A Continuation Study of Herceptin (Trastuzumab) in Participants With Metastatic or Locally Advanced Cancer
|
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. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02721641 |
|
Recruitment Status :
Completed
First Posted : March 29, 2016
Results First Posted : March 31, 2017
Last Update Posted : March 31, 2017
|
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Brief Summary:
This study is designed to provide continued access to intravenous (IV) Herceptin and to evaluate long-term outcomes and overall safety in participants with stable disease and human epidermal growth factor 2 (HER2)-overexpressing metastatic or locally advanced cancer who have completed a prior study with IV Herceptin.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Neoplasms | Drug: Herceptin | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 69 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Single Arm, Multi-Center, International, Continuation Trial of Recombinant Humanized Antibody Herceptin (Trastuzumab) in Patients With HER2-Overexpressing Tumors |
| Study Start Date : | June 1999 |
| Actual Primary Completion Date : | February 2015 |
| Actual Study Completion Date : | February 2015 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Trastuzumab
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Herceptin
Participants with stable disease and HER2-overexpressing metastatic or locally advanced cancer will receive expanded access to IV Herceptin until disease progression, unacceptable toxicity, death, or decision by the investigator or participant to discontinue treatment.
|
Drug: Herceptin
Herceptin will be administered as either 2 milligrams per kilogram (mg/kg) once weekly (first dose as a 4-mg/kg loading dose) or 6 mg/kg every 3 weeks (first dose as an 8-mg/kg loading dose) via IV infusion over 90 minutes.
Other Name: Trastuzumab |
Primary Outcome Measures :
- On-Study Duration of Trial Treatment [ Time Frame: From date of enrollment until death or premature withdrawal (maximum 7.4 years of follow-up) ]
- Number of Participants With Drop in Left Ventricular Ejection Fraction (LVEF) Below 45 Percent (%) [ Time Frame: From date of enrollment until disease progression, death, or premature withdrawal; assessed per investigator discretion (maximum 7.4 years of follow-up) ]
- Number of Participants Withdrawn From Study Because of LVEF Dysfunction [ Time Frame: From date of enrollment until death or premature withdrawal (maximum 7.4 years of follow-up) ]LVEF dysfunction was defined as low LVEF measured on two consecutive assessments, with the second assessment performed after 3 weeks of study medication being withheld. Low LVEF included values less than or equal to 39% or values between 40% and 45% (inclusive) with a decrease of 10 or more percentage points from Baseline.
Information from the National Library of Medicine
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Ongoing participants from any completed global Roche-sponsored Herceptin trial
- Participants enrolled in any Roche-sponsored Herceptin trial who have at least stable disease (or whose disease has not recurred) during Herceptin therapy at the end of the lead-in trial
- Available study termination data (including tumor assessment and laboratory data) on the Case Report Form for the lead-in trial
- Judged eligible by the investigator following a thorough risk/benefit assessment, if signs of chronic heart failure developed during the lead-in trial
Exclusion Criteria:
- Pregnant or nursing women
- Women of childbearing potential unless using effective contraception as determined by the investigator
- Severe dyspnea at rest requiring supplementary oxygen therapy
- Severe uncontrolled systemic disease
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): NCT02721641
Locations
| Australia, New South Wales | |
| Liverpool, New South Wales, Australia, 2170 | |
| Waratah, New South Wales, Australia, 2298 | |
| Australia, Queensland | |
| Brisbane, Queensland, Australia, 4006 | |
| Brisbane, Queensland, Australia, 4066 | |
| Australia, Victoria | |
| Fitzroy, Victoria, Australia, 3065 | |
| Geelong, Victoria, Australia, 3220 | |
| Parkville, Victoria, Australia, 3052 | |
| Belgium | |
| Brussel, Belgium, 1090 | |
| China | |
| Beijing, China, 100021 | |
| Beijing, China, 100142 | |
| France | |
| Marseille, France, 13273 | |
| Germany | |
| Berlin, Germany, 12203 | |
| Göttingen, Germany, 37075 | |
| Hamburg, Germany, 20246 | |
| Heidelberg, Germany, 69120 | |
| Lübeck, Germany, 23538 | |
| Muenchen, Germany, 80637 | |
| Muenchen, Germany, 81377 | |
| Trier, Germany, 54290 | |
| Guatemala | |
| Guatemala City, Guatemala, 01010 | |
| Hungary | |
| Budapest, Hungary, 1122 | |
| Debrecen, Hungary, 4032 | |
| Israel | |
| Ramat Gan, Israel, 5262100 | |
| Korea, Republic of | |
| Bundang City, Korea, Republic of, 463-802 | |
| Seoul, Korea, Republic of, 03080 | |
| Seoul, Korea, Republic of, 120-752 | |
| Seoul, Korea, Republic of, 138-736 | |
| New Zealand | |
| Auckland, New Zealand, 1023 | |
| Panama | |
| Panama City, Panama, 0832-00752 | |
| Poland | |
| Gdansk, Poland, 80-214 | |
| Portugal | |
| Lisboa, Portugal, 1099-023 | |
| Russian Federation | |
| Izhevsk, Russian Federation, 426009 | |
| Moscow, Russian Federation, 115478 | |
| Saint-Petersburg, Russian Federation, 197758 | |
| Serbia | |
| Belgrade, Serbia, 11000 | |
| Spain | |
| Alicante, Spain, 3010 | |
| Barcelona, Spain, 08035 | |
| United Kingdom | |
| Edinburgh, United Kingdom, EH4 2XU | |
| Glasgow, United Kingdom, G12 0YN | |
| London, United Kingdom, SE1 9RT | |
| Nottingham, United Kingdom, NG5 1PB | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Chair: | Clinical Trials | Hoffmann-La Roche |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT02721641 |
| Other Study ID Numbers: |
BO15943 2007-000348-28 ( EudraCT Number ) |
| First Posted: | March 29, 2016 Key Record Dates |
| Results First Posted: | March 31, 2017 |
| Last Update Posted: | March 31, 2017 |
| Last Verified: | February 2017 |
Additional relevant MeSH terms:
|
Trastuzumab Antineoplastic Agents, Immunological Antineoplastic Agents |