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This is a prospective, single-arm, single-center registry study to investigate 6-month progression-free survival with Dalpiciclib, a CDK4/6 kinase inhibitor, plus letrozole in patients with unresectable refractory or resistant recurrent HR-positive, HER2-negative gynecologic solid tumors." Dalpiciclib is a CDK4/6 kinase inhibitor that selectively inhibits the activity of CDK4/6 kinase, so that the complex with Cyclin D cannot phosphorylate the downstream Rb protein and prevent cells from entering the S phase from G1 phase, thereby inhibiting cell proliferation and anti-tumor effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dalpiciclib+letrozole | Experimental | Drug: Dalpiciclib 150mg qd, d1-21, q4w Letrozole 2.5mg qd, q4w |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dalpiciclib plus letrozole | Drug | Dalpiciclib 150mg qd, d1-21, repeated once every 4 weeks. Letrozole 2.5mg qd, repeated once every 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 6-month PFS rate | according to RECIST1.1 criteria,the percent of participant whose PFS is more than 6 months | From the start of randomization to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival(PFS) | Time from initiation of study protocol treatment to disease progression or death | From the start of randomization to a minimum of 1 year |
| Objective Response Rate(ORR) |
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Inclusion Criteria:
Exclusion Criteria:
1. Previous pathological diagnosis of HER2-positive. Patients who were not candidates for endocrine therapy as judged by the investigator. "Patients were included who were symptomatic, had spread to the viscera, and were at risk for life-threatening complications in the short term (including patients with uncontrolled massive exudates [thoracic, pericardial, abdominal], pulmonary lymphangitis, and more than 50% liver involvement)." 3.Patients with brain metastases diagnosed by head CT or MRI. 4.Patients had received any previous CDK4/6 inhibitor therapy. 5.Major surgery, chemotherapy, radiation therapy, any investigational drug, or other anticancer treatment within 2 weeks before study entry.
6.Any other malignancy was diagnosed within 3 years before study entry, except nonmelanoma skin cancer, basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix treated with curative intent 7.Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA ≥1000 IU/ml), hepatitis C (positive hepatitis C antibody and HCV-RNA higher than the lower limit of detection of the assay), or co-infection with hepatitis B and C.
8.In the 6 months prior to study entry, the following occurred: Myocardial infarction, severe
or unstable angina, cardiac dysfunction of NYHA class 2 or higher, persistent arrhythmia of class 2 or higher (according to NCICTCAE, version 5.0), atrial fibrillation of any grade, coronary or peripheral artery bypass grafting, symptomatic congestive heart failure, or cerebrovascular accident (including transient ischemic attack or symptomatic pulmonary embolism).
9.Severe infection (e.g., intravenous antibiotics, antifungal, or antiviral agents according to standard practice) within 4 weeks before the first dose or unexplained fever >38.5oC during screening/before the first dose.
10.Inability to swallow, intestinal obstruction, or other factors affecting drug administration and absorption.
11.Known allergies to letrozole or anastrozole, LHRH agonist (goserelin), SHR6390/ placebo, or any excipients.
12.Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
13.Known history of psychotropic drug abuse or drug use. 14.Patients with other serious physical or mental illnesses or laboratory abnormalities that may increase the risk of participating in the study or interfere with the study results, and those who are considered by the investigator to be unsuitable for participation in the study
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiao Shang, PhD | Contact | 13810073050 | shang.mm@163.com | |
| Zhi f Feng, PhD | Contact | fengfz1969@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhi f Feng, PhD | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100730 | China |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| C000720752 | dalpiciclib |
| D000077289 | Letrozole |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 |
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Percentage of patients with CR/PR in the number of patients that whose tumour can be evaluated.
| From the start of randomization to a minimum of 1 year |
| Disease Control Rate (DCR) | Percentage of patients with CR/PR/SD in the number of patients that whose tumour can be evaluated. | From the start of randomization to a minimum of 1 year |
| Duration of response(DOR) | The time between the onset of efficacy and confirmation of tumor progression | From the start of randomization to a minimum of 1 year |
| Overall Survival(OS) | The time from the start of treatment with this study protocol to the time of all-cause death of patients. | up to 2 years |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |