Your session is about to expire
← Back to Search
Monoclonal Antibodies
Trastuzumab Emtansine Safety for Cancer
Phase 2
Recruiting
Research Sponsored by Genentech, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 30 days after last dose of study drug administration (up to approximately 14 years)
Awards & highlights
Study Summary
This trial is for people who have been receiving treatment with either trastuzumab emtansine or a combination of it with other anti-cancer therapies, and who are still benefiting from the treatment. The purpose of the trial is to continue to monitor the safety of the treatment.
Who is the study for?
This trial is for cancer patients who were previously treated with Trastuzumab Emtansine alone or in combination with other therapies in a related study and are still benefiting. They must not have severe heart issues, uncontrolled diseases, recent major surgeries, current pregnancy/lactation, certain drug allergies, high-grade peripheral neuropathy, or specific adverse reactions from previous treatments.Check my eligibility
What is being tested?
The trial continues treatment with Trastuzumab Emtansine for those showing benefits from prior studies. It's an open-label extension meaning everyone knows what treatment they're getting. The aim is to assess long-term safety of the drug used alone or with other anti-cancer agents like Paclitaxel and Atezolizumab.See study design
What are the potential side effects?
Possible side effects include allergic reactions to medication components, liver problems indicated by yellow skin/eyes (jaundice), tiredness (fatigue), nausea/vomiting, low blood cell counts leading to increased infection risk or bleeding tendencies, nerve damage causing numbness/pain (neuropathy), and heart issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to 30 days after last dose of study drug administration (up to approximately 14 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 30 days after last dose of study drug administration (up to approximately 14 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Percentage of Participants With Adverse Events Leading to Study Treatment Discontinuation or Dose Reduction
Trial Design
1Treatment groups
Experimental Treatment
Group I: Trastuzumab EmtansineExperimental Treatment6 Interventions
Participants will receive trastuzumab emtansine either as a single agent or in combination with other anti-cancer therapy (atezolizumab, paclitaxel, trastuzumab and docetaxel). Participants will receive the same dose and schedule on Cycle 1, Day 1 at which it was given at the end of the parent study. Study drug will be administered in 21-day cycles or weekly, depending on the schedule used in the parent study. Participants will receive study treatment until disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2017
Completed Phase 3
~5860
Paclitaxel
2011
Completed Phase 4
~5380
Pertuzumab
2014
Completed Phase 3
~7500
Trastuzumab
2014
Completed Phase 4
~5190
Docetaxel
1995
Completed Phase 4
~5620
Trastuzumab Emtansine
2016
Completed Phase 3
~5630
Find a Location
Who is running the clinical trial?
Genentech, Inc.Lead Sponsor
1,540 Previous Clinical Trials
567,179 Total Patients Enrolled
Hoffmann-La RocheIndustry Sponsor
2,430 Previous Clinical Trials
1,088,702 Total Patients Enrolled
Clinical TrialsStudy DirectorGenentech, Inc.
2,201 Previous Clinical Trials
888,012 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any severe, uncontrolled illnesses.I have not had major surgery or a serious injury in the last 28 days.I am willing to use effective birth control during and after the study.My cancer has worsened despite being on trastuzumab emtansine.I was in a control group for a previous study and my condition worsened, now I can start a new treatment.My doctor believes I could benefit from more trastuzumab emtansine treatment.I will use condoms if my partner is pregnant.I have not taken any experimental cancer treatments since my last study drug dose.I have severe nerve pain or tingling.I haven't had serious heart issues like heart failure or a heart attack in the last 6 months.I have completed or am continuing trastuzumab emtansine treatment within the last 6 weeks.I have severe trouble breathing or need oxygen all the time.
Research Study Groups:
This trial has the following groups:- Group 1: Trastuzumab Emtansine
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What medical conditions does Trastuzumab help alleviate?
"Trastuzumab is a typical course of treatment for metastatic bladder cancer and can also be used in the management of other diseases such as inflammatory breast cancer, small cell lung cancer, and advanced directives."
Answered by AI
Are there any precedent inquiries that have implemented Trastuzumab for medical research?
"Currently, there are 1,516 clinical trials examining trastuzumab with 390 in Phase 3. Seattle is the primary hub running these studies; however, 81493 locations are offering this medication to patients."
Answered by AI
Has Trastuzumab been granted clearance from the Food and Drug Administration?
"Due to its status as a Phase 2 trial, with some safety data but no efficacy information, Trastuzumab received a score of 2."
Answered by AI
Are there still opportunities for patients to join this medical experiment?
"Clinicaltrials.gov data confirms that this medical trial is still open for recruitment, having first been posted on October 16th 2008 and most recently updated November 16th 2022."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger