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 May 2013 by Hoffmann-La Roche
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01588184
First received: April 26, 2012
Last updated: May 23, 2013
Last verified: May 2013
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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 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
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 |
Locations
| Czech Republic | |
| Recruiting | |
| Olomouc, Czech Republic, 775 20 | |
| Estonia | |
| Not yet recruiting | |
| Tallinn, Estonia, 13419 | |
| France | |
| Recruiting | |
| Dechy, France, 59187 | |
| Recruiting | |
| Lyon, France, 69373 | |
| Recruiting | |
| Toulouse, France, 31059 | |
| Italy | |
| Recruiting | |
| Catania, Italy, 95100 | |
| Recruiting | |
| Pisa, Italy, 56124 | |
| Recruiting | |
| Prato, Italy, 59100 | |
| Recruiting | |
| S Fermo Della Battaglia, Italy, 22020 | |
| Korea, Republic of | |
| Recruiting | |
| Kyunggi-do, Korea, Republic of, 411-769 | |
| Recruiting | |
| Seoul, Korea, Republic of, 110-744 | |
| Mexico | |
| Active, not recruiting | |
| Leon, Mexico, 37000 | |
| Not yet recruiting | |
| Mexico City, Mexico, 06760 | |
| Netherlands | |
| Recruiting | |
| Den Haag, Netherlands, 2504 LN | |
| Recruiting | |
| Nijmegen, Netherlands, 6525 GA | |
| Russian Federation | |
| Active, not recruiting | |
| Irkutsk, Russian Federation, 664035 | |
| Active, not recruiting | |
| Moscow, Russian Federation, 143423 | |
| Completed | |
| Moscow, Russian Federation, 125284 | |
| Active, not recruiting | |
| Moscow, Russian Federation, 117837 | |
| Slovakia | |
| Active, not recruiting | |
| Kosice, Slovakia, 04001 | |
| Spain | |
| Recruiting | |
| Barakaldo, Vizcaya, Spain, 48903 | |
| Recruiting | |
| Burgos, Spain, 09006 | |
| Recruiting | |
| Madrid, Spain, 28040 | |
| United Kingdom | |
| Recruiting | |
| Cambridge, United Kingdom, CB2 2QQ | |
| Recruiting | |
| Rhyl, United Kingdom, LL18 5UJ | |
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: | May 23, 2013 |
| Health Authority: | Czech Republic: State Institute for Drug Control |
Additional relevant MeSH terms:
|
Neoplasms Bevacizumab Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances |
Physiological Effects of Drugs Pharmacologic Actions Growth Inhibitors Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013