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Tyrosine Kinase Inhibitor
Trastuzumab for Bladder Cancer
Phase 2
Waitlist Available
Research Sponsored by Genentech, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Life expectancy greater than or equal to (≥) 12 weeks
Histologically documented metastatic cancer (solid tumors, not including hematologic malignancies)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the date of first study treatment until disease progression or death from any cause, whichever occurs first (up to approximately 9 years)
Awards & highlights
Study Summary
This trial will test six different treatment regimens on people with solid tumors that can't be treated otherwise.
Eligible Conditions
- Bladder Cancer
- Salivary Gland Cancer
- Tumors
- Solid Tumors
- Biliary Cancers
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You are expected to live for at least 12 more weeks.
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You have cancer that has spread to other parts of your body, except for blood cancer.
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You have already received the standard first-line treatment for your cancer, and your doctor believes that participating in this trial is the best option for you. There are no other available treatments that can help you, or your doctor believes that they are not suitable for you.
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You have not been treated with the study drug or any other drug that works in the same way.
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You have a disease that can be measured by a specific medical assessment tool called RECIST v1.1.
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You are able to do most of your daily activities without help or with little help (ECOG score of 0 or 1). If you are participating in the atezolizumab arm, your ECOG score must be confirmed within 7 days before treatment starts, and this information must be entered into the system before you can receive the treatment.
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Your blood, kidney, and liver must be functioning properly according to the study's standards.
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You must use birth control or choose to not have sex as described in the study instructions.
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You are taking both Trastuzumab and Pertuzumab medications.
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You have cancer in the bile duct, salivary gland, or bladder, and a lab test has shown that you have too many copies of the HER2 gene. The lab that did the test is certified by the government.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the date of first study treatment until disease progression or death from any cause, whichever occurs first (up to approximately 9 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the date of first study treatment until disease progression or death from any cause, whichever occurs first (up to approximately 9 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 Atezolizumab-Treated Participants With Tissue Tumor Mutational Burden (tTMB) ≥16 Mutations/Mb With Overall Response, as Assessed by the Independent Review Committee (IRC)
Percentage of Participants in All Tumor-Pathway Cohorts With Overall Response, as Assessed by the Investigator
Secondary outcome measures
Duration of Response
Percentage of Atezolizumab-Treated Participants with Blood Tumor Mutational Burden (bTMB) ≥16 Mutations With Overall Response, as Assessed by the IRC
Percentage of Atezolizumab-Treated Participants with tTMB ≥10 Mutations/Mb and <16 Mutations/Mb With Overall Response, as Assessed by the Investigator
+4 moreTrial Design
7Treatment groups
Experimental Treatment
Group I: VismodegibExperimental Treatment1 Intervention
Participants will receive vismodegib 150 mg orally once daily in each 28-day cycle.
Group II: Vemurafenib Plus CobimetinibExperimental Treatment2 Interventions
Participants will receive vemurafenib 960 mg orally twice daily (BID) in each 28-day cycle; and cobimetinib 60 mg orally once daily for 21 days on and 7 days off in each 28-day cycle.
Group III: VemurafenibExperimental Treatment1 Intervention
Participants will receive vemurafenib 960 mg orally twice daily (BID) in each 28-day cycle.
Group IV: Trastuzumab Plus PertuzumabExperimental Treatment2 Interventions
Participants will receive trastuzumab 8 milligrams per kilogram (mg/kg) intravenous (IV) infusion as loading dose, followed by 6 mg/kg IV infusion every 3 weeks; and pertuzumab 840 mg IV infusion as loading dose, followed by 420 mg IV infusion every 3 weeks.
Group V: ErlotinibExperimental Treatment1 Intervention
Participants will receive erlotinib 150 mg orally once daily in each 28-day cycle.
Group VI: AtezolizumabExperimental Treatment1 Intervention
Participants will receive atezolizumab 1200 mg IV infusion every 3 weeks.
Group VII: AlectinibExperimental Treatment1 Intervention
Participants will receive alectinib 600 mg orally BID in each 28-day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vismodegib
2015
Completed Phase 4
~1880
Trastuzumab
2014
Completed Phase 4
~5190
Pertuzumab
2014
Completed Phase 3
~7500
Erlotinib
2011
Completed Phase 4
~2290
Vemurafenib
2015
Completed Phase 3
~3100
Cobimetinib
2017
Completed Phase 3
~2660
Alectinib
2015
Completed Phase 3
~2400
Atezolizumab
2017
Completed Phase 3
~5860
Find a Location
Who is running the clinical trial?
Genentech, Inc.Lead Sponsor
1,539 Previous Clinical Trials
567,016 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,200 Previous Clinical Trials
887,849 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are entities currently being enrolled into this research endeavor?
"This clinical trial is no longer actively seeking participants, having been first posted on April 14th 2014 and last edited on September 26th 2022. If you are searching for alternative studies, there are currently 2767 medical trials recruiting patients with cancer and 614 specifically related to Trastuzumab."
Answered by AI
What past investigations have been conducted concerning Trastuzumab?
"Trastuzumab, was first evaluated in clinical trials at Ospedale di Circolo e Fondazione Macchi back in 1999. Since then the drug has been tested and trialled over 978 times. At present, 614 studies are actively recruiting patients with many of these taking place within Zion Arizona."
Answered by AI
To what extent may Trastuzumab present a risk to patients?
"Thus far, there is evidence that trastuzumab can be safely administered to patients in this Phase 2 trial; therefore, it was given a rating of 2 on our safety scale."
Answered by AI
How many participants is the research team looking to recruit?
"This clinical trial is no longer seeking new candidates. It was first posted on April 14th 2014 and the latest update was September 26th 2022. Considering alternative studies, 2767 cancer-related trials are currently open to participants; 614 of them involve Trastuzumab treatments."
Answered by AI
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