Breast NeoplasmsPhase 1/2NCT04488107
Safety, Tolerability, Pharmacokinetics and Antitumor Activity of FCN-437c
A Phase 1/2 study testing FCN-437c and Letrozole 2.5mg in people with Breast Neoplasms, run by Ahon Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a multicenter, open, single arm dose escalation and dose expansion clinical study to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of FCN-437c alone or in combination with letrozole in women with ER +/ HER2 - advanced breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- FCN-437c and Letrozole 2.5mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- 14 Feb 2019to 30 Jun 2022
- Phase
- Phase 1/2
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (>= 18 years old) patients diagnosed as ER +/ HER2 - advanced breast cancer, without standard treatment or unable to receive standard treatment;
- The eastern cooperative oncology group (ECOG) score is 0 or 1;
- According to RECIST version 1.1, there was at least one measurable lesion or only bone metastasis;
- The expected survival period is at least 12 weeks;
- Patients have sufficient bone marrow and organ function;
- Patients is willing and able to follow the planned visit, treatment plan, laboratory examination and other test procedures;
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- Patients fully understand the study and are willing to sign the informed consent form (ICF);
- The inclusion criteria specific for the dose expansion stage are as follows.
- The postmenopausal patients (>= 18 years old) diagnosed as ER +/ HER2 - breast cancer have evidence of local recurrence or metastasis, and are not suitable for surgical resection or radiotherapy for the purpose of cure;
- There was neither history of systematic treatment nor clinical indication for chemotherapy for patients in the dose expansion stage;
- The patients in the dose expansion stage should neither have received neoadjuvant or adjuvant endocrine therapy previously, nor have progression free survival during or after the neoadjuvant or adjuvant endocrine therapy was shorter than 12 months.
Who cannot join
- HER2 + breast cancer, either defined as by fluorescence hybridization (FISH) or detected by standard immunohistochemistry (IHC);
- History of previous CDK4 / 6 inhibitors treatment;
- Received anti-tumor chemotherapy, major surgery, radiotherapy, biological drug therapy or other research drug treatment within 28 days before enrollment;
- The toxicity of previous anti-tumor therapy has not recovered (>= grade 2 according to NCI CTCAE version 5.0), except for hair loss; the neurotoxicity of patients who have received chemotherapy before should be restored to grade 2 or below based on NCI CTCAE version 5.0;
- The patient used CYP3A strong inhibitor or CYP3A inducer 14 days before the first dose administration;
- Cardiac dysfunction or disease are consistent with one of the following conditions such as arrhythmia with clinical significance, any risk factors increasing risk of QTc interval prolongation, or congestive heart failure (CHF) with grade ≥ 3 according to NYHA ;
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- Dysphagia, active digestive system disease, major gastrointestinal surgery, malabsorption syndrome, or other conditions that may impair the absorption of FCN-437c;
- Known allergy to letrozole, FNC-437c or any other excipients;
- Uncontrolled central system metastasis;
- Active infection, including HBV, HCV, HIV, et al;
- Any other disease or condition of clinical significance (e.g., uncontrolled diabetes, active or uncontrollable infection) that the researchers believe may affect protocol compliance or affect patients' signing of ICF;
- The exclusion criteria specific for the dose expansion stage was as follows.
- Postmenopausal women with advanced breast cancer who have received neoadjuvant / adjuvant endocrine therapy and progressed less than 12 months after treatment;
- Patients with advanced breast cancer who had received systemic anti-tumor therapy including endocrine and chemotherapy (patients with ER + and HER2 - who had received aromatase inhibitors for no more than 14 days were allowed to be enrolled) ;
- Other exclusion criteria are the same as those of the dose escalation stage.
Trial locations and contacts
1 site in 1 country.
Jian Zhang, M.D. contact
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai
Xichun Hu, M.D., 13816110335, xchu2009@hotmail.com
Jian zhang, M.D., syner2000@163.com
About this study
Official title: A Multicenter, Open, Single Arm Dose-escalation and Dose-expansion Study: to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of FCN-437c Alone or in Combination With Letrozole in ER+/ HER2- Advanced Breast Cancer
This is a multicenter, open, single arm dose escalation and dose expansion clinical study to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of FCN-437c alone or in combination with letrozole in women with ER +/ HER2 - advanced breast cancer.
