Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Anti-tumor Activity of FN-1501 Monotherapy in Patients With Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT03690154|
Recruitment Status : Recruiting
First Posted : October 1, 2018
Last Update Posted : February 11, 2020
This research study is being done in people with advanced-stage solid tumor cancer. Advanced stage solid tumor cancer is a cancer that forms an abnormal mass of tissue that usually does not contain cysts or liquid areas. Different types of solid tumors are named for the type of cells that form them. Examples of solid tumors include lung cancer, breast cancer, prostate cancer, kidney cancer, colorectal cancer, melanoma and sarcoma.
The purpose of this research study is to evaluate the safety of the investigational study drug, FN-1501, at different dose levels. FN-1501 has not previously been given to human subjects. It is intended for the treatment in this study of patients with advanced solid tumor cancers. This study will determine the effects, good and/or bad, on patients' cancer. The main objective of this study is to define the recommended phase 2 dose (RP2D) and maximum tolerated dose (MTD) of FN-1501. The MTD is the highest dose a person can take without having bad side effects, and the RP2D will be the dose of FN-1501 used in future studies.
|Condition or disease||Intervention/treatment||Phase|
|Advanced Cancer Solid Tumor||Drug: FN-1501||Phase 1|
This is a phase 1, first-in-human, open-label, multicenter, dose escalation study.
Dose escalation will follow the traditional 3+3 design. Patients will be screened for eligibility for up to 28 days prior to entry into the study. The starting dose will be 2.5 mg/day (once daily). The period for DLT assessment is 21 days from the first dose of FN-1501. Evaluation of a cohort of at least three (3) patients completing DLT assessment at any given dose level is required prior to determining the next dose level and dose regimen for the subsequent cohort.
After the first patient in the cohort receives the Cycle 1, Day 1 dose, subsequent patients in that cohort will not be dosed until the first patient has been evaluated for at least 48 hours to exclude unexpected acute toxicity. The continuous safety evaluation will be performed by investigators, the medical monitor, and the sponsor. A Safety Monitoring Committee (SMC) will determine dose levels to be administered and dose regimen during dose escalation based on the data available from the previous dose levels. If an MTD is not identified due to paucity of DLTs, the RP2D will be determined based on pharmacokinetics, safety, tolerability, and preliminary efficacy.
If a patient wishes to continuously receive study treatment on completion of Cycle 1, the patient can continue study treatment in 21-day Cycle 2 and subsequent cycles (same as Cycle 2, all of 21 days' duration), defined as administration of 3 times per week for 2 weeks followed by one week off, at the discretion of the investigator.
The primary endpoint of this study is to determine the recommended phase 2 dose (RP2D) of FN-1501 based on pharmacokinetics, safety and tolerability, as well as preliminary efficacy.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1, Multi-center, Open-label, Single-arm, Dose-escalation, Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Anti-tumor Activity of FN-1501 Monotherapy in Patients With Advanced Solid Tumors or Relapsed/Refractory Acute Myeloid Leukemia (AML)|
|Actual Study Start Date :||July 23, 2018|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2020|
Eligible patients will receive a single intravenous infusion of study drug on Days 1, 3, 5, 8, 10, and 12 of a 21-day cycle. Dosing will begin at 2.5 mg once per day on the assigned days. Dose escalation will use the traditional 3+3 design and follow a modified Fibonacci sequence until MTD is reached. Increments of 33% in the dose of FN-1501 will be undertaken after reaching 30 mg/day. At least 3 patients will be enrolled in each cohort. Administration of FN-1501 will be continued until disease progression, intolerable toxicity, withdrawal of consent, or termination according to the Principal Investigator's judgment or at the sponsor's request.
- Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03 [ Time Frame: From first dose until 30 days after the last dose. ]
- To determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) [ Time Frame: During the first year. ]The recommended phase 2 dose (RP2D) of FN-1501 will be determined based on pharmacokinetics, safety and tolerability, as well as preliminary efficacy.
- Area under the plasma concentration-time curve from zero to the last measurable concentration (AUC0-last) [ Time Frame: During the first year. ]
- Area under concentration-time curve from 0 to 24 hours (AUC(0-24)) [ Time Frame: During the first year. ]
- Area under the plasma concentration time curve from zero to infinity (AUC0-∞) [ Time Frame: During the first year. ]
- Maximum observed plasma concentration (Cmax) [ Time Frame: During the first year. ]
- Time to maximum observed plasma concentration (tmax) [ Time Frame: During the first year. ]
- Terminal half-life (t1/2) [ Time Frame: During the first year. ]
- Clearance (CL) [ Time Frame: During the first year. ]
- Apparent volume of distribution (Vd) [ Time Frame: During the first year. ]
- Measurement of anti-tumor activity of FN-1501 according to RECIST version 1.1 (solid tumor) [ Time Frame: During the first year. ]
- Measurement of anti-tumor activity of FN-1501 including but not limited to CT/MRI images [ Time Frame: During the first year. ]
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): NCT03690154
|Contact: Te Lifirstname.lastname@example.org|
|United States, Kansas|
|KUMC Cancer Center||Recruiting|
|Fairway, Kansas, United States, 66205|
|Contact: Stephen K Williamson, MD 913-945-5059 email@example.com|
|Principal Investigator: Stephen K Williamson, MD|
|United States, Michigan|
|Karmanos Cancer Institute||Recruiting|
|Detroit, Michigan, United States, 48334|
|Contact: Ulka Vaishampayan, MD 248-538-4701 firstname.lastname@example.org|
|Principal Investigator: Ulka Vaishampayan, MD|
|Cabrini Malvern Hospital||Recruiting|
|Malvern, Victoria, Australia, 3144|
|Contact: Gary E Richardson, MD 1 300-300-977 email@example.com|
|Principal Investigator: Gary E Richardson, MD|