Ovarian CancerPhase 2NCT06552858
Fluzoparib Combined With Dalpiciclib for Platinum Resistant Recurrent Ovarian Cancer
A Phase 2 study testing Fluzoparib and Dalpiciclib in people with Ovarian Cancer, run by Fudan University at 1 site in China.
Trial summary
This study aims to investigate the safety and efficacy of combination therapy of Fluzoparib combined With Dalpiciclib for platinum-resistant recurrent ovarian cancer through a single-center, prospective, single-arm, phase II clinical trial, to improve the overall treatment level and prognosis of platinum-resistant… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Fluzoparib and Dalpiciclib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2024to 31 Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Age≥18 years old;
- Sign the informed consent form;
- Histologically-confirmed epithelial ovarian or fallopian-tube cancer or primary peritoneal cancer.
- Tumor recurrence or progression within 6 months after using platinum-based drugs;
Who cannot join
- Any uncontrolled medical condition that may put the patient at high risk during treatment .
- Receipt of any other investigational medicinal product within the last 30 days before randomization.
- Patients with ovarian cancer excluded by pathological or clinical diagnosis;
- Physical intolerance patients;
- Patients who are unwilling to participate in the clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Fudan university shanghai cancer center, Deparment of gynecologic oncology
Shanghai, Shanghai Municipality, 200000
About this study
Official title: Fluzoparib Combined With Dalpiciclib for Platinum Resistant Recurrent Ovarian Cancer: a Phase II Clinical Study
This study aims to investigate the safety and efficacy of combination therapy of Fluzoparib combined With Dalpiciclib for platinum-resistant recurrent ovarian cancer through a single-center, prospective, single-arm, phase II clinical trial, to improve the overall treatment level and prognosis of platinum-resistant ovarian cancer.
Read the detailed description
- Overall Design: This trial is a single-center, prospective, single-arm, phase II clinical trial to evaluate the safety and efficacy of combination therapy of Fluzoparib combined With Dalpiciclib for platinum-resistant recurrent ovarian cancer.
- Experimental observation indicators: 1) Main indicators: progression-free survival (PFS), 2) Other indicators: overall survival (OS), objective response rate (ORR), and adverse reactions.
- Sample size calculation: The median PFS of platinum-resistant recurrent ovarian cancer patients is 3.8 months. In comparison, the experimental group is expected to have a median PFS of 7 months, with an alpha value of 0.05. Following up for 1 year and considering a 10% dropout rate, this study plans to include 30 platinum-resistant recurrent ovarian cancer patients.
- Data Processing: Enter data and use SPSS statistical software for statistical analysis. Statistical analyst: Clinical Statistics Department of Fudan University Cancer Hospital. Mailing address: 270 Dong'an Road, Shanghai.
- Conditions
- Ovarian Cancer
- Being tested
- Fluzoparib, Dalpiciclib
- Keywords
- ovarian cancer, platinum resistance, Fluzoparib, Dalpiciclib
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluzoparibDrug
150mg oral bid. A PARP inhibitor that mainly exerts its inhibitory effect on tumor cells by inhibiting DNA repair.
DalpiciclibDrug
150mg oral qd d1-21, q4w. Inhibitor of Cyclin D-CDK4/6 that can inhibit the cell cycle, thereby inducing cell apoptosis.
| Study group | Role | What they receive |
|---|---|---|
| Fluzoparib with Dalpiciclib | Experimental | Oral administration of Fluzoparib with Dalpiciclib until disease progression or toxicity intolerance. Receives: Drug: Fluzoparib; Drug: Dalpiciclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression free survival
Measured: Two years
Secondary outcomes (2)
OS
Overall Survival
Measured: Two years
ORR
Overall Remission Rate
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaohua Wu MD [zzhong], Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06552858
- Sponsor's protocol ID
- FD-OCR-2024
- Status last verified
- Aug 2024
- First submitted
- 11 Aug 2024
- Last updated
- 14 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluzoparib Combined With Dalpiciclib for Platinum Resistant Recurrent Ovarian Cancer: a Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT06552858
- Acronym / sponsor ID
- FD-OCR-2024
- Conditions
- Ovarian Cancer
- Keywords
- ovarian cancer, platinum resistance, Fluzoparib, Dalpiciclib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 14 Aug 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 study aims to investigate the safety and efficacy of combination therapy of Fluzoparib combined With Dalpiciclib for platinum-resistant recurrent ovarian cancer through a single-center, prospective, single-arm, phase II clinical trial, to improve the overall treatment level and prognosis of platinum-resistant ovarian cancer.
Detailed description
- Overall Design: This trial is a single-center, prospective, single-arm, phase II clinical trial to evaluate the safety and efficacy of combination therapy of Fluzoparib combined With Dalpiciclib for platinum-resistant recurrent ovarian cancer.
- Experimental observation indicators: 1) Main indicators: progression-free survival (PFS), 2) Other indicators: overall survival (OS), objective response rate (ORR), and adverse reactions.
- Sample size calculation: The median PFS of platinum-resistant recurrent ovarian cancer patients is 3.8 months. In comparison, the experimental group is expected to have a median PFS of 7 months, with an alpha value of 0.05. Following up for 1 year and considering a 10% dropout rate, this study plans to include 30 platinum-resistant recurrent ovarian cancer patients.
- Data Processing: Enter data and use SPSS statistical software for statistical analysis. Statistical analyst: Clinical Statistics Department of Fudan University Cancer Hospital. Mailing address: 270 Dong'an Road, Shanghai.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluzoparib with Dalpiciclib | Experimental | Drug: Fluzoparib, Drug: DalpiciclibOral administration of Fluzoparib with Dalpiciclib until disease progression or toxicity intolerance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age≥18 years old;
- Sign the informed consent form;
- Histologically-confirmed epithelial ovarian or fallopian-tube cancer or primary peritoneal cancer.
- Tumor recurrence or progression within 6 months after using platinum-based drugs;
Key exclusion criteria (5 listed)
- Any uncontrolled medical condition that may put the patient at high risk during treatment .
- Receipt of any other investigational medicinal product within the last 30 days before randomization.
- Patients with ovarian cancer excluded by pathological or clinical diagnosis;
- Physical intolerance patients;
- Patients who are unwilling to participate in the clinical trial.
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 |
|---|---|---|
| Fluzoparib150mg oral bid. A PARP inhibitor that mainly exerts its inhibitory effect on tumor cells by inhibiting DNA repair. | Drug | Fluzoparib with Dalpiciclib |
| Dalpiciclib150mg oral qd d1-21, q4w. Inhibitor of Cyclin D-CDK4/6 that can inhibit the cell cycle, thereby inducing cell apoptosis. | Drug | Fluzoparib with Dalpiciclib |
Primary outcome
PFS
Time frame: Two years
Progression free survival
2 secondary outcomes
OS
Time frame: Two years
ORR
Time frame: Two years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Ovarian Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
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.
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 Fluzoparib and Dalpiciclib in people with Ovarian Cancer, run by Fudan University 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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 14 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xingzhu Ju, MD (+86 18601684480, a610278155@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: Two years). 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 14 Aug 2024.