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Chemotherapy (FID-007) for Cancer
Study Summary
This trial will study the side effects and best dose of FID-007, a form of the chemotherapy drug paclitaxel packaged using a PEOX polymer. This polymer may allow the drug to reach deeper into tumors and less into normal cells.
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 2023 Phase 2 trial • 2 Patients • NCT03477396Trial Design
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Who is running the clinical trial?
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- My kidney function is within the required range for the trial.I have brain metastasis but am stable after treatment and not on steroids.I am a woman who can have children and my pregnancy test was negative.I have had 3 or fewer chemotherapy treatments for my advanced disease.I have never been treated with paclitaxel or nab-paclitaxel.I have recovered from side effects of my previous cancer treatments.I finished my last cancer treatment at least 4 weeks ago.I haven't had serious heart issues, strokes, or seizures in the last 6 months.I am on long-term medication that weakens my immune system.I am on blood thinners like warfarin or low molecular weight heparins.I have heart rhythm problems or my EKG shows a QTc over 480 msec.I am receiving paclitaxel as my first treatment for cancer that has spread.I have active hepatitis B or C.I am able to care for myself but may not be able to do heavy physical work.My advanced cancer does not respond to standard treatments, or there are none, and paclitaxel is suitable for me.I do not have severe nerve damage in my hands or feet.I am using effective birth control if I am of childbearing potential.I do not have an active infection, including HIV.I do not have major organ issues or serious mental health conditions.My cancer can be measured or evaluated by specific criteria.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Group 1: Treatment (FID-007)
- 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
What is the upper limit of enrollees for this research trial?
"Affirmative. Clinicaltrials.gov records elucidate that this medical experiment commenced recruitment on May 25th 2018 and is still ongoing; 36 volunteers are needed across two sites."
What potential risks do participants in a Pharmacokinetic Study face?
"As the first stage of a clinical trial, there is only limited evidence available to support this drug's efficacy and safety; thus it received an assessment score of 1."
Are there any additional experiments which assess the absorption, distribution, metabolism and excretion of medications?
"At present, there are 832 clinical studies examining Pharmacokinetic Study with 227 of them in Phase 3. South Australia's Adelaide is hosting a handful of these trials, though 45681 sites around the globe are running experiments for Pharmacokinetic Study."
Are individuals able to participate in this clinical trial at the moment?
"Yes, the information located on clinicaltrials.gov substantiates that this investigation is presently enrolling participants. It was initially published on May 25th 2018 and its most recent update occurred on November 12th 2022. A total of 36 patients need to be recruited from 2 different medical sites."
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