Solid Tumor, AdultPhase 1FCN-437cNCT03951116
Study of FCN-437c in Patients With Advanced Solid Tumors
A Phase 1 study testing FCN-437 in people with Solid Tumor, Adult, run by Fochon Pharmaceuticals, Ltd. at 3 sites in United States.
Trial summary
This research study is studying a drug called FCN-437c as a possible treatment for patients with advanced unresectable/metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult
- What is being tested?
- FCN-437
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 3 sitesUnited States
- Study dates
- 25 Jun 2019to 8 Dec 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have given written informed consent prior to any study specific procedures
- Male or female subject ≥ 18 years
- Histologically/cytologically confirmed, unresectable locally advanced or metastatic solid tumors that are refractory to standard therapy or for which no standard therapy exists. Note for patients with non-small cell lung cancer [NSCLC] and patients with activating ALK translocation, or EFGR mutations must have been treated and failed appropriate targeted treatment).
- Subjects enrolled in cohort expansion at MTD should have specific tumor types as below:
- KRAS mutant NSCLC confirmed by a documented historical report
- Breast cancer previously treated with a CDK4/6 inhibitor
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- All subjects should have evaluable disease as per RECIST 1.1 (Eisenhauer, 2009).
- Subjects enrolled in cohort expansion at MTD should have measurable disease (presence of at least one measurable lesion) as per RECIST 1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 1
- Subjects with life expectancy of ≥ 3 months
- Subjects with central nervous system (CNS) metatases are eligible if clinically controlled that is defined as surgical excision/and or radiation therapy followed by 3 weeks of stable neurologic function and no evidence of CNS disease progression as determined by contrast-enhanced computer tomography (CT) and nuclear magnetic resonance imaging (MRI) within 3 weeks prior to the first dose of study drug.
- Must have adequate organ function, including the following:
- Bone marrow reserve: absolute neutrophil count (ANC) ≥ 1.5 X 10 9/L; platelet count ≥ 100 x 10 9/L;hemoglobin ≥ 9g/dL or ≥ 5.6 mmol/L
- Hepatic: total bilirubin ≤ 1.5 times the upper limit of normal (ULN), aspartate transaminase (AST) and/or alanine aminotransferase (ALT) ≤ 2.5 times ULN (< 5 times ULN if liver metastases).
- Renal: estimated creatinine clearance ≥ 45 mL/min based on the Cockcroft-Gault equation (Appendix 19.4).
- Coagulation: INR < 2.0, activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN.
- Subjects are able to swallow capsules.
- Subjects (women of child-bearing potential and males) should be willing to use viable contraception method that is deemed effective by the Investigator throughout the treatment period and for at least 3 months following the last dose of study drug. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential.
Who cannot join
- Females during pregnancy or breastfeeding.
- Subjects on any anticancer therapy approved or experimental, including chemotherapy, immune therapy, radiation therapy, hormonal therapy (Exceptions: hormone-replacement therapy, testosterone or oral contraceptives), biologic therapy, within 3 weeks (or 5 half-lives whichever is shorter) prior to initiation of study treatment. Note: Subjects should be recovered from treatment related toxicity resolved to baseline except for residual alopecia.
- Subjects who had prior treatment with a CDK4/6 inhibitor except Hormone receptor (HR)+/Human epidermal growth factor receptor 2 (HER2)- breast cancer patients who may have received CDK4/6 inhibitor as a standard treatment.
- Subjects with history of gastric bypass surgery or banding procedure.
- Subjects who have had major surgery within the 28-days from the screening or subjects who have undergone organ transplant surgery.
- Active hepatitis B (HBV) or hepatitis C (HCV). HBV carriers without active disease (HBV DNA titer < 1000 cps/mL or 200 IU/mL), or cured HCV (negative HCV RNA test) may be enrolled. Subjects with controlled human immunodeficiency virus (HIV) disease may be eligible.
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- Subjects with a concomitant medical condition that would increase the risk of toxicity, in the opinion of the Investigator or Sponsor.
- Unresolved toxicities (other than alopecia) from previous anti-cancer therapy defined as toxicities not resolved to NCI CTCAE Version 5.0, Grade ≤ 1.
- Subject who have had severe infection within 4 weeks or signs and symptoms of any active infection within 2 weeks prior to the first dose administration.
- Severe or uncontrolled cardiac disease requiring treatment, congestive heart failure New York Heart Association (NYHA) III or IV, unstable angina pectoris even if medically controlled, history of myocardial infarction during the last 3 months, serious arrhythmias requiring medication (with exception of atrial fibrillation or paroxysmal supraventricular tachycardia).
- A resting ECG with QTcF ≥ 470 msc or the subject has a congenital prolonged QT syndrome or with concomitant medications known to prolong the QT interval.
- Taking a prohibited concomitant medication or inability to follow concomitant medications guidelines
- Any other serious underlying medical (e.g., uncontrolled diabetes mellitus, uncontrolled hypertension, active uncontrolled infection, active gastric ulcer, uncontrolled seizures, severe hearing impairment, cerebrovascular incidents, gastrointestinal bleeding, severe signs and symptoms of coagulation and clotting disorders, cardiac conditions), psychiatric, psychological, familial or geographical condition that, in the judgment of the Investigator, may interfere with the planned staging, treatment and follow-up, affect subject compliance or place the subject at high risk from treatment-related complications.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
City of Hope National Medical Center
Duarte, California, 91010
Sarah Cannon Research Institute at Tennessee Oncology
Nashville, Tennessee, 37203
South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas, 78229
About this study
Official title: Phase 1 Study of FCN-437c in Patients With Advanced Solid Tumors
This research study is studying a drug called FCN-437c as a possible treatment for patients with advanced unresectable/metastatic solid tumors.
Read the detailed description
This research study is a Phase I clinical trial, which tests the safety of an investigational intervention and also tries to define the appropriate dose of the investigational intervention to use for further studies. "Investigational" means that the intervention is being studied.
In this research study, the investigators are evaluating a new drug, FCN-437c, as a potential new treatment for cancer.
The FDA (the U.S. Food and Drug Administration) has not approved FCN-437c as a treatment for any disease.
FCN-437c is a new generation CDK4/6 inhibitor. The CDK 4/6 inhibitors play a key role in regulating the transition from G1 to the S-phase of the cell cycle.
The cyclin D-cyclin dependent kinase (CDK) 4/6-inhibitor of CDK4 (INK4)-retinoblastoma (Rb) pathway controls cell cycle progression by regulating the G1-S checkpoint. Dysregulation of the cyclin D-CDK4/6-INK4-Rb pathway results in increased proliferation, and is frequently observed in many types of cancer. Due to the importance of CDK4/6 activity in cancer cells, CDK4/6 inhibitors have emerged as promising candidates for cancer treatment.
FCN-437c is a novel, potent and selective inhibitor of CDK4/6 exhibiting cellular potency against a number of human tumor cell lines.
Laboratory experiments show that FNC-437c may stop tumor growth.
The purposes of this study are:
- To evaluate the safety and tolerability of FCN-437c when administered orally to subjects with advanced solid tumors
- To determine the MTD and/or the Phase 2 Dose for FCN-437c
- Conditions
- Solid Tumor, Adult
- Being tested
- FCN-437
- Keywords
- solid tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FCN-437Drug
FCN-437c is a selective and potent CDK4/6 dual inhibitor, with broad antitumor activity in preclinical pharmacology models, favorable physical and pharmacokinetic (PK) properties, and acceptable toxicity profile in nonclinical studies.
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation cohort of FCN-437c | Experimental | The dose-escalation cohort:
* Participants will receive FCN-437c monotherapy once daily (QD) for 21 days followed by a 7 day rest period (28-day cycle).
* FCN-437c will be administered orally.
* Participants with histologically or cytologically confirmed advanced unresectable/metastatic solid tumor will participate in this cohort. Receives: Drug: FCN-437 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To quantify the occurrence of adverse events (AEs) reported in all subjects who received study drug
Incidence of untoward medical occurrences (adverse event = AE) in a participant who received study drug. Adverse events will be evaluated by dosing cohort and recorded according to NCI CTCAEv5 Common Toxicity Criteria.
Measured: From enrollment up to 30 days after last dose
To determine the occurrence of treatment-emergent adverse events (TEAs)
Incidence of untoward medical occurrences (adverse event = AE) attributed to study drug in a participant who received study drug. Adverse events will be evaluated and recorded by dosing cohort according to NCI CTCAEv5 Common Toxicity Criteria.
Measured: From first dose up to 30 days after last dose
To determine the occurrence of treatment-related adverse events meeting the criteria for dose limiting toxicities (DLTs)
Incidence of the DLT population will consist all subjects who received the required amount of study drug during the DLT observation period of 28 days (21 days of daily dosing, 7 days of no dosing) of study treatment . Treatment-related AE is any untoward medical occurrence attributed to study drug in a participant that who received study drug. Treatment-related AE is any untoward medical occurrence attributed to study drug in a participant who received study drug. DLTs are adverse events meeting the protocol-specified criteria, evaluated and recorded according to NCI CTCAEv5 Common Toxicity Criteria will use medical terminology based on the Medical Dictionary for Regulatory Activities Terminology (MedDRA).
