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Advanced Malignant Solid NeoplasmPhase 1NCT03537690

FID-007 in Treating Participants With Advanced Solid Tumors

A Phase 1 study testing Laboratory Biomarker Analysis, PEOX-based Polymer Encapsulated Paclitaxel FID-007 and Pharmacokinetic Study in people with Advanced Malignant Solid Neoplasm and Refractory Malignant Solid Neoplasm, run by University of Southern California at 3 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This phase I trial studies the side effects and best dose of PEOX-based polymer encapsulated paclitaxel FID-007 (FID-007) in treating participants with malignant neoplasms that have spread to other places in the body and do not respond to treatment. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Laboratory Biomarker Analysis, PEOX-based Polymer Encapsulated Paclitaxel FID-007 and Pharmacokinetic Study
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
3 sitesUnited States
Study dates
25 May 2018to 25 May 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Los Angeles General Medical Center

    Los Angeles, California, 90033

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Hoag Memorial Hospital

    Newport Beach, California, 92663

Other trials in United States

About this study

Official title: A Phase I Study of FID-007 in Patients With Advanced Solid Tumors

This phase I trial studies the side effects and best dose of PEOX-based polymer encapsulated paclitaxel FID-007 (FID-007) in treating participants with malignant neoplasms that have spread to other places in the body and do not respond to treatment. FID-007 is a packaged form of the chemotherapy drug paclitaxel, and uses a polyethylozaxoline (PEOX) polymer which may allow the drug to reach deeper into tumors and less into normal cells by being smaller.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the maximum tolerated dose (MTD) of FID-007 and the recommended phase II dose (RP2D).

II. To determine the pharmacokinetics of paclitaxel, (free and total) in patients treated with FID-007.

SECONDARY OBJECTIVES:

  1. To characterize the safety and tolerability of FID-007 by assessing toxicities per Common Terminology Criteria for Adverse Events (CTCAE) version (v.)4.3.

II. To obtain a preliminary assessment of anti-tumor activity of FID-007 via objective radiologic tumor response using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

EXPLORATORY OBJECTIVES:

  1. To evaluate in a preliminary fashion the serum concentration of total paclitaxel and free paclitaxel, and explore potential associations with serum concentrations, efficacy and toxicity.

OUTLINE: This is a dose escalation study.

Participants receive FID-007 intravenously (IV) over 60 minutes on days 1, 8 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, participants are followed up periodically.

Being tested
Laboratory Biomarker Analysis, PEOX-based Polymer Encapsulated Paclitaxel FID-007, Pharmacokinetic Study

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • PEOX-based Polymer Encapsulated Paclitaxel FID-007Drug

    Also called Paclitaxel in Polyethyloxazoline Polymer; FID-007; FID007 (CN); FID 007; Nanoencapsulated Paclitaxel FID-007

    Given IV

  • Pharmacokinetic StudyOther

    Also called PHARMACOKINETIC, PK Study

    Correlative studies

Study groups in NCT03537690
Study groupRoleWhat they receive
Treatment (FID-007)ExperimentalParticipants 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.
Receives: Other: Laboratory Biomarker Analysis; Drug: PEOX-based Polymer Encapsulated Paclitaxel FID-007; Other: Pharmacokinetic Study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose limiting toxicity (DLT) of PEOX-based polymer encapsulated paclitaxel FID-007 (FID-007)

    Will be evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.03 and summarized by dose level, cycle, organ system and type.

    Measured: After first cycle (28 days)

  2. Incidence of adverse events

    Will be reported using the CTCAE version 4.03.

    Measured: Up to 2 years

Secondary outcomes (1)

  1. Clinical anti-tumor response (Complete Response [CR] and Partial Response [PR])

    Will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2018
  2. Study start25 May 2018
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion25 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03537690
Sponsor's protocol ID
0C-18-2
Other IDs
NCI-2018-00758, 0C-18-2, P30CA014089
Status last verified
Apr 2026
First submitted
15 May 2018
Last updated
29 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Laboratory Biomarker Analysis, PEOX-based Polymer Encapsulated Paclitaxel FID-007 and Pharmacokinetic Study in people with Advanced Malignant Solid Neoplasm and Refractory Malignant Solid Neoplasm, run by University of Southern California at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose limiting toxicity (DLT) of PEOX-based polymer encapsulated paclitaxel FID-007 (FID-007) (time frame: After first cycle (28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03537690.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.

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