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. (see Contacts and Locations)
Verified October 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01588184
First received: April 26, 2012
Last updated: October 20, 2014
Last verified: October 2014
  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 u nacceptable toxicity.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: July 2012
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01588184

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

  Show 43 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01588184     History of Changes
Other Study ID Numbers: MO25757, 2011-002009-31
Study First Received: April 26, 2012
Last Updated: October 20, 2014
Health Authority: Czech Republic: State Institute for Drug Control

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

ClinicalTrials.gov processed this record on October 22, 2014