FID-007 in Treating Participants With Advanced Solid Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03537690|
Recruitment Status : Recruiting
First Posted : May 25, 2018
Last Update Posted : November 15, 2022
|Condition or disease||Intervention/treatment||Phase|
|Advanced Malignant Solid Neoplasm Refractory Malignant Solid Neoplasm||Other: Laboratory Biomarker Analysis Drug: PEOX-based Polymer Encapsulated Paclitaxel FID-007 Other: Pharmacokinetic Study||Phase 1|
I. 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.
I. 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.
I. 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of FID-007 in Patients With Advanced Solid Tumors|
|Actual Study Start Date :||May 25, 2018|
|Estimated Primary Completion Date :||May 25, 2024|
|Estimated Study Completion Date :||May 25, 2025|
Experimental: Treatment (FID-007)
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.
Other: Laboratory Biomarker Analysis
Drug: PEOX-based Polymer Encapsulated Paclitaxel FID-007
Other Name: Paclitaxel in Polyethyloxazoline Polymer; FID-007; FID007 (CN); FID 007; Nanoencapsulated Paclitaxel FID-007
Other: Pharmacokinetic Study
- Dose limiting toxicity (DLT) of PEOX-based polymer encapsulated paclitaxel FID-007 (FID-007) [ Time Frame: After first cycle (28 days) ]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.
- Incidence of adverse events [ Time Frame: Up to 2 years ]Will be reported using the CTCAE version 4.03.
- Clinical anti-tumor response (Complete Response [CR] and Partial Response [PR]) [ Time Frame: Up to 2 years ]Will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03537690
|Contact: Jessica Levano, RNemail@example.com|
|Contact: Lorraine Martinez, LVN||323-865-0967||Lorraine.martinez@Med.USC.Edu|
|United States, California|
|USC / Norris Comprehensive Cancer Center||Recruiting|
|Los Angeles, California, United States, 90033|
|Contact: Jessica Levano, RN 323-865-0593 firstname.lastname@example.org|
|Principal Investigator: Anthony El-Khoueiry, MD|
|Hoag Memorial Hospital||Recruiting|
|Newport Beach, California, United States, 92663|
|Contact: Alicia Bogardus, MA 949-764-6755 Alicia.email@example.com|
|Principal Investigator: Diana L. Hanna, MD|
|Principal Investigator:||Anthony El-Khoueiry, MD||University of Southern California|