BridgeMD
Tests treatment safety and results for Recurrent Ovarian Cancer
Official title Efficacy and Safety of CapsuleX Combined With Cisplatin in Platinum-Resistant Recurrent Ovarian Cancer: A Single-Arm Prospective Clinical Study
ClinicalTrials.gov ID: NCT07495384
What this study is testing
What is CapsuleX?
CapsuleX is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for recurrent ovarian cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This trial was designed as a single-arm, open-label, prospective clinical trial to evaluate the efficacy (ORR) and safety (AE incidence) of CapsuleX in combination with cisplatin for platinum-resistant recurrent ovarian cancer (PROC).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- The subject can understand the informed consent, voluntarily participate and sign the informed consent;
- The subject is at least 18 years old on the day of signing the informed consent;
- people with histologically confirmed epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer;
- Platinum resistance is defined as: a. For people who have only received first-line platinum-based therapy, they must have received at least four...
- The subject must have had progression or intolerance during or after the most recent treatment;
You likely can't join if
- Primary platinum-refractory is defined as disease that has not been relieved (CR) during first-line platinum-containing chemotherapy or within 3...
- History of active central nervous system metastasis, leptomeningeal metastasis or carcinomatous meningitis with stable evaluation by the investigator...
- Received any investigational drug within 28 days prior to randomization;
- Five half-lives (the shorter time) within 28 days prior to randomization of other antitumor therapy or antitumor drugs Equivalent but at least 14...
- Received local palliative treatment within 14 days prior to randomization;
- Had major surgery (such as abdominal or thoracic surgery; not including diagnostic surgery) within 28 days prior to randomization Small operations...
See the full eligibility criteria
Who can join
- The subject can understand the informed consent, voluntarily participate and sign the informed consent;
- The subject is at least 18 years old on the day of signing the informed consent;
- people with histologically confirmed epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer;
- Platinum resistance is defined as: a. For people who have only received first-line platinum-based therapy, they must have received at least four cycles of platinum-based therapy and achieved disease response (CR or PR)...
- The subject must have had progression or intolerance during or after the most recent treatment;
- Previous 2-3 line systemic antitumor therapy, with progression within \<6 months after the last platinum treatment and ≥3 months Note: a. New adjuvant and/or adjuvant therapy combined as line 1 treatment; b. Maintenance...
- According to RECIST 1.1, the baseline should have at least 1 measurable lesion. Measurable lesions should not have been previously received Local treatment (such as radiotherapy), or evidence of disease progression...
- Expected survival time is greater than or equal to 6 months;
- ECOG score 0 or 1;
- Sufficient organ/marrow function within 7 days prior to randomization, asdefined below;
- Willing to provide archived or fresh tumor tissue samples (if no archived tumor tissue is available and the investigator assesses that it would be risky for the subject to retrieve primary or metastatic tumor tissue...
- Able to understand the test requirements and willing and able to comply with the test and follow-up procedures.
What rules you out
- Primary platinum-refractory is defined as disease that has not been relieved (CR) during first-line platinum-containing chemotherapy or within 3 months after the last dose Or PR) or imaging progression;
- History of active central nervous system metastasis, leptomeningeal metastasis or carcinomatous meningitis with stable evaluation by the investigator Excluding brain parenchyma metastases, stability is defined by the...
- Received any investigational drug within 28 days prior to randomization;
- Five half-lives (the shorter time) within 28 days prior to randomization of other antitumor therapy or antitumor drugs Equivalent but at least 14 days); Received Chinese herbal medicine with a clear anti-tumor...
- Received local palliative treatment within 14 days prior to randomization;
- Had major surgery (such as abdominal or thoracic surgery; not including diagnostic surgery) within 28 days prior to randomization Small operations such as puncture or infusion device implantation or biliary stent...
- There are obvious clinical manifestations of gastrointestinal abnormalities, including but not limited to: intestinal obstruction existed or existed within 3 months before administration Symptoms and signs of intestinal...
- Uncontrolled and recurrent (recurrent within 2 weeks of intervention) moderate to large pleural effusions such as the chest people with water, pericardial effusion, ascites and cachexia;
- Other malignant tumors were combined within the previous 5 years, excluding curable squamous cell carcinoma of skin, basal cell carcinoma and non-basal infiltration Bladder cancer with lubrication, in situ...
- Past or current interstitial pneumonia/pulmonary disease requiring systemic glucocorticoid therapy, or imaging during screening The examination could not rule out suspected interstitial pneumonia/pulmonary disease;
- The presence of uncontrolled comorbidities, including but not limited to:
- Active HBV or HCV infection. HBsAg (+), HBV-DNA \<2500 copies/mL or 500 Enrollment is allowed at IU/mL; enrollment is allowed if HCV-Ab (+) and HCV-RNA test is negative;
- HIV infection;
- Known active tuberculosis;
- Active syphilis;
- There is an active or uncontrolled infection within 2 weeks prior to the randomization, and systemic antimicrobial therapy is required;
- Uncontrolled hypertension (systolic blood pressure ≥180mmHg, diastolic blood pressure\> 100 mmHg) and symptomatic heart failure Full (NYHA II-IV), refractory hypokalemia, long QT syndrome, moderate to severe pulmonary...
- Severe arrhythmias of important medical significance, including but not limited to ventricular tachycardia, ventricular fibrillation, and apex torsion A history of transition tachycardia, complete left or right bundle...
- Unstable angina or myocardial infarction within 6 months;
- New diagnosis of a treatable thromboembolic event within 6 months (control of stable lower extremity deep vein thrombosis or infusion Thrombosis people such as liquid ports are allowed to be included)
- The toxicity of previous anti-tumor therapy has not been restored to CTCAE≤1 grade (NCI-CTCAE v5.0); Note: Participants with stable grade CTCAE 2 toxicity related to prior anti-tumor therapy can be enrolled (defined as...
- Previous history of allogeneic bone marrow or organ transplantation;
- History of previous allergic reactions to antibody drugs and hypersensitivity reactions;
- Other researchers believe that conditions that may affect the safety or compliance of treatment with the study drug, including but not limited to mental illness Class diseases, alcoholism or drug abuse, etc.
The study team makes the final eligibility decision.
Where it's taking place
- Changchun, Jilin, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Changchun, Jilin, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.