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Tiny paclitaxel particles aim to hit tumors harder

NCT ID NCT03537690

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial tests a new form of the chemotherapy drug paclitaxel, called FID-007, in 50 people with advanced solid tumors that have stopped responding to other treatments. The drug is wrapped in a special polymer to make it smaller, which may help it reach deeper into tumors while sparing healthy cells. The main goals are to find the safest dose and to watch for side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
FID-007 (a nano-encapsulated form of the chemotherapy drug paclitaxel)
What this could lead to
If it works, this could provide a new treatment option for people with advanced solid tumors that no longer respond to standard therapies.
What could go wrong
This is a very early (Phase 1) trial with only 50 participants, so the main goal is safety, not effectiveness. The drug may still cause significant side effects or fail to shrink tumors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

50 people

The number who actually took part.

Started

May 2018

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients must have histopathologically /cytologically confirmed advanced solid tumor which is refractory to standard therapeutic options, or for which there are no standard therapeutic options, or for whom paclitaxel is an appropriate palliative treatment option (patients for whom paclitaxel or nab-paclitaxel are established treatment options with a proven survival benefit in first line will be excluded) * Patients must have Eastern Cooperative Oncology Group (ECOG) performance status ? 2 * Patient must have recovered from any toxic effects of previous chemotherapy, targeted therapy or radiotherapy as judged by the investigator to ? grade 1 * Previous chemotherapy/radiotherapy/targeted therapy should have been completed at least 4 weeks prior to start of FID-007 administration * Patients must have an estimated life expectancy of at least 3 months * Female patients of child bearing potential must have negative serum pregnancy test at screening * Sexually active women, unless surgically sterile (at least 6 months prior to study drug administration) or postmenopausal for at least 12 consecutive months, must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives \[any hormonal method in conjunction with a secondary method\], intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile \[at least 6 months prior to study drug administration\] sexual partner) for at least 4 weeks prior to study drug administration, during study and up to 30 days or till next chemotherapy cycle; cessation of birth control after this point should be discussed with a responsible physician; investigator will discuss with patient on the above points and the patient agreement will be documented in the source document; the investigator should ensure that the patient is using an effective method of avoiding pregnancy as per protocol; in case of male patients: either patient partners or patients themselves must use an effective method of avoiding pregnancy for at least 4 weeks prior to study drug administration, during study and up to 30 days or till next chemotherapy cycle * Patients must agree, as part of the informed consent, to provide blood for pharmacokinetics analysis * Absolute neutrophil count (ANC) ? 1500/mm\^3 * Platelet count ? 100,000/mm\^3 * Hemoglobin ? 8 g/dL * 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 * Total bilirubin ? 1 X ULN (subjects with Gilbert?s disease can have bilirubin of up to 1.5 X ULN) * Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) \< 3 X ULN * Patients in the dose escalation phase of the study must have measurable or evaluable disease according to RECIST 1.1 criteria Exclusion Criteria: * Patients who have had hypersensitivity to paclitaxel or any of its excipients * Patients must not have received more than 3 prior lines of cytotoxic chemotherapy for advanced disease; treatment with targeted agents or biologic agents such as antibodies as single agents will not count as a line of cytotoxic chemotherapy * Patient must not have had prior treatment with paclitaxel or nab-paclitaxel * Patients must not have serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders, which could compromise the subject's safety or the study data integrity; these include, but are not limited to: history of interstitial lung disease, slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies * Patient must not have a history of the following within 6 months prior to cycle 1 day 1: a myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) class III-IV heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or electrocardiogram (ECG) abnormality, cerebrovascular accident, transient ischemic attack, or seizure disorder * Patients who have pre-existing motor or sensory neuropathy of a severity ? grade 1 by CTCAE v4.0 criteria * Patients who have known active hepatitis B or C * Patients who have active infection including known human immunodeficiency virus (HIV) infection * Patients who have concurrent conditions resulting in immune compromise, including chronic treatment with corticosteroids or other immunosuppressive agents * Patients who are on therapeutic anticoagulation with warfarin; patients on therapeutic doses of with low molecular weight heparins are eligible * Patients who have ongoing cardiac dysrhythmias, atrial fibrillation, or prolongation of corrected QTc interval to \> 480 msec on 2 out of 3 electrocardiograms (EKGs) (if first EKG has QTc \< 480, no need to repeat, if first EKG has QTc \> 480 repeat twice for a total of 3 EKGs) * Patients who have known brain metastasis; patients whose central nervous system (CNS) metastases have been treated by surgery or radiotherapy, who are no longer on corticosteroids, and who are neurologically stable are eligible * Patients for whom paclitaxel (or nab-paclitaxel) is being used in the curative setting, either adjuvant or neoadjuvant, and patients who would receive paclitaxel (or nab-paclitaxel) as first line therapy in a tumor type in which paclitaxel (or nab-paclitaxel) has a proven survival benefit for metastatic disease

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Hoag Memorial Hospital

    Newport Beach, California, 92663, United States

  • Los Angeles General Medical Center

    Los Angeles, California, 90033, United States

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033, United States

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