Phase
Condition
Ovarian Cysts
Treatment
PLD
APG -2449
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Part A: No gender limitation. Patients with histologically and/or cytologicallyconfirmed ALK/ROS1 gene fusion positive non-small cell lung cancer and variousadvanced tumors. Part B: Female only. Histologically proven ovarian epithelial, fallopian tube, orprimary peritoneal carcinoma.
At least one measurable tumor lesion.
ECOG score is 0~1.
Life expectancy of ≥3 months.
AE caused by previous treatment must recover to ≤ grade 1.
Sufficient bone marrow, liver, kidney and coagulation function.
Female patients must be in a non-pregnant and non-lactating state.
Able to understand and willing to sign informed consent.
Patients are required to provide fresh or archived tumor tissue samples prior totreatment.
Exclusion
Exclusion Criteria:
Undergone major surgery or major trauma within 28 days before first dose or adiagnostic biopsy within 14 days before first dose.
Received systemic antitumor drugs, including investigational drugs.
Received radiotherapy within 14 days before first dose.
Previous treatment with FAK inhibitors.
Have tumors at positions other than existing ovarian cancer or of other histologicaltypes within 3 years before first dose.
Known active central nervous system (CNS) metastases and/or cancerous meningitis.
Major cardiovascular and cerebrovascular disease occurred within 6 months beforefirst dose.
Patients with pleural effusion, pericardial effusion, or ascites requiring puncture,drainage, or having received drainage within 1 month before first dose.
Malabsorption syndrome, or inability to take medications orally.
Severe gastrointestinal disease.
Any serious or uncontrolled systemic disease; Various chronic active infections.
Allergy to APG-2449 or PLD and its drug components.
Previous cumulative doses of anthracyclines ≥550 mg/m^2.
Patients using a moderately potent CYP3A4, CYP2C9, or CYP2C19 inhibitor/inducer orP-gp inhibitor within a week before first dose. Patients using CYP3A4 substrates andthe drugs of a narrow treatment window within a week before first dose.
Other factors that, in the investigator's judgment, should prevent the patient fromentering the study.
Study Design
Study Description
Connect with a study center
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong 510060
ChinaActive - Recruiting

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.