidence of Adverse Events [ Time Frame: Approximately 5 years ]

Estimated Enrollment: 200
Study Start Date: July 2012
Estimated Study Completion Date: May 2024
Estimated Primary Completion Date: May 2024 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: bevacizumab [Avastin]
7.5 or 15 mg/kg intravenously every 21 days, or 5 or 10 mg/kg intravenously every 14 days until disease progression or unacceptable toxicity

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Adult patients, >/=18 years of age
  • Patients with solid tumours
  • Patient is treated with Avastin at the end of a Roche/Genentech sponsored parent trial and continues to have benefit from Avastin treatment
  • Eligible for continuation of Avastin treatment at the end of a parent trial
  • Able to comply with this extension study protocol (MO25757)

Exclusion Criteria:

  • Evidence of disease progression
  • Evidence of any adverse event potentially attributable to Avastin, for which permanent treatment discontinuation is recommended
  • A treatment interruption with Avastin of more than 42 days since the last administration of Avastin in a parent trial
  • Any other disease that would put the patient at high risk for treatment-related complications
  Contacts and Locations
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): NCT01588184


Contacts
Contact: Reference Study ID Number: MO25757 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global.rochegenentechtrials@roche.com

  Show 72 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01588184     History of Changes
Other Study ID Numbers: MO25757
2011-002009-31 ( EudraCT Number )
First Submitted: April 26, 2012
First Posted: April 30, 2012
Last Update Posted: October 4, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents