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Anti-microtubule agent

Chemotherapy (FID-007) for Cancer

Phase 1
Recruiting
Led By Anthony El-Khoueiry, MD
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Serum creatinine ? 1.5 X upper limit of normal (ULN) OR calculated clearance ? 50 mL/min/1.73 m^2; if using creatinine clearance, actual body weight should be used for calculating creatinine clearance (e.g., using the Cockcroft-Gault formula); for subjects with a body mass index (BMI) > 30 kg/m^2, lean body weight should be used instead
Female patients of childbearing potential must have a negative serum pregnancy test at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

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.

Who is the study for?
This trial is for adults with advanced solid tumors that have spread and don't respond to treatment. They must have acceptable blood counts, organ function, and a life expectancy of at least 3 months. Participants need measurable disease, no severe allergies to paclitaxel, no more than three prior chemotherapy treatments for advanced disease, and cannot be on certain anticoagulants or have serious heart conditions.Check my eligibility
What is being tested?
The study tests FID-007, a new form of the chemotherapy drug paclitaxel encapsulated in PEOX-based polymer which may target tumors more effectively while sparing normal cells. The trial aims to find the safest dose with the fewest side effects by gradually increasing doses among participants.See study design
What are the potential side effects?
Potential side effects include those commonly associated with chemotherapy such as fatigue, nausea, hair loss, nerve damage (neuropathy), low blood cell counts leading to increased infection risk or bleeding tendencies. Specific reactions due to the unique formulation could also occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function is within the required range for the trial.
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I am a woman who can have children and my pregnancy test was negative.
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I am able to care for myself but may not be able to do heavy physical work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose limiting toxicity (DLT) of PEOX-based polymer encapsulated paclitaxel FID-007 (FID-007)
Incidence of adverse events
Secondary outcome measures
Clinical anti-tumor response (Complete Response [CR] and Partial Response [PR])

Side effects data

From 2023 Phase 2 trial • 2 Patients • NCT03477396
100%
Cough
100%
Fatigue
100%
Alanine aminotransferase increased
100%
Aspartate aminotransferase increased
100%
Neutrophil count decreased
100%
White blood cell decreased
100%
Hyponatremia
100%
Alkaline phosphatase increased
100%
Nausea
50%
Dyspnea
50%
Rash acneiform
50%
Alopecia
50%
Hot flashes
50%
Dry skin
50%
Anxiety
50%
Epistaxis
50%
Sore throat
50%
left upper eyelid droop
50%
Anorexia
50%
Constipation
50%
Dyspepsia
50%
Chills
50%
Pain
50%
Edema limbs
50%
blood in stool
50%
Upper respiratory infection
50%
Cholesterol high
50%
Creatinine increased
50%
Lymphocyte count decreased
50%
Platelet count decreased
50%
Hyperglycemia
50%
Hyperkalemia
50%
Hypertriglyceridemia
50%
Hypoalbuminemia
50%
Hypoglycemia
50%
Arthralgia
50%
Osteoporosis
50%
Headache
50%
Memory impairment
50%
Depression
50%
Vomiting
50%
Gastroesophageal reflux disease
50%
Anemia
50%
Diarrhea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Ribociclib, Aromatase Inhibitor)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (FID-007)Experimental Treatment3 Interventions
Participants receive FID-007 IV over 60 minutes on days 1, 8 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor
900 Previous Clinical Trials
1,595,587 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,799 Total Patients Enrolled
Anthony El-Khoueiry, MDPrincipal InvestigatorUniversity of Southern California
5 Previous Clinical Trials
203 Total Patients Enrolled

Media Library

PEOX-based Polymer Encapsulated Paclitaxel FID-007 (Anti-microtubule agent) Clinical Trial Eligibility Overview. Trial Name: NCT03537690 — Phase 1
Cancer Clinical Trial 2023: PEOX-based Polymer Encapsulated Paclitaxel FID-007 Highlights & Side Effects. Trial Name: NCT03537690 — Phase 1
Cancer Research Study Groups: Treatment (FID-007)
PEOX-based Polymer Encapsulated Paclitaxel FID-007 (Anti-microtubule agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03537690 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What purpose do Pharmacokinetic Studies typically serve?

"Pharmacokinetic Study is largely used to halt the spread of neoplasm. It has also been deployed in treating kaposi sarcoma, advance directives, and fallopian tubes cancer."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~6 spots leftby May 2025