Measured: From first dose up to 28 days
Secondary outcomes (9)
To quantify the area under the serum concentration versus time curve (AUC) of FCN-437c after administration as a single agent
Quantify the dose-dependent area under the serum concentration versus time curve (AUC) for FCN-437c following single dosing FCN-437c
Measured: 2 months
To quantify the last time point with a quantifiable concentration (AUClast) of FCN-437c after administration as a single agent
Determine the dose-dependent plasma concentrations of FCN-437c from the time of dosing to the last time point with a quantifiable concentration (AUClast) of FCN-437-c following single doses of FCN-437c as a single agent.
Measured: 2 months
To quantify the plasma concentrations at the end of a dosing interval (Ctau) of FCN-437c after administration as a single agent
Determine the dose-dependent serum concentrations (Cmax) of FCN-437c as as a single agent at the end of a dosing interval (Ctau), where tau is 24 hours
Measured: 2 months
To quantify the lowest plasma concentration at the end of a dosing interval (Ctrough)
Determine the dose-dependent lowest plasma concentrations (Ctrough) of FCN-437c as a single agent at the end of a dosing interval
Measured: 2 months
To measure the time to reach the highest plasma concentrations (Tmax) of FCN-437c after single agent administration
Determine the dose-dependent time (Tmax) to reach the highest plasma concentrations of FCN-437c by direct inspection of the plasma concentration time curves of FCN-437c following single agent doses of FCN-437c
Measured: 2 months
To quantify the terminal half-life (T1/2) of FCN-437c after administration as a single agent
Determine the dose-dependent terminal plasma half-life of FCN-437 (T 1/2) as single agent
Measured: 2 months
To quantify the plasma clearance (CL/f) of FCN-437c after administration as a single agent
Determine the dose-dependent apparent total plasma clearance (CL/f) of FCN-437c after administration as a single agent
Measured: 2 months
To evaluate the volume of distribution (Vf) of FCN-437c after administration as a single agent
Determine the apparent steady-state volume of distribution (Vf) during terminal phase after administration of FCN-437c as single agent
Measured: 2 months
To determine the best overall response rate (ORR) by Response Criteria in Solid Tumors (RECIST) v1.1 in subjects with advanced solid tumors
To evaluate the proportion of patients with an objective response (SD, PR, CR) as defined by RECIST 1.1.
Measured: Baseline up to approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start25 Jun 2019
- Primary completion8 Dec 2021
- Study completion8 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies 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
- Model description
- Open-Label Phase 1 Dose escalation study
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fochon Pharmaceuticals, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amita Patmaik, MD, Principal investigator, South Texas Accelerated Research Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03951116
- Sponsor's protocol ID
- FCN-437c-001
- Acronym
- FCN-437c
- Status last verified
- Mar 2022
- First submitted
- 9 May 2019
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of FCN-437c in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT03951116
- Acronym / sponsor ID
- FCN-437c / FCN-437c-001
- Conditions
- Solid Tumor, Adult
- Keywords
- solid tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Fochon Pharmaceuticals, Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Jun 2019 (actual)
- Primary completion
- 8 Dec 2021 (actual)
- Study completion
- 8 Dec 2021 (actual)
- First posted
- 15 May 2019 (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.
This research study is studying a drug called FCN-437c as a possible treatment for patients with advanced unresectable/metastatic solid tumors.
Detailed description
This research study is a Phase I clinical trial, which tests the safety of an investigational intervention and also tries to define the appropriate dose of the investigational intervention to use for further studies. "Investigational" means that the intervention is being studied.
In this research study, the investigators are evaluating a new drug, FCN-437c, as a potential new treatment for cancer.
The FDA (the U.S. Food and Drug Administration) has not approved FCN-437c as a treatment for any disease.
FCN-437c is a new generation CDK4/6 inhibitor. The CDK 4/6 inhibitors play a key role in regulating the transition from G1 to the S-phase of the cell cycle.
The cyclin D-cyclin dependent kinase (CDK) 4/6-inhibitor of CDK4 (INK4)-retinoblastoma (Rb) pathway controls cell cycle progression by regulating the G1-S checkpoint. Dysregulation of the cyclin D-CDK4/6-INK4-Rb pathway results in increased proliferation, and is frequently observed in many types of cancer. Due to the importance of CDK4/6 activity in cancer cells, CDK4/6 inhibitors have emerged as promising candidates for cancer treatment.
FCN-437c is a novel, potent and selective inhibitor of CDK4/6 exhibiting cellular potency against a number of human tumor cell lines.
Laboratory experiments show that FNC-437c may stop tumor growth.
