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OBI-3424 for Solid Cancers
Study Summary
This trial is testing a new drug to see if it is safe and effective.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- I have liver cancer.I am fully active or restricted in physically strenuous activity but can do light work.My liver function tests are within the required range.My kidneys work well enough (creatinine clearance over 30 mL/min).I have had cancer before, but it was either skin cancer that didn't spread, cancer that stayed in place, or a type that won't affect this study.I have a tumor with an AKR1C3 score of ≥ 100, and it's either pancreatic cancer or another solid tumor type.I am willing and able to follow the study's requirements.I have not fully recovered from a major surgery done within the last 4 weeks.I haven't had cancer treatments like radiation or chemotherapy in the last 3 weeks.I am 18 years old or older.My blood counts meet the required levels for treatment.I understand the study's risks and have signed the consent form.I haven't taken naproxen 48 hours before or after my OBI-3424 dose.I do not have any ongoing serious infections needing treatment.I am not pregnant or breastfeeding.I am not taking strong medications that affect liver enzymes.I have had radiation therapy to over a quarter of my bone marrow.My brain metastases are treated and stable for 4 weeks, and I don't have leptomeningeal disease.I have recovered from previous treatment side effects.My cancer is advanced, cannot be surgically removed, and no standard treatments are effective anymore.
- Group 1: Cohort expansion phase
- Group 2: Dose escalation phase
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Are there any opportunities to join this medical experiment currently available?
"The details on clinicaltrials.gov suggest that this medical trial is taking applications from patients, having first been posted on June 7th 2018 and most recently updated on October 17th 2022."
Have any other research efforts included OBI-3424?
"Currently, two clinical tests are actively examining OBI-3424 with none in their final stage. The majority of trials for this drug are taking place in New Brunswick, NJ but there is a total 126 sites participating."
How many healthcare facilities are participating in the clinical trial?
"Five clinical trial sites are operating for this research. These include the USC Norris Comprehensive Cancer Center in Los Angeles, Ohio State University Comprehensive Cancer Centre in Columbus and Scripps Clinic Torrey Pines La Jolla, with two other medical hubs also participating."
Is this trial a pioneering endeavor in its field?
"OBI-3424 has been the subject of clinical trials since 2018, when it was initially researched by OBI Pharma. After a successful Phase 1 and 2 trial which included 104 participants in its sample size, two additional studies have been initiated across 65 cities and one nation."
What is the recruitment capacity for this trial?
"To successfully initiate this medical trial, OBI Pharma Inc. must recruit a total of 104 patients that meet the inclusion criteria. The sponsor will be managing multiple sites across the United States including USC Norris Comprehensive Cancer Center in Los Angeles and Ohio State University Comprehensive Cancer Center in Columbus."
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