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Study Summary
This trial is testing a new drug, MEDI1191, given directly into tumors, either alone or with the existing drug durvalumab, to see if it is effective against solid tumors.
- Solid Tumors
- Cancer
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 867 Patients • NCT03084471Trial Design
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Who is running the clinical trial?
Frequently Asked Questions
How many participants is the research team recruiting for this trial?
"This medical trial concluded its recruitment process. It was initially posted on May 8th 2019 and last updated on November 30th 2022. However, there are still 2998 trials actively enrolling those with malignancies and 333 studies accepting participants for MEDI1191 specifically."
Do I meet the requirements to join this clinical experiment?
"This clinical trial is recruiting 61 patients aged 18 to 101 who have been diagnosed with malignancies. Additionally, there are strict prerequisites for enrollment including ECOG 0-1 status and adequate organ function within 2 weeks of receiving treatment. Participants must also cease using certain medications 7 days prior to the first dose of MEDI1191, provide histological or cytological confirmation of their condition, have progressed on at least one line of standard systemic therapy in the recurrent/metastatic setting., use an effective form contraception from screening through 3 months after receipting the final dose of investigational product (if applicable) , show evidence that they possess"
How widespread is the administration of this trial?
"Presently, this trial has 7 different sites across the country. These include centres located in The Bronx, Newport Beach and La Jolla amongst other locations. It is paramount to select a clinic that offers convenient access for participants if you choose to join the study."
Does this clinical experiment cater to individuals over the age of 45?
"This clinical trial is open to anyone between 18 and 101 years of age. There are 378 trials specifically for those under 18, while 3084 studies are targeting patients over the age of 65."
What purpose is this clinical research aiming to fulfill?
"The primary outcome of the trial, which will be assessed within a 90 day period from initial informed consent, is Objective Response Rate (ORR) in patients receiving either MEDI1191 or Durvalumab. Secondary outcomes include Area Under Concentration-Time Curve (AUC), Maximum Observed Concentration (Cmax), and Progression Free Survival (PFS). PK endpoints for MEDI1191 and durvalumab concentrations in serum at multiple time points after administration are also under evaluation."
Has MEDI1191 received clearance from the United States Food and Drug Administration?
"MEDI1191 was rated a 1 on our safety scale due to the initial Phase 1 trial, which provided limited evidence for both its efficacy and potential risks."
What pathologies is MEDI1191 usually prescribed to address?
"MEDI1191 is an effective treatment option for individuals suffering from unresectable stage III non-small cell lung cancer, those with metastatic ureter urothelial carcinoma who have not received previous treatments and more."
Are there any past experiments that have utilized MEDI1191?
"MEDI1191 first entered clinical trials in 2010 at City of Hope. Thus far, 106 studies have been completed and 333 are currently ongoing; the majority of these latter investigations take place within Bronx, New york."
Are there any openings for participants in this experiment?
"This clinical trial is not presently selecting participants. It was first advertised on May 8th, 2019 and last modified November 30th of 2022. If you are interested in other trials, 2998 trials related to malignancies are currently enrolling patients while 333 studies concerning MEDI1191 have available openings for research subjects."
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