Read the detailed description
This is a multicenter, open, single arm clinical study to evaluate the safety, tolerability, and antitumor activity of FCN-437c in combination with letrozole in postmenopausal women with ER + / HER2 - advanced breast cancer, and to evaluate the PK characteristics of FCN-437c monotherapy and combined therapy.
The single drug administration period (7 days) . The continuous administration period made up of 21 days of continuous administration, followed by 7 days of withdrawal, which made up of 28 days as a treatment cycle. The evaluation was conducted every 8 weeks until one of the following happened, disease progression, intolerable toxicity, death, the researcher's decision or the patients' voluntary withdrawal from the study. The follow-up visit was conducted 30 days after the last administration. The telephone follow-up was conducted once every 3 months until the end of the study to record the survival period.
In the expansion period, FCN-437c was continuous administration per day for 21 days, followed by 7 days of withdrawal, making a treatment cycle of 28 days during which letrozole was continuously administrated 2.5 mg QD. Evaluation was conducted every 8 weeks until one of the following occurred, disease progression, intolerable toxicity, death, decision of the researcher or patients' voluntary withdrawal of the study. Follow up visit was conducted 30 days after the last administration, followed by the survival period telephone follow-up every 3 months until the end of the study.
End of of the study was defined as the last patient in the dose expansion stage took the treatment for more than one year, or terminated the treatment (depending on which occurred earlier.
At the end of the study, patients with no disease progression were determined to continue taking FCN-437c according to the clinical benefits.
- Conditions
- Breast Neoplasms
- Being tested
- FCN-437c, Letrozole 2.5mg
- Keywords
- ER-Positive, HER2-Negative, Breast Neoplasms
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FCN-437cDrug
Also called Dose-escalation and expansion
- 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.
Letrozole 2.5mgDrug
Also called Dose-escalation
- Letrozole is the latest generation of aromatase inhibitor. Letrozole lowers estrogen levels in postmenopausal women, which may slow the growth of certain types of breast tumors that need estrogen to grow in the body.
- Letrozole is used to treat breast cancer in postmenopausal women. It is often given to women who have been taking tamoxifen (Nolvadex, Soltamox) for 5 years.
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation cohort of FCN-437c | Experimental | * This study plans to start escalating from 50 mg QD, through 100 mg, 200 mg, 300 mg, 450 mg, to 600 mg.
* Participants will receive FCN-437c in sequential 28-day cycles which are made up of monotherapy QD for 21 days followed by a 7 day rest period.
* Participants must be histologically or cytologically diagnosed with ER+/ HER2- advanced breast cancer. Receives: Drug: FCN-437c |
| Dose expansion cohort of FCN-437c + letrozole | Experimental | * The dose expansion stage will be initiated after escalating to MTD.
* Six patients will be treated with FCN-437c combined with letrozole.
* DLT assessment and PK blood collection will be completed in the first 28-day cycle.
* If DLT does not occur in the first three patients, 15 additional patients were enrolled to complete the expansion study of MTD group.
* If one DLT occurs in the first three patients, three additional patients will be enrolled onal patients were enrolled and completed the MTD group.
* Patients will be evaluated every 8 weeks until disease progression, intolerable toxicity, death, investigator's decision or patient's voluntary withdrawal from the study. Receives: Drug: FCN-437c; Drug: Letrozole 2.5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT within 7 days of FCN-437c monotherapy
The incidence of DLT occurred within 7 days of FCN-437c monotherapy
Measured: 7 days
DLT within 28 days of FCN-437c monotherapy
The incidence of DLT occurred within 28 days of FCN-437c monotherapy
Measured: 28 days
DLT within 28 days of FCN-437c combined therapy
The incidence of DLT occurred within 28 days of the letrozole-combined treatment.
Measured: 28 days
Adverse events until the last followup
The types and frequencies of adverse events (AEs) evaluated according to the National Cancer Institute Common Terminology Criteria for adverse events (NCI-CTCAE) version 5.0.
Measured: through study completion, assessed up to 24 months
Serious and significant adverse events
Serious adverse events (SAE) and toxic reactions leading to permanent drug withdrawal occurred during the treatment.
Measured: through study completion, assessed up to 24 months
Incidence of Deaths
The frequency and causes of deaths during the treatment.
Measured: through study completion, assessed up to 24 months
Incidence of abnormal laboratory results
Abnormal laboratory results of safety concerns such as ALT, AST, Cr and BUN, et al according to NCI-CTCAE 5.0 classification.
Measured: through study completion, assessed up to 24 months
Changes of ECGs from baselines
Changes of ECGs from baselines, such as QT interval。
Measured: through study completion, assessed up to 24 months
Secondary outcomes (11)
Anti-tumor efficacy of monotherapy
Objective response rate (ORR) of FCN-437c monotherapy.
Measured: through study completion, assessed up to 24 months
Anti-tumor efficacy of combined treatment
Objective response rate (ORR) of FCN-437c and letrozole-combined treatment.
Measured: through study completion, assessed up to 24 months
FPS
Progression free survival (PFS) during the treatment.
Measured: through study completion, assessed up to 24 months
OS
overall survival (OS) during the treatment.
Measured: through study completion, assessed up to 24 months
survival rate
1-year OS rate during the 1st year of treatment.
Measured: through study completion, assessed up to 24 months
DOR
duration of response (DOR) during the treatment.
Measured: through study completion, assessed up to 24 months
CBR
clinical benefit response (CBR) during the treatment.
Measured: through study completion, assessed up to 24 months
Cmax of FCN-437c in monotherapy
Maximal plasma concentration of FCN-437c in monotherapy.
Measured: through study completion, assessed up to 24 months
AUC of FCN-437c in monotherapy
Entire exposure of FCN-437c in monotherapy.
Measured: through study completion, assessed up to 24 months
Cmax of FCN-437c in combined treatment
Maximal plasma concentration of FCN-437c combined with letrozole.
Measured: through study completion, assessed up to 24 months
AUC of FCN-437c in combined treatment
Entire exposure of FCN-437c combined with letrozole.
Measured: through study completion, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start14 Feb 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This study plans to start dose escalating from 50 mg, followed by 100, 200, 300, 450, and 600 mg as tentatively designated escalating dose groups. After the initial dose group, it is allowed to adjust the subsequent dose level according to the test data, but it will not exceed 100% dose increment. After the completion of DLT observation in each group, the next dose group and the number of cases were determined according to the safety, efficacy and PK data of the dose group. The traditional "3+3" method was used in the design of dose escalating stage, and the improved Fibonacci series was used for the dose increasing stage.
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahon Pharmaceutical Co., Ltd.
- Sponsor type
- University, hospital or other
- Collaborators
- Fudan University, Zhejiang Cancer Hospital, Sir Run Run Shaw Hospital
- Responsible party
- Sponsor
- Investigators
- Xichun Hu, M.D., Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04488107
- Sponsor's protocol ID
- AH150201
- Status last verified
- Jul 2020
- First submitted
- 13 Jul 2020
- Last updated
- 27 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Curigliano G, Gomez Pardo P, Meric-Bernstam F, Conte P, Lolkema MP, Beck JT, Bardia A, Martinez Garcia M, Penault-Llorca F, Dhuria S, Tang Z, Solovieff N, Miller M, Di Tomaso E, Hurvitz SA. Ribociclib plus letrozole in early breast cancer: A presurgical, window-of-opportunity study. Breast. 2016 Aug;28:191-8. doi: 10.1016/j.breast.2016.06.008. Epub 2016 Jun 20.
PubMed 27336726Infante JR, Cassier PA, Gerecitano JF, Witteveen PO, Chugh R, Ribrag V, Chakraborty A, Matano A, Dobson JR, Crystal AS, Parasuraman S, Shapiro GI. A Phase I Study of the Cyclin-Dependent Kinase 4/6 Inhibitor Ribociclib (LEE011) in Patients with Advanced Solid Tumors and Lymphomas. Clin Cancer Res. 2016 Dec 1;22(23):5696-5705. doi: 10.1158/1078-0432.CCR-16-1248. Epub 2016 Aug 19.
PubMed 27542767Tamura K, Mukai H, Naito Y, Yonemori K, Kodaira M, Tanabe Y, Yamamoto N, Osera S, Sasaki M, Mori Y, Hashigaki S, Nagasawa T, Umeyama Y, Yoshino T. Phase I study of palbociclib, a cyclin-dependent kinase 4/6 inhibitor, in Japanese patients. Cancer Sci. 2016 Jun;107(6):755-63. doi: 10.1111/cas.12932. Epub 2016 May 11.
PubMed 26991823Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.
PubMed 19097774Elsasser A, Regnstrom J, Vetter T, Koenig F, Hemmings RJ, Greco M, Papaluca-Amati M, Posch M. Adaptive clinical trial designs for European marketing authorization: a survey of scientific advice letters from the European Medicines Agency. Trials. 2014 Oct 2;15:383. doi: 10.1186/1745-6215-15-383.
PubMed 25278265Zhang J, Wang X, Wang X, Hui A, Wu Z, Tian L, Xu C, Yang Y, Zhang W, Hu X. Phase 1a study of the CDK4/6 inhibitor, FCN-437c, in Chinese patients with HR + /HER2- advanced breast cancer. Invest New Drugs. 2021 Dec;39(6):1549-1558. doi: 10.1007/s10637-021-01133-2. Epub 2021 Jun 9.
PubMed 34109484
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open, Single Arm Dose-escalation and Dose-expansion Study: to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of FCN-437c Alone or in Combination With Letrozole in ER+/ HER2- Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT04488107
- Acronym / sponsor ID
- AH150201
- Conditions
- Breast Neoplasms
- Keywords
- ER-Positive, HER2-Negative, Breast Neoplasms
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Ahon Pharmaceutical Co., Ltd.University, hospital or other
- Collaborators
- Fudan University, Zhejiang Cancer Hospital, Sir Run Run Shaw Hospital
- Study start
- 14 Feb 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 27 Jul 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.
This is a multicenter, open, single arm dose escalation and dose expansion clinical study to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of FCN-437c alone or in combination with letrozole in women with ER +/ HER2 - advanced breast cancer.
Detailed description
This is a multicenter, open, single arm clinical study to evaluate the safety, tolerability, and antitumor activity of FCN-437c in combination with letrozole in postmenopausal women with ER + / HER2 - advanced breast cancer, and to evaluate the PK characteristics of FCN-437c monotherapy and combined therapy.
The single drug administration period (7 days) . The continuous administration period made up of 21 days of continuous administration, followed by 7 days of withdrawal, which made up of 28 days as a treatment cycle. The evaluation was conducted every 8 weeks until one of the following happened, disease progression, intolerable toxicity, death, the researcher's decision or the patients' voluntary withdrawal from the study. The follow-up visit was conducted 30 days after the last administration. The telephone follow-up was conducted once every 3 months until the end of the study to record the survival period.
In the expansion period, FCN-437c was continuous administration per day for 21 days, followed by 7 days of withdrawal, making a treatment cycle of 28 days during which letrozole was continuously administrated 2.5 mg QD. Evaluation was conducted every 8 weeks until one of the following occurred, disease progression, intolerable toxicity, death, decision of the researcher or patients' voluntary withdrawal of the study. Follow up visit was conducted 30 days after the last administration, followed by the survival period telephone follow-up every 3 months until the end of the study.
End of of the study was defined as the last patient in the dose expansion stage took the treatment for more than one year, or terminated the treatment (depending on which occurred earlier.
At the end of the study, patients with no disease progression were determined to continue taking FCN-437c according to the clinical benefits.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study plans to start dose escalating from 50 mg, followed by 100, 200, 300, 450, and 600 mg as tentatively designated escalating dose groups. After the initial dose group, it is allowed to adjust the subsequent dose level according to the test data, but it will not exceed 100% dose increment. After the completion of DLT observation in each group, the next dose group and the number of cases were determined according to the safety, efficacy and PK data of the dose group. The traditional "3+3" method was used in the design of dose escalating stage, and the improved Fibonacci series was used for the dose increasing stage.
| Arm | Type | Receives |
|---|---|---|
| Dose escalation cohort of FCN-437c | Experimental | Drug: FCN-437c* This study plans to start escalating from 50 mg QD, through 100 mg, 200 mg, 300 mg, 450 mg, to 600 mg. * Participants will receive FCN-437c in sequential 28-day cycles which are made up of monotherapy QD for 21 days followed by a 7 day rest period. * Participants must be histologically or cytologically diagnosed with ER+/ HER2- advanced breast cancer. |
| Dose expansion cohort of FCN-437c + letrozole | Experimental | Drug: FCN-437c, Drug: Letrozole 2.5mg* The dose expansion stage will be initiated after escalating to MTD. * Six patients will be treated with FCN-437c combined with letrozole. * DLT assessment and PK blood collection will be completed in the first 28-day cycle. * If DLT does not occur in the first three patients, 15 additional patients were enrolled to complete the expansion study of MTD group. * If one DLT occurs in the first three patients, three additional patients will be enrolled onal patients were enrolled and completed the MTD group. * Patients will be evaluated every 8 weeks until disease progression, intolerable toxicity, death, investigator's decision or patient's voluntary withdrawal from the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Adult (>= 18 years old) patients diagnosed as ER +/ HER2 - advanced breast cancer, without standard treatment or unable to receive standard treatment;
- The eastern cooperative oncology group (ECOG) score is 0 or 1;
- According to RECIST version 1.1, there was at least one measurable lesion or only bone metastasis;
- The expected survival period is at least 12 weeks;
- Patients have sufficient bone marrow and organ function;
Key exclusion criteria (15 listed)
- HER2 + breast cancer, either defined as by fluorescence hybridization (FISH) or detected by standard immunohistochemistry (IHC);
- History of previous CDK4 / 6 inhibitors treatment;
- Received anti-tumor chemotherapy, major surgery, radiotherapy, biological drug therapy or other research drug treatment within 28 days before enrollment;
- The toxicity of previous anti-tumor therapy has not recovered (>= grade 2 according to NCI CTCAE version 5.0), except for hair loss; the neurotoxicity of patients who have received chemotherapy before should be restored to grade 2 or below based on NCI CTCAE version 5.0;
- The patient used CYP3A strong inhibitor or CYP3A inducer 14 days before the first dose administration;
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-437cAlso: Dose-escalation and expansion- 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. | Drug | Dose escalation cohort of FCN-437c, Dose expansion cohort of FCN-437c + letrozole |
| Letrozole 2.5mgAlso: Dose-escalation* Letrozole is the latest generation of aromatase inhibitor. Letrozole lowers estrogen levels in postmenopausal women, which may slow the growth of certain types of breast tumors that need estrogen to grow in the body. * Letrozole is used to treat breast cancer in postmenopausal women. It is often given to women who have been taking tamoxifen (Nolvadex, Soltamox) for 5 years. | Drug | Dose expansion cohort of FCN-437c + letrozole |
Primary outcome
DLT within 7 days of FCN-437c monotherapy
Time frame: 7 days
The incidence of DLT occurred within 7 days of FCN-437c monotherapy
DLT within 28 days of FCN-437c monotherapy
Time frame: 28 days
The incidence of DLT occurred within 28 days of FCN-437c monotherapy
DLT within 28 days of FCN-437c combined therapy
Time frame: 28 days
The incidence of DLT occurred within 28 days of the letrozole-combined treatment.
Adverse events until the last followup
Time frame: through study completion, assessed up to 24 months
The types and frequencies of adverse events (AEs) evaluated according to the National Cancer Institute Common Terminology Criteria for adverse events (NCI-CTCAE) version 5.0.
Serious and significant adverse events
Time frame: through study completion, assessed up to 24 months
Serious adverse events (SAE) and toxic reactions leading to permanent drug withdrawal occurred during the treatment.
Incidence of Deaths
Time frame: through study completion, assessed up to 24 months
The frequency and causes of deaths during the treatment.
Incidence of abnormal laboratory results
Time frame: through study completion, assessed up to 24 months
Abnormal laboratory results of safety concerns such as ALT, AST, Cr and BUN, et al according to NCI-CTCAE 5.0 classification.
Changes of ECGs from baselines
Time frame: through study completion, assessed up to 24 months
Changes of ECGs from baselines, such as QT interval。
11 secondary outcomes
Anti-tumor efficacy of monotherapy
Time frame: through study completion, assessed up to 24 months
Anti-tumor efficacy of combined treatment
Time frame: through study completion, assessed up to 24 months
FPS
Time frame: through study completion, assessed up to 24 months
OS
Time frame: through study completion, assessed up to 24 months
survival rate
Time frame: through study completion, assessed up to 24 months
DOR
Time frame: through study completion, assessed up to 24 months
CBR
Time frame: through study completion, assessed up to 24 months
Cmax of FCN-437c in monotherapy
Time frame: through study completion, assessed up to 24 months
AUC of FCN-437c in monotherapy
Time frame: through study completion, assessed up to 24 months
Cmax of FCN-437c in combined treatment
Time frame: through study completion, assessed up to 24 months
AUC of FCN-437c in combined treatment
Time frame: through study completion, assessed up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2020.
- Background: PubMed 27336726Curigliano G, Gomez Pardo P, Meric-Bernstam F, Conte P, Lolkema MP, Beck JT, Bardia A, Martinez Garcia M, Penault-Llorca F, Dhuria S, Tang Z, Solovieff N, Miller M, Di Tomaso E, Hurvitz SA. Ribociclib plus letrozole in early breast cancer: A presurgical, window-of-opportunity study. Breast. 2016 Aug;28:191-8. doi: 10.1016/j.breast.2016.06.008. Epub 2016 Jun 20.
- Background: PubMed 27542767Infante JR, Cassier PA, Gerecitano JF, Witteveen PO, Chugh R, Ribrag V, Chakraborty A, Matano A, Dobson JR, Crystal AS, Parasuraman S, Shapiro GI. A Phase I Study of the Cyclin-Dependent Kinase 4/6 Inhibitor Ribociclib (LEE011) in Patients with Advanced Solid Tumors and Lymphomas. Clin Cancer Res. 2016 Dec 1;22(23):5696-5705. doi: 10.1158/1078-0432.CCR-16-1248. Epub 2016 Aug 19.
- Background: PubMed 26991823Tamura K, Mukai H, Naito Y, Yonemori K, Kodaira M, Tanabe Y, Yamamoto N, Osera S, Sasaki M, Mori Y, Hashigaki S, Nagasawa T, Umeyama Y, Yoshino T. Phase I study of palbociclib, a cyclin-dependent kinase 4/6 inhibitor, in Japanese patients. Cancer Sci. 2016 Jun;107(6):755-63. doi: 10.1111/cas.12932. Epub 2016 May 11.
- Background: PubMed 19097774Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.
- Background: PubMed 25278265Elsasser A, Regnstrom J, Vetter T, Koenig F, Hemmings RJ, Greco M, Papaluca-Amati M, Posch M. Adaptive clinical trial designs for European marketing authorization: a survey of scientific advice letters from the European Medicines Agency. Trials. 2014 Oct 2;15:383. doi: 10.1186/1745-6215-15-383.
- Derived from this study: PubMed 34109484Zhang J, Wang X, Wang X, Hui A, Wu Z, Tian L, Xu C, Yang Y, Zhang W, Hu X. Phase 1a study of the CDK4/6 inhibitor, FCN-437c, in Chinese patients with HR + /HER2- advanced breast cancer. Invest New Drugs. 2021 Dec;39(6):1549-1558. doi: 10.1007/s10637-021-01133-2. Epub 2021 Jun 9.
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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.
Jian Zhang, M.D. contact
Xichun Hu, M.D. 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 1/2 study testing FCN-437c and Letrozole 2.5mg in people with Breast Neoplasms, run by Ahon Pharmaceutical Co., 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 11 inclusion and 15 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 27 Jul 2020. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Xichun Hu, M.D. (13816110335, xchu2009@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT within 7 days of FCN-437c monotherapy (time frame: 7 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04488107, which also lists 6 linked publications.
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 27 Jul 2020.