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RGX-202-01 Combination Therapy for Colorectal Cancer
Study Summary
This trial is testing a new drug, RGX-202-01, to see if it can shrink tumors in people with gastrointestinal cancer. The study will test different doses of the drug to see what is safe and effective. The study will also test the drug in combination with other drugs that are commonly used to treat gastrointestinal cancer.
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.Side effects data
From 2015 Phase 4 trial • 45 Patients • NCT02036424Trial Design
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Who is running the clinical trial?
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- I have a condition that affects how my body absorbs nutrients.I have a history of bleeding disorders or tend to develop blood clots.My heart pumps well, with an ejection fraction of 45% or higher.My blood clotting tests are within normal limits and if on warfarin, my dose is stable with INR <3.5.My organs are functioning well.I have had fluid removed from my abdomen or needed pain medication for it in the last 28 days.I have had bowel blockage or chronic bowel inflammation but not only at diagnosis time.My colorectal cancer is RAS positive and confirmed by lab tests.I have at least one tumor that can be measured.I am 18 years old or older.I have other cancers, but they won't affect this study's results.I do not have serious heart problems.I do not have a DPD deficiency and haven't taken DPD inhibitors in the last 4 weeks.I have a specific genetic variation related to drug processing.My disease did not respond to or came back after standard treatment, or there is no effective standard treatment available.My tumor is confirmed to have a RAS mutation.I've had pembrolizumab or a similar treatment for my colorectal cancer.I have high levels of protein in my urine or nephrotic syndrome.I haven't had severe bleeding or blood clots in the last 6 months, except for tumor surgery.I have active cancer spread to my brain or its coverings.I have been treated with FOLFIRI or a similar medication before.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I have a long-term liver condition.I have had severe wounds, ulcers, or bone fractures that did not heal properly.I am fully active or restricted in physically strenuous activity but can do light work.I may have had treatments with bevacizumab, cetuximab, panitumumab, or their approved alternatives.My cancer is a type of colorectal cancer that has spread or is advanced.I have a muscle disorder diagnosis.My cancer is of small cell, neuroendocrine, or squamous type.I don't have severe side effects from past cancer treatments, except for mild nerve issues or hair loss.I have had only one prior treatment with oxaliplatin for advanced colorectal cancer.My cancer has spread or cannot be removed by surgery.I need treatment with strong medication inhibitors for my condition.
- Group 1: Single agent RGX-202-01 Dose Escalation
- Group 2: RGX-202-01 in combination with FOLFIRI Dose Escalation
- Group 3: Expansion: 2nd Line Colorectal Cancer (CRC) KRAS (+)
- 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
Is this investigation enrolling new participants at present?
"As per the data hosted on clinicaltrials.gov, this particular trial is still recruiting volunteers - it was first published in June of 2018 and its last revision happened on October 27th 2022."
In what circumstances is RGX-202-01 commonly prescribed?
"RGX-202-01 has demonstrated efficacy when employed to treat rectal carcinoma, colorectal carcinoma, and sarcoma."
Are any medical centers in North America offering this research experiment?
"Presently, 5 sites are responsible for running this trial. Locations include Santa Monica, Nashville and New york as well as two additional places. To minimize the amount of travel necessary to partake in the study, selecting a nearby site is recommended."
Are there any other prior studies that have employed RGX-202-01 as a therapeutic agent?
"At present, there are 792 active research projects exploring RGX-202-01 with 212 of those studies in the final phase. There is a total of 37,438 clinical trial sites offering this medication; many of these locations are found in Shanghai."
To what extent does RGX-202-01 pose a risk to those who take it?
"Due to the limited data available on RGX-202-01, our team at Power has given it a score of 1 in terms of safety. This is because this clinical trial is only in Phase 1 and therefore lacks substantial evidence for efficacy or security."
What is the capacity of participation for this clinical experiment?
"Affirmative. According to clinicaltrials.gov, this study is currently enrolling patients, having originally been posted on June 5th 2018 and most recently updated on October 27th 2022. The trial intends to recruit a total of 60 volunteers from five different medical centres."
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