Actively Recruiting
A Multi-center, Double-blind, Randomized Phase III Trial of Chiauranib Plus Weekly Paclitaxel in Women with Platinum-refractory or Platinum-resistant Recurrent Ovarian Cancer
Led by Chipscreen Biosciences, Ltd. · Updated on 2024-10-18
454
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of Chiauranib combined with weekly paclitaxel compared to placebo plus weekly paclitaxel in women with platinum-refractory or platinum-resistant recurrent ovarian cancer. This phase III, randomized, double-blind study focuses on patients whose cancer progressed during or shortly after platinum-based therapy, aiming to understand the treatment's impact on disease progression and survival. Participants are randomly assigned to receive either Chiauranib oral tablets at 50mg once daily plus intravenous paclitaxel on days 1, 8, and 15 of a 21-day cycle, or placebo tablets plus the same paclitaxel regimen. The combined treatment lasts up to six cycles. Those with stable disease or response after six cycles continue on single-agent Chiauranib or placebo until disease progression. During the study, participants undergo assessments including measuring tumor lesions, blood tests, and monitoring for side effects. The main outcomes measured are progression-free survival for up to one year and overall survival for up to two years. Additional outcomes include response rates, quality of life, and drug pharmacokinetics. Safety is closely monitored throughout the trial, which is expected to complete by July 2025.
CONDITIONS
Brief Title
Chiauranib Plus Weekly Paclitaxel in Patients with Platinum-refractory or Platinum-resistant Recurrent Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willingness to sign a written informed consent document.
- Female, age 18 years and older up to 70 years.
- Histological or cytological confirmation of epithelial ovarian cancer, carcinoma tube, or primary peritoneal carcinoma.
- Platinum refractory or platinum resistant ovarian cancer as defined by progression during or shortly after platinum-based treatment.
- Radiological progression during the last treatment administered.
- No more than 1 prior treatment regimen for recurrent disease.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- At least 1 measurable lesion according to RECIST1.1.
- Laboratory values within defined limits for blood counts, liver and kidney function, and coagulation.
- Life expectancy of at least 3 months.
You will not qualify if you...
- Prior treatment with VEGF/VEGFR inhibitors or Aurora kinase inhibitors.
- Prior weekly paclitaxel therapy.
- Known allergies to Chiauranib, paclitaxel, or study excipients.
- Recent biological, immuno-, or hormonal therapy within 28 days before study drug.
- Major surgery or trauma within 14 days before study drug or presence of non-healing wounds.
- Treatment with other investigational agents within 28 days before study drug.
- Ongoing toxicity from previous cancer therapy greater than Grade 1.
- Prior invasive malignancies within 5 years except certain skin or cervical cancers.
- History or evidence of central nervous system metastases.
- Significant nervous system diseases.
- Uncontrolled or significant cardiovascular diseases including heart failure, unstable angina, recent heart attack, arrhythmia, cardiomyopathies, prolonged QT interval, symptomatic coronary heart disease, or hypertension requiring multiple medications.
- Recent serious blood clots.
- Recent active bleeding or need for anticoagulation therapy.
- Lung diseases like interstitial lung disease, pulmonary fibrosis, or recent pneumonia requiring steroids.
- Gastrointestinal conditions affecting oral drug absorption or recent GI surgeries.
- Significant pleural, pericardial effusions or ascites requiring treatment.
- Positive screening for HIV, hepatitis B or C with active virus replication.
- Active infections needing systemic antimicrobial therapy.
- Mental or cognitive disorders impairing consent or compliance.
- History of organ transplantation or bone marrow transplant.
- Drug or alcohol abuse.
- Pregnancy, breastfeeding, or unwillingness to use contraception.
- Any other condition deemed inappropriate by investigators.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 18 weeks for combined treatment followed by continued daily oral treatment until progression
Participants receive combined treatment with paclitaxel and either Chiauranib or placebo. Paclitaxel is given by intravenous infusion on Days 1, 8, and 15 of each 21-day cycle for up to 6 cycles. Chiauranib or placebo is taken orally once daily throughout the treatment cycles. After completing 6 cycles, participants with stable disease or better continue daily oral Chiauranib or placebo alone until disease progression.
Weekly visits during combined treatment cycles; visits frequency during single agent treatment depends on clinical assessments
Duration - Up to 2 years
Participants are monitored for progression-free survival and overall survival, along with assessments of response, disease control, quality of life, and safety for up to 2 years after treatment.
Periodic visits for assessments during follow-up
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, China, China, 200032
Actively Recruiting
Research Team
Y
Yu Chen
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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