Recurrent Ovarian CarcinomaPhase 2NCT06243185
Dalpiciclib Combined With Letrozole in HR+/HER2 - Gynecologic Solid Tumors
A Phase 2 study testing Dalpiciclib plus letrozole in people with Recurrent Ovarian Carcinoma, run by Fengzhi Feng at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Recurrent Ovarian Carcinoma
- What is being tested?
- Dalpiciclib plus letrozole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 17 Nov 2023to 30 Jun 2025
- Phase
- Phase 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged ≥18 years and ≤75 years;
- Women with pathologically confirmed HR-positive, HER2-negative ovarian cancer or uterine tumors (including but not limited to high-grade serous ovarian cancer, low-grade serous ovarian cancer, ovarian endometrioid cancer, endometrioid cancer, low -grade endometrial stromal sarcoma, and uterine leiomyosarcoma) with evidence of focal recurrence or metastasis; Non-curative surgical resection or radiation therapy failing standard treatment, and no standard chemotherapy regimen. Er-positivity and/or PR-positive tumor cells were defined as 1% or more of all tumor cells that stained positively (as confirmed by the site investigator). Her2-negative was defined as 0/1+ on standard immunohistochemical (IHC) testing; An HER2/CEP17 ratio of less than 2.0 or a HER2 gene copy number of less than 4, as assessed by in situ hybridization (ISH), was confirmed by site investigator review.
- Receipt of any previous systemic anticancer therapy for focal recurrent or metastatic disease.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Measurable lesions meeting RECIST 1.1 criteria or bone-only metastatic lesions (including osteolytic lesions or mixed osteolytic/osteogenic lesions).
- Adequate organ and bone marrow function, defined as neutrophil count (ANC) ≥ 1500/mm3(1.5 × 109/L) (no growth factor administration within 14 days); Platelet count (PLT) ≥ 100,000/mm3 (100 × 109/L) (no corrective therapy within 7 days); Hemoglobin (Hb) ≥ 9 g/dL (90 g/L) (no corrective therapy used within 7 days); Serum creatinine ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance ≥ 60 ml/min; Total bilirubin (BIL) ≤ 1.5 times upper limit of normal value (ULN); Aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT) ≤ 2.5 times The upper limit of normal (ULN), patients with liver metastases should be ≤ 5×ULN.
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- Use of a medically approved contraceptive method (e.g., an intrauterine device, contraceptive pill, or condom) during the study treatment period and for 3 months after the end of the study treatment period for patients with potential childbearing potential; A negative serum HCG test must have been performed within 72 hours before study entry; And had to be non-lactating.
- All acute toxic effects prior to antineoplastic therapy resolved to grade 0-1 (according to NCICTCAE version 5.0) or to the level specified in the inclusion/exclusion criteria. Other toxicities, such as alopecia, that were deemed by the investigators not to pose a safety risk to patients were excluded.
- There is no limit to the number of previous lines of endocrine therapy.
- The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
Zhi f Feng, PhD contact
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Xiao Shang, PhD, 13810073050, shang.mm@163.com
Zhi f Feng, PhD, fengfz1969@sina.com
About this study
Official title: A Phase II Study of the CDK4/6 Inhibitor Dalpiciclib Combined With Letrozole in Unresectable Refractory or Resistant Recurrent HR+/HER2 - Gynecologic Solid Tumors
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.
- Conditions
- Recurrent Ovarian Carcinoma
- Being tested
- Dalpiciclib plus letrozole
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dalpiciclib plus letrozoleDrug
Dalpiciclib 150mg qd, d1-21, repeated once every 4 weeks. Letrozole 2.5mg qd, repeated once every 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Dalpiciclib+letrozole | Experimental | Drug: Dalpiciclib 150mg qd, d1-21, q4w Letrozole 2.5mg qd, q4w Receives: Drug: Dalpiciclib plus letrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month PFS rate
according to RECIST1.1 criteria,the percent of participant whose PFS is more than 6 months
Measured: From the start of randomization to 6 months
Secondary outcomes (5)
Progression-free survival(PFS)
Time from initiation of study protocol treatment to disease progression or death
Measured: From the start of randomization to a minimum of 1 year
Objective Response Rate（ORR）
Percentage of patients with CR/PR in the number of patients that whose tumour can be evaluated.
Measured: 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.
Measured: 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
Measured: 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.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start17 Nov 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Ovarian CarcinomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fengzhi Feng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fengzhi Feng, Peking Union Medical College Hospital
- Investigators
- Zhi f Feng, PhD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06243185
- Sponsor's protocol ID
- K4823
- Status last verified
- Feb 2024
- First submitted
- 9 Jan 2024
- Last updated
- 6 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of the CDK4/6 Inhibitor Dalpiciclib Combined With Letrozole in Unresectable Refractory or Resistant Recurrent HR+/HER2 - Gynecologic Solid Tumors
- ClinicalTrials.gov ID
- NCT06243185
- Acronym / sponsor ID
- K4823
- Conditions
- Recurrent Ovarian Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fengzhi FengUniversity, hospital or other
- Study start
- 17 Nov 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 6 Feb 2024 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dalpiciclib+letrozole | Experimental | Drug: Dalpiciclib plus letrozoleDrug: Dalpiciclib 150mg qd, d1-21, q4w Letrozole 2.5mg qd, q4w |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Female patients aged ≥18 years and ≤75 years;
- Women with pathologically confirmed HR-positive, HER2-negative ovarian cancer or uterine tumors (including but not limited to high-grade serous ovarian cancer, low-grade serous ovarian cancer, ovarian endometrioid cancer, endometrioid cancer, low -grade endometrial stromal sarcoma, and uterine leiomyosarcoma) with evidence of focal recurrence or metastasis; Non-curative surgical resection or radiation therapy failing standard treatment, and no standard chemotherapy regimen. Er-positivity and/or PR-positive tumor cells were defined as 1% or more of all tumor cells that stained positively (as confirmed by the site investigator). Her2-negative was defined as 0/1+ on standard immunohistochemical (IHC) testing; An HER2/CEP17 ratio of less than 2.0 or a HER2 gene copy number of less than 4, as assessed by in situ hybridization (ISH), was confirmed by site investigator review.
- Receipt of any previous systemic anticancer therapy for focal recurrent or metastatic disease.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Measurable lesions meeting RECIST 1.1 criteria or bone-only metastatic lesions (including osteolytic lesions or mixed osteolytic/osteogenic lesions).
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| Dalpiciclib plus letrozoleDalpiciclib 150mg qd, d1-21, repeated once every 4 weeks. Letrozole 2.5mg qd, repeated once every 4 weeks. | Drug | Dalpiciclib+letrozole |
Primary outcome
6-month PFS rate
Time frame: From the start of randomization to 6 months
according to RECIST1.1 criteria,the percent of participant whose PFS is more than 6 months
5 secondary outcomes
Progression-free survival(PFS)
Time frame: From the start of randomization to a minimum of 1 year
Objective Response Rate（ORR）
Time frame: From the start of randomization to a minimum of 1 year
Disease Control Rate (DCR)
Time frame: From the start of randomization to a minimum of 1 year
Duration of response（DOR）
Time frame: From the start of randomization to a minimum of 1 year
Overall Survival(OS)
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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.
Zhi f Feng, PhD contact
Zhi f Feng, PhD principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dalpiciclib plus letrozole in people with Recurrent Ovarian Carcinoma, run by Fengzhi Feng 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 10 inclusion and 9 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 6 Feb 2024. 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 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 Xiao Shang, PhD (13810073050, shang.mm@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-month PFS rate (time frame: From the start of randomization to 6 months). 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 6 Feb 2024; AzTrials last refreshed its copy on 6 Nov 2026.