Clinical trial: A Study of Syngenon (BSG-001) for Inhalation in Subjects With Malignant Pleural Effusion and/or Malignant Ascites (NCT03736122)

Eligibility criteria:
Inclusion Criteria:

          1. Histologically or cytologically documented malignant pleural effusion and/or malignant
             ascites OR morphological diagnosis of malignant pleural effusion and/or malignant
             ascites by CT or ultrasound

          2. Histologically confirmed cancer

          3. Malignant pleural effusion and/or malignant ascites clinically judged as not
             responsive to conventional systemic therapy(ies) for primary malignancy

          4. Adequate liver and renal function as defined below:

          5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

          6. Life expectancy of > 12 weeks

          7. Willing and able to provide written, signed informed consent after the nature of the
             study has been explained, and prior to any research-related procedures

          8. Females of childbearing potential must have a negative serum pregnancy test at
             screening and be willing to have additional serum pregnancy tests during the study.

          9. Willing and able to comply with all study procedures

        Exclusion Criteria:

          1. Presence of > grade 3 active infection or gastric bleeding at the time of screening

          2. Change in chemotherapy regimen within 28 days before Day 1 of study drug
             administration

          3. Concurrent use of any investigational product (IP) or investigational medicine within
             28 days before Day 1 of study drug administration

          4. Symptomatic interstitial lung disease or inflammatory pneumonitis

          5. Concurrent disease or condition which, in the opinion of the Investigator, would pose
             a risk to patient safety or interfere with study participation or interpretation of
             individual patient results

          6. Breastfeeding at screening or planning to become pregnant (self or partner) at any
             time during study participation
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.


Patient description (medical language): A 61-year-old man comes to the clinic due to nonproductive cough and progressive dyspnea.  The patient's medical conditions include hypertension, hypercholesteremia and peptic ulcer disease.  He smokes 2 packs of cigarettes daily for the past 30 years.  On examination, there are decreased breath sounds and percussive dullness at the base of the left lung.  Other vital signs are normal. Abdomen is soft without tenderness. CT scan shows a left-