The purposes of this study are:
- To evaluate the safety and tolerability of FCN-437c when administered orally to subjects with advanced solid tumors
- To determine the MTD and/or the Phase 2 Dose for FCN-437c
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-Label Phase 1 Dose escalation study
| Arm | Type | Receives |
|---|---|---|
| Dose escalation cohort of FCN-437c | Experimental | Drug: FCN-437The dose-escalation cohort: * Participants will receive FCN-437c monotherapy once daily (QD) for 21 days followed by a 7 day rest period (28-day cycle). * FCN-437c will be administered orally. * Participants with histologically or cytologically confirmed advanced unresectable/metastatic solid tumor will participate in this cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Have given written informed consent prior to any study specific procedures
- Male or female subject ≥ 18 years
- Histologically/cytologically confirmed, unresectable locally advanced or metastatic solid tumors that are refractory to standard therapy or for which no standard therapy exists. Note for patients with non-small cell lung cancer [NSCLC] and patients with activating ALK translocation, or EFGR mutations must have been treated and failed appropriate targeted treatment).
- All subjects should have evaluable disease as per RECIST 1.1 (Eisenhauer, 2009).
- Subjects enrolled in cohort expansion at MTD should have measurable disease (presence of at least one measurable lesion) as per RECIST 1.1.
Key exclusion criteria (13 listed)
- Females during pregnancy or breastfeeding.
- Subjects on any anticancer therapy approved or experimental, including chemotherapy, immune therapy, radiation therapy, hormonal therapy (Exceptions: hormone-replacement therapy, testosterone or oral contraceptives), biologic therapy, within 3 weeks (or 5 half-lives whichever is shorter) prior to initiation of study treatment. Note: Subjects should be recovered from treatment related toxicity resolved to baseline except for residual alopecia.
- Subjects who had prior treatment with a CDK4/6 inhibitor except Hormone receptor (HR)+/Human epidermal growth factor receptor 2 (HER2)- breast cancer patients who may have received CDK4/6 inhibitor as a standard treatment.
- Subjects with history of gastric bypass surgery or banding procedure.
- Subjects who have had major surgery within the 28-days from the screening or subjects who have undergone organ transplant surgery.
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-437FCN-437c is a selective and potent CDK4/6 dual inhibitor, with broad antitumor activity in preclinical pharmacology models, favorable physical and pharmacokinetic (PK) properties, and acceptable toxicity profile in nonclinical studies. | Drug | Dose escalation cohort of FCN-437c |
Primary outcome
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
Incidence of untoward medical occurrences (adverse event = AE) in a participant who received study drug. Adverse events will be evaluated by dosing cohort and recorded according to NCI CTCAEv5 Common Toxicity Criteria.
To determine the occurrence of treatment-emergent adverse events (TEAs)
Time frame: From first dose up to 30 days after last dose
Incidence of untoward medical occurrences (adverse event = AE) attributed to study drug in a participant who received study drug. Adverse events will be evaluated and recorded by dosing cohort according to NCI CTCAEv5 Common Toxicity Criteria.
To determine the occurrence of treatment-related adverse events meeting the criteria for dose limiting toxicities (DLTs)
Time frame: From first dose up to 28 days
Incidence of the DLT population will consist all subjects who received the required amount of study drug during the DLT observation period of 28 days (21 days of daily dosing, 7 days of no dosing) of study treatment . Treatment-related AE is any untoward medical occurrence attributed to study drug in a participant that who received study drug. Treatment-related AE is any untoward medical occurrence attributed to study drug in a participant who received study drug. DLTs are adverse events meeting the protocol-specified criteria, evaluated and recorded according to NCI CTCAEv5 Common Toxicity Criteria will use medical terminology based on the Medical Dictionary for Regulatory Activities Terminology (MedDRA).
9 secondary outcomes
To quantify the area under the serum concentration versus time curve (AUC) of FCN-437c after administration as a single agent
Time frame: 2 months
To quantify the last time point with a quantifiable concentration (AUClast) of FCN-437c after administration as a single agent
Time frame: 2 months
To quantify the plasma concentrations at the end of a dosing interval (Ctau) of FCN-437c after administration as a single agent
Time frame: 2 months
To quantify the lowest plasma concentration at the end of a dosing interval (Ctrough)
Time frame: 2 months
To measure the time to reach the highest plasma concentrations (Tmax) of FCN-437c after single agent administration
Time frame: 2 months
To quantify the terminal half-life (T1/2) of FCN-437c after administration as a single agent
Time frame: 2 months
To quantify the plasma clearance (CL/f) of FCN-437c after administration as a single agent
Time frame: 2 months
To evaluate the volume of distribution (Vf) of FCN-437c after administration as a single agent
Time frame: 2 months
To determine the best overall response rate (ORR) by Response Criteria in Solid Tumors (RECIST) v1.1 in subjects with advanced solid tumors
Time frame: Baseline up to approximately 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
- Individual participant dataSharing planned: No
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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.
Amita Patmaik, MD principal investigator
South Texas Accelerated Research Therapeutics
3 sites 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-437 in people with Solid Tumor, Adult, run by Fochon Pharmaceuticals, Ltd. 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 18 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: finished, as of the sponsor's last update on 16 Mar 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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 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 16 Mar 2022.