Study of FCN-011 in Patients With Advanced Solid Tumor（Phase I）and NTRK Fusion Positive Advanced … (NCT04687423) | Clinical Trial Compass
UnknownPhase 1
Study of FCN-011 in Patients With Advanced Solid Tumor（Phase I）and NTRK Fusion Positive Advanced Solid Tumor （Phase II）
China82 participantsStarted 2021-04-13
Plain-language 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)
Who can participate
Age range
16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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) ;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To determine the occurrence of treatment-related adverse events meeting the criteria for dose limiting toxicities (DLTs)
Timeframe: 30 days
2
The recommended phase II dose for FCN-011
Timeframe: From first dose up to 30 days after last dose
3
Overall response rate (ORR) by Response Criteria in Solid Tumors (RECIST) v1.1
. Can understand and be willing to sign informed consent prior to the commencement of any research procedure; Expected survival at least 12 weeks;
. 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;
Exclusion criteria
. 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;
. Cardiac function and disease meet one of the following conditions: