Safety Extension Study for Patients Previously Treated with Trastuzumab Emtansine Alone or with Other Cancer Therapies
Sponsor: Genentech, Inc.
ClinicalTrials ID:NCT00781612
This study allows patients who were benefiting from trastuzumab emtansine treatment in a previous study to continue receiving the medication. It aims to ensure the ongoing safety and effectiveness of the treatment for those who were part of earlier research.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
This global study is designed for patients who were receiving trastuzumab emtansine, either alone or with other cancer treatments, in a previous study sponsored by Genentech/Roche. If these patients were benefiting from the treatment when the previous study ended, they can continue their treatment in this extension study to further evaluate its safety.
Eligibility Criteria
Inclusion Criteria
- Completed or are currently receiving trastuzumab emtansine treatment in a previous study and had their last dose within 6 weeks before starting this extension study.
- Were in the control group of a specific previous study and had disease progression during the transition to this extension study.
- The study doctor believes the patient may continue to benefit from the treatment.
- Women who can become pregnant and men with partners who can become pregnant must use effective non-hormonal birth control during the study and for several months after the last dose.
- Men with pregnant partners should use condoms during the pregnancy and should not donate sperm during this time.
Exclusion Criteria
- Had side effects in the previous study that led to stopping trastuzumab emtansine treatment.
- Have ongoing serious side effects from the previous study.
- Experienced disease progression on trastuzumab emtansine treatment in the previous study, except for certain cases.
- Have severe nerve damage or heart problems.
- Have severe breathing difficulties or need continuous oxygen therapy.
- Have uncontrolled serious health conditions.
- Had major surgery or a significant injury within 28 days before joining this study.
- Are currently pregnant or breastfeeding.
- Have received other cancer treatments since the last dose in the previous study.
- Have allergies to trastuzumab emtansine or related treatments.
- Are unable or unwilling to follow the study requirements.
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.
