Actively Recruiting
A Multicenter, Randomized, Double-Blind Phase II Study of IN10018 With Pegylated Liposomal Doxorubicin Versus Placebo With PLD for Platinum-Resistant Recurrent Ovarian Cancer
Led by InxMed (Shanghai) Co., Ltd. · Updated on 2025-04-30
168
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of IN10018 combined with Pegylated Liposomal Doxorubicin (PLD) compared to placebo combined with PLD in women with platinum-resistant recurrent ovarian cancer, including fallopian tube and primary peritoneal cancers. This multicenter, randomized, double-blind Phase II study aims to improve treatment options for this condition by comparing these two approaches. Approximately 168 female participants will be randomly assigned in a 2:1 ratio to receive either IN10018 100 mg orally once daily with PLD 40 mg/m2 intravenously every 4 weeks, or a placebo alongside PLD at the same dose and schedule. Participants are stratified based on prior bevacizumab use and the time since their last platinum-based therapy. The study follows strict protocols to monitor these treatments throughout the trial. Participants will undergo various assessments including tumor imaging to measure progression-free survival and other outcomes using RECIST 1.1 criteria, evaluated by independent reviewers and investigators over two years. Safety and tolerability will also be monitored. The study will last through treatment and follow-up phases, with overall survival tracked for up to three years. Regular health evaluations, laboratory tests, and performance status assessments will support participant monitoring throughout the trial.
CONDITIONS
Brief Title
IN10018 in Combination With Pegylated Liposomal Doxorubicin (PLD) vs. Placebo in Combination With PLD for the Treatment of Platinum-resistant Recurrent Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female subjects 18 years or older at the time of signing informed consent
- Histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal cancer with high-grade serous carcinoma subtype
- Received platinum-containing therapy with relapse or progression during treatment or within 6 months after completion
- Maximum of 3 prior systemic therapy lines allowed (excluding certain maintenance therapies)
- At least one measurable lesion per RECIST 1.1 criteria
- ECOG performance status of 0 or 1
- Life expectancy of at least 3 months
- Availability of archival or fresh tumor tissue sample during screening
- Recovery from prior therapy adverse events to Grade 1 or stable status
- Adequate bone marrow, liver, renal, and coagulation function within 7 days prior to randomization
- Not pregnant, not breastfeeding, and meet contraceptive requirements if woman of childbearing potential
You will not qualify if you...
- Major surgery or significant injury within 28 days prior to randomization, or diagnostic biopsy within 14 days unless deemed not to affect evaluation
- Received systemic anticancer therapy or investigational agents within specified recent timeframes prior to randomization
- Prior radiotherapy within 14 days prior to randomization (with limited exceptions)
- Prior treatment with any FAK inhibitor or Pegylated Liposomal Doxorubicin
- Known other cancers distinct from ovarian cancer within 3 years, except certain treated cancers
- Active central nervous system metastases or carcinomatous meningitis
- Major cardiovascular, cerebrovascular, or thromboembolic diseases within 6 months or related heart abnormalities
- Symptomatic pleural, pericardial effusion or ascites requiring drainage within 3 months
- Malabsorption syndrome or inability to take oral drugs
- Uncontrolled gastrointestinal diseases or bleeding
- Evidence of intestinal obstruction or recurrent ileus
- Interstitial pneumonia except certain radiation-related cases
- Uncontrolled active infection
- Known HIV, active Hepatitis B or C infection
- Psychiatric or substance abuse disorders interfering with study participation
- Allergy or hypersensitivity to study drugs
- Prior cumulative anthracycline dose ≥ 550 mg/m2
- Recent use or planned use of strong CYP3A4, CYP2D6, or P-gp inhibitors/inducers within 14 days prior to randomization
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 - Repeated 4-week cycles until disease progression or discontinuation
Participants receive either IN10018 plus Pegylated Liposomal Doxorubicin or placebo plus Pegylated Liposomal Doxorubicin as study treatment.
1 visit every 4 weeks for drug administration
Duration - Up to 2 years
Participants are monitored for safety and disease status after treatment ends.
Visits scheduled as per protocol for assessments during follow-up period
Trial Site Locations
Total: 1 location
1
Cancer Hospital Chinese Academy of Medical Science and Peking Union Medical College
Beijing, China
Actively Recruiting
Research Team
S
Shangyu CHEN, N/A
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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