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New treatment option for Ovarian Cancer Recurrent
Official title IN10018 in Combination With Pegylated Liposomal Doxorubicin (PLD) vs. Placebo in Combination With PLD for the Treatment of Platinum-resistant Recurrent Ovarian Cancer
ClinicalTrials.gov ID: NCT06014528
What this study is testing
What is IN10018?
IN10018 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for ovarian cancer recurrent.
Also referred to as BI 853520.
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 is a multicenter, randomized, double-blind, phase II clinical study to evaluate the efficacy and safety of IN10018 in combination with PLD vs. placebo in combination with PLD in subjects with platinum-resistant recurrent ovarian cancer (including fallopian tube and primary peritoneal cancers).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
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
- Ability to understand and willingness to sign informed consent(s). Signed informed consent must be obtained before any study specific procedures...
- Female people ≥ 18 years at the time of signing informed consent.
- Histologically confirmed epithelial ovarian cancer, fallopian tube cancer or primary peritoneum cancer and its subtype is high-grade serous carcinoma...
- Have received platinum containing therapy and have radiological relapse or progression during platinum containing treatment or \< 6 months (184...
- Maximum total of 3 prior lines of systemic therapy are allowed. Note: Hormonal therapies (e.g., tamoxifen), PARP inhibitors and bevacizumab given in...
You likely can't join if
- Has had major surgery or significant traumatic injury within 28 days prior to randomization, or diagnostic biopsies within 14 days prior to...
- Has received prior systemic anticancer therapy including investigational agents, such as within 14 days or less than 5 half-lives (whichever is...
- Has received prior radiotherapy within 14 days prior to randomization. Note: A 7-day washout is permitted for palliative radiation (≤ 14 days of...
- Has received prior treatment of any FAK inhibitor or prior treatment of PLD.
- Has a known previous or concurrent cancer that is distinct in primary site or histology from current ovarian cancer within 3 years prior to...
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Note: people with previously treated brain metastases may...
See the full eligibility criteria
Who can join
- Ability to understand and willingness to sign informed consent(s). Signed informed consent must be obtained before any study specific procedures, except those procedures used as institutional standard of care falling...
- Female people ≥ 18 years at the time of signing informed consent.
- Histologically confirmed epithelial ovarian cancer, fallopian tube cancer or primary peritoneum cancer and its subtype is high-grade serous carcinoma (HGSC).
- Have received platinum containing therapy and have radiological relapse or progression during platinum containing treatment or \< 6 months (184 calendar days) after completion of prior platinum-based therapy (at least 4...
- Maximum total of 3 prior lines of systemic therapy are allowed. Note: Hormonal therapies (e.g., tamoxifen), PARP inhibitors and bevacizumab given in the maintenance setting post response to platinum-based therapy will...
- At least one measurable lesion can be accurately measured per RECIST 1.1 as assessed by investigator. Note: Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated...
- ECOG performance status of 0 or 1.
- Life expectancy of at least 3 months as assessed by investigator.
- Availability of archival or fresh (newly obtained) tumor tissue sample during screening phase: fresh tumor tissue sample obtained after most recent relapse or progression is preferred; if no sample or not sufficient...
- Must have recovered from all AEs due to previous therapies to ≤ Grade 1 (CTCAE 5.0) or stable status as assessed by investigator. Note: people with minor toxicities with no safety concern like alopecia and Grade 2...
- Adequate bone marrow, liver, renal, and coagulation function within 7 days prior to randomization.
- Hemoglobin (Hb) ≥ 100 g/L (10 g/dL), independent of blood infusion, red blood cell transfusion and erythropoietin (EPO) use within 14 days prior to the screening period examination.
- Platelet count ≥ 100 × 109/L, independent of platelet infusion within 14 days prior to the screening period examination.
- Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, independent of colony stimulating factor (CSF) use within 14 days prior to the screening period examination.
- Total bilirubin ≤ upper limit of normal (ULN).
- Alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN for people with documented liver involvement of their disease).
- Serum creatinine ≤ 1.5 × ULN, Estimated Creatinine clearance rate (Clcr) by the Cockcroft-Gault (C-G) equation ≥ 60 mL/min or estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease...
- Urinary protein negative or trace (±); or urinary protein ≥ 1+ but with a urine protein to creatinine ratio (UPCR) in a morning spot urine sample \< 0.5 or a 24-hour urine protein \< 0.5 g/24 h.
- International normalized ratio (INR) ≤ 1.5 and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN. people with stable anticoagulation treatment is allowed.
- A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- Not a woman of childbearing potential (WOCBP) as defined in section 10.4 Appendix 4 of the full protocol. OR
- A WOCBP who agrees to follow the contraceptive guidance in section 10.4 Appendix 4 of the full protocol during the treatment period and through 3 months after the last dose of study treatment.
What rules you out
- Has had major surgery or significant traumatic injury within 28 days prior to randomization, or diagnostic biopsies within 14 days prior to randomization. Note: people with anticipation of the need for major surgery...
- Has received prior systemic anticancer therapy including investigational agents, such as within 14 days or less than 5 half-lives (whichever is shorter) of chemotherapy or targeted therapy, or within 28 days of...
- Has received prior radiotherapy within 14 days prior to randomization. Note: A 7-day washout is permitted for palliative radiation (≤ 14 days of radiotherapy) to non-central nervous system (CNS) disease.
- Has received prior treatment of any FAK inhibitor or prior treatment of PLD.
- Has a known previous or concurrent cancer that is distinct in primary site or histology from current ovarian cancer within 3 years prior to randomization, except for curatively treated cancers such as...
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Note: people with previously treated brain metastases may participate provided they are radiologically stable (i.e., without...
- Has a history of major cardiovascular, cerebrovascular or thromboembolic diseases (e.g., congestive heart failure, acute myocardial infarction, unstable angina, stroke, transient ischemic attack, deep vein thrombosis or...
- QTc interval corrected using Fridericia's formula \> 470 ms (based on QTcF).
- Left ventricular ejection fraction (LVEF) \< 50%.
- New York Heart Association (NYHA) functional classification ≥ Grade 2.
- Clinically significant arrhythmia.
- Uncontrolled hypertension or diabetes.
- Other clinically significant heart diseases.
- Has known pleural effusion, pericardial effusion or ascites accompanied by clinical symptoms or requiring puncture or drainage. people who received drainage within the first 3 months of randomization should be excluded...
- Has malabsorption syndrome or inability to take oral drugs.
- Has clinically significant gastrointestinal abnormalities including uncontrolled gastrointestinal inflammatory lesions (Crohn's disease, or ulcerative colitis in active) or uncontrolled gastrointestinal bleeding.
- Clinical or radiographic evidence of intestinal obstruction, or aetiology of previous recurrent ileus not excluded.
- Currently have interstitial pneumonia (except for radiation pulmonary fibrosis that does not require hormonal therapy).
- Has not well controlled active infection after systemic therapy.
- Has known human immunodeficiency virus (HIV) infection or known active Hepatitis B or Hepatitis C virus infection. Note: No HIV, Hepatitis B and Hepatitis C testing is required unless mandated by local health authority...
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is...
- Has a known psychiatric or substance abuse disorder that would interfere with the subject's ability to cooperate with the requirements of the study.
- Known allergy or hypersensitivity to IN10018 or PLD, or their ingredients.
- Has received prior cumulative anthracycline dose of 550 mg/m2 or more.
- Has received systemic treatment of CYP3A4, CYP2D6 or P-gp strong inhibitors/inducers within 14 days prior to randomization, or anticipation of the systemic treatment of these drugs during Treatment Phase.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, 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 Beijing, 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.