Advanced Solid TumorPhase 1NCT04687423
Study of FCN-011 in Patients With Advanced Solid Tumor（Phase I）and NTRK Fusion Positive Advanced Solid Tumor （Phase II）
A Phase 1 study testing FCN-011 in people with Advanced Solid Tumor, run by Fochon Pharmaceuticals, Ltd. at 1 site in China.
Trial summary
A multicenter, open, single-arm phase I dose exploration and phase II extended study was conducted to evaluate the safety, tolerability, pharmacokinetic characteristics, and primary antitumor activity of FCN-011 in patients with advanced solid tumor (phase I) and NTRK fusion positive advanced solid tumor (phase II) Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- FCN-011
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteChina
- Study dates
- 13 Apr 2021to 31 Mar 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥ 16 years，no gender limitation；
- Patients with inoperable solid tumors, stage III or IV, confirmed histologically or cytologically by standard treatment failure or no standard treatment;
- Sufficient tumor tissue samples from clinical phase I patients shall be sent to the central laboratory for NTRK fusion gene test, and the results of the central laboratory will not affect the inclusion of subjects (if multiple patients are screened, patients with positive NTRK fusion gene or point mutation will be preferred to be included);
- Sufficient tumor tissue samples must be provided for phase II clinical patients, which will be confirmed to be positive for NTRK fusion gene by the method of 2-generation gene sequencing by the central laboratory designated by the sponsor;
- The ECOG Scores 0 or 1 for physical fitness (phase I),0-2(phase II) ;
- Can understand and be willing to sign informed consent prior to the commencement of any research procedure; Expected survival at least 12 weeks;
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- Patients with adequate organ and bone marrow function: absolute value of neutrophils ≥ 1.0 × 10^9/L (no G-CSF treatment within 7 days);Hemoglobin ≥ 80g/L (no erythrocyte infusion within 7 days);Platelet ≥ 75 × 10^9/L; Serum total bilirubin ≤ 1.5 × upper limit normal (ULN), and patients with Gilbert syndrome ≤3.0 × ULN. Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 × ULN; For patients with liver metastasis, AST and ALT should be ≤ 5 × ULN. Creatinine<1.5×ULN or Creatinine clearance was ≥ 60 ml/min in phase I patients, and ≥ 45ml/min in phase II patients. Creatinine clearance was calculated by Cockroft - Gault formula. Albumin ≥ 3g/dL;
- At least one evaluable lesion (stage I) was assessed according to RECIST 1.1 or RANO criteria; According to RECIST 1.1 or RANO standard to evaluate, at least one measurable lesions (phase II) (primary central nervous system tumors according to the standard definition RANO, needs to have one or more measurable lesions by MRI assessment, size for at least 10 mm or more, and appeared in two or more ≤ 5 mm thick section, the measure does not include cystic cavity.) The imaging evaluation should be completed within 28 days before enrollment, and the patient's hormone dosage should be stable for at least 5 days or more;
- A fertile woman must have a negative serum pregnancy test within 28 days of the first study drug administration and agree to contraception between 28 days before the first study drug administration and 30 days after the last study drug administration; Male patients are required to undergo ligation or agree to contraception and refuse sperm donation from 7 days before the first dose to 30 days after the last dose; The failure rate of contraceptive methods<1% per year, such as double screen contraceptive methods, condoms, oral or injectable contraceptives.
Who cannot join
- Patients who received targeted therapy within 2 weeks or within 5 half-lives (whichever is shorter) before starting administration, and who received chemotherapy, major surgery, radiotherapy, immunotherapy or clinical trials within 4 weeks or within 5 half-lives (which is shorter);
- Uncontrolled or symptomatic brain metastases (asymptomatic or stably controlled CNS metastases and no hormone therapy within 2 weeks are allowed to be enrolled);Patients with spinal cord metastasis with symptoms of spinal cord compression;Primary CNS tumors were allowed to be enrolled.
- The toxicity of previous anti-tumor therapy has not recovered (>NCI-CITCAE 5.0 level 2), neurotoxic reaction level 2, except hair loss;
- Patients should use strong CYP3A4 inhibitors (except drugs permitted in Section 6.8), inducers or sensitive substrates and sensitive substrates of CYP2B6 at the same time;
- Patients take drugs (mainly Ia, Ic, class III anti-arrhythmia drugs) that will prolong the QTc interval or have risk factors for extending the QTc interval;
- Difficulty in swallowing, or having an absorbance syndrome, or other medical conditions that prevent the absorption of drugs through the intestinal tract, or affect the absorption of FCN-011;
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- Cardiac function and disease meet one of the following conditions:
- （1）screening period in research center 3 times of 12 lead ECG measurement, according to the instrument of QTc formula for calculating the average three times, QTc>470 ms;
- （2）continue uncontrolled hypertension, systolic blood pressure under antihypertensive treatment >150 mmHg, and/or diastolic pressure >100 mmHg；
- （3）the American New York Heart Association (New York Heart Association, NYHA) classification of grade 3 or more congestive Heart failure;
- （4）Arrhythmias of clinical significance, including but not limited to complete left bundle branch conduction anomaly, degree II atrioventricular block;
- （5）within 6 months prior to screening of a history of heart attack or a stroke within three months.
- 8. Phase I with active bacterial, fungal or viral infections of clinical significance, including hepatitis B (hepatitis B virus surface antigen-positive with HBV DNA exceeding 1000 IU/ml) or hepatitis C (HCV RNA positive), human immunodeficiency virus infection (HIV positive);Active bacterial, fungal or viral infections of clinical significance phase II, including patients with chronic hepatitis B with elevated aminotransferase or with evidence of cirrhosis (hepatitis B carriers allowed), positive hepatitis C virus (HCV) antibody test; Confirmed human immunodeficiency virus (HIV) infection and unwillingness to take HIV tests;
- 9. Has a past or present co-existing malignancies (other than non-melanoma skin basal cell carcinoma, breast/cervical carcinoma in situ, and other malignancies that have not been treated and that have been effectively controlled in the past five years) in addition to the indications;
- 10. Phase II should exclude patients who have previously used TRK gene targeted kinase inhibitor progression, including Entrectinib, Larotrectinib, etc. If the drug is discontinued due to an intolerant toxicity and the duration of treatment is less than 28 days, enrollment is allowed;
- 11. Patients with known drug-resistant mutations (including but not limited to NTRK1 G595R and NTRK3 G623R) were excluded in phase II;
- 12. Women who are pregnant or breastfeeding. Any patient who becomes pregnant during the trial should withdraw from the study;
- 13. Any other disease or condition of clinical significance (such as uncontrolled diabetes, active or uncontrolled infection, etc.) that the investigator considers may affect protocol compliance or affect the patient's signing of the ICF.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
Hu Xi chun, MD, 13816110335, xchu@2009hotmail.com
Hu Xi chun, MD
About this study
Official title: A Multicenter, Open, Single-arm Phase I Dose Exploration and Phase II Extended Study Was Conducted to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Primary Antitumor Activity of FCN-011 in Patients With Advanced Solid Tumor (Phase I) and NTRK Fusion Positive Advanced Solid Tumor (Phase II)
A multicenter, open, single-arm phase I dose exploration and phase II extended study was conducted to evaluate the safety, tolerability, pharmacokinetic characteristics, and primary antitumor activity of FCN-011 in patients with advanced solid tumor (phase I) and NTRK fusion positive advanced solid tumor (phase II)
Read the detailed description
This study is a multicenter, open, single-arm Phase I/II clinical study, which is divided into two research parts, namely phase I dose exploration study and phase II dose extension study. In the phase I dose exploration study, the safety, tolerance and PK characteristics of FCN-011 in patients with advanced solid tumors were determined, the MTD of oral fCN-011 was determined, and the RP2D of FCN-011 in the phase II clinical study was determined, and the efficacy of FCN-011 was preliminarily evaluated. The phase II dose extension study evaluated the efficacy, safety, and tolerability of continuous oral ADMINISTRATION of FCN-011 in patients with inoperable NTRK fusion and advanced stage III or IV solid tumors, as well as the characteristics of population pharmacokinetics (PopPK).
A total of 35-82 patients were enrolled in this study, 15-24 patients were expected to be enrolled in the phase I study, and 20-58 patients were expected to be enrolled in the phase II study.
- Conditions
- Advanced Solid Tumor
- Being tested
- FCN-011
- Keywords
- NTRK, FCN-011
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FCN-011Drug
FCN-011 will be given orally in ascending doses starting at 50 mg Q12h or 100mg QD until the maximum tolerated dose or recommended dose is reached.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: phase I dose exploration | Experimental | FCN-011 will be given orally in ascending doses in patients with advanced solid tumor , until the maximum tolerated dose or recommended dose is reached. Receives: Drug: FCN-011 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the occurrence of treatment-related adverse events meeting the criteria for dose limiting toxicities (DLTs)
Measured: 30 days
The recommended phase II dose for FCN-011
Measured: From first dose up to 30 days after last dose
Overall response rate (ORR) by Response Criteria in Solid Tumors (RECIST) v1.1
Measured: Baseline up to approximately 1 year
Secondary outcomes (7)
To quantify the occurrence of adverse events (AEs) reported in all subjects who received study drug
Measured: From enrollment up to 30 days after last dose
the death of the last medicine occurred within 30 days of frequency and cause of death
Measured: From enrollment up to 30 days after last dose
The occurrence of treatment-emergent adverse events (TEAs)
Measured: From enrollment up to 30 days after last dose
To quantify the last time point with a quantifiable concentration (AUClast) of FCN-011 after administration as a single agen
Measured: 2 months
To measure the time to reach the highest plasma concentrations (Tmax) of FCN-011 after single agent administration
Measured: 2 months
To quantify the terminal half-life (T1/2) of FCN-011 after administration as a single agent
Measured: 2 months
To quantify the dose-dependent serum concentrations (Cmax) of FCN-011 as a single agent
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start13 Apr 2021
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fochon Pharmaceuticals, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hu Xi chun, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04687423
- Sponsor's protocol ID
- FCN-011-001
- Status last verified
- Aug 2021
- First submitted
- 10 Dec 2020
- Last updated
- 18 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open, Single-arm Phase I Dose Exploration and Phase II Extended Study Was Conducted to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Primary Antitumor Activity of FCN-011 in Patients With Advanced Solid Tumor (Phase I) and NTRK Fusion Positive Advanced Solid Tumor (Phase II)
- ClinicalTrials.gov ID
- NCT04687423
- Acronym / sponsor ID
- FCN-011-001
- Conditions
- Advanced Solid Tumor
- Keywords
- NTRK, FCN-011
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Fochon Pharmaceuticals, Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Apr 2021 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 29 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multicenter, open, single-arm phase I dose exploration and phase II extended study was conducted to evaluate the safety, tolerability, pharmacokinetic characteristics, and primary antitumor activity of FCN-011 in patients with advanced solid tumor (phase I) and NTRK fusion positive advanced solid tumor (phase II)
Detailed description
This study is a multicenter, open, single-arm Phase I/II clinical study, which is divided into two research parts, namely phase I dose exploration study and phase II dose extension study. In the phase I dose exploration study, the safety, tolerance and PK characteristics of FCN-011 in patients with advanced solid tumors were determined, the MTD of oral fCN-011 was determined, and the RP2D of FCN-011 in the phase II clinical study was determined, and the efficacy of FCN-011 was preliminarily evaluated. The phase II dose extension study evaluated the efficacy, safety, and tolerability of continuous oral ADMINISTRATION of FCN-011 in patients with inoperable NTRK fusion and advanced stage III or IV solid tumors, as well as the characteristics of population pharmacokinetics (PopPK).
A total of 35-82 patients were enrolled in this study, 15-24 patients were expected to be enrolled in the phase I study, and 20-58 patients were expected to be enrolled in the phase II study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: phase I dose exploration | Experimental | Drug: FCN-011FCN-011 will be given orally in ascending doses in patients with advanced solid tumor , until the maximum tolerated dose or recommended dose is reached. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 16 years，no gender limitation；
- Patients with inoperable solid tumors, stage III or IV, confirmed histologically or cytologically by standard treatment failure or no standard treatment;
- Sufficient tumor tissue samples from clinical phase I patients shall be sent to the central laboratory for NTRK fusion gene test, and the results of the central laboratory will not affect the inclusion of subjects (if multiple patients are screened, patients with positive NTRK fusion gene or point mutation will be preferred to be included);
- Sufficient tumor tissue samples must be provided for phase II clinical patients, which will be confirmed to be positive for NTRK fusion gene by the method of 2-generation gene sequencing by the central laboratory designated by the sponsor;
- The ECOG Scores 0 or 1 for physical fitness (phase I),0-2(phase II) ;
Key exclusion criteria (18 listed)
- Patients who received targeted therapy within 2 weeks or within 5 half-lives (whichever is shorter) before starting administration, and who received chemotherapy, major surgery, radiotherapy, immunotherapy or clinical trials within 4 weeks or within 5 half-lives (which is shorter);
- Uncontrolled or symptomatic brain metastases (asymptomatic or stably controlled CNS metastases and no hormone therapy within 2 weeks are allowed to be enrolled);Patients with spinal cord metastasis with symptoms of spinal cord compression;Primary CNS tumors were allowed to be enrolled.
- The toxicity of previous anti-tumor therapy has not recovered (>NCI-CITCAE 5.0 level 2), neurotoxic reaction level 2, except hair loss;
- Patients should use strong CYP3A4 inhibitors (except drugs permitted in Section 6.8), inducers or sensitive substrates and sensitive substrates of CYP2B6 at the same time;
- Patients take drugs (mainly Ia, Ic, class III anti-arrhythmia drugs) that will prolong the QTc interval or have risk factors for extending the QTc interval;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FCN-011FCN-011 will be given orally in ascending doses starting at 50 mg Q12h or 100mg QD until the maximum tolerated dose or recommended dose is reached. | Drug | Experimental: phase I dose exploration |
Primary outcome
To determine the occurrence of treatment-related adverse events meeting the criteria for dose limiting toxicities (DLTs)
Time frame: 30 days
The recommended phase II dose for FCN-011
Time frame: From first dose up to 30 days after last dose
Overall response rate (ORR) by Response Criteria in Solid Tumors (RECIST) v1.1
Time frame: Baseline up to approximately 1 year
7 secondary outcomes
To quantify the occurrence of adverse events (AEs) reported in all subjects who received study drug
Time frame: From enrollment up to 30 days after last dose
the death of the last medicine occurred within 30 days of frequency and cause of death
Time frame: From enrollment up to 30 days after last dose
The occurrence of treatment-emergent adverse events (TEAs)
Time frame: From enrollment up to 30 days after last dose
To quantify the last time point with a quantifiable concentration (AUClast) of FCN-011 after administration as a single agen
Time frame: 2 months
To measure the time to reach the highest plasma concentrations (Tmax) of FCN-011 after single agent administration
Time frame: 2 months
To quantify the terminal half-life (T1/2) of FCN-011 after administration as a single agent
Time frame: 2 months
To quantify the dose-dependent serum concentrations (Cmax) of FCN-011 as a single agent
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hu Xi chun, MD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FCN-011 in people with Advanced Solid Tumor, run by Fochon Pharmaceuticals, Ltd. at 1 site in China.
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 9 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yang Huan (15882196553, hyang@fochon.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the occurrence of treatment-related adverse events meeting the criteria for dose limiting toxicities (DLTs) (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Aug 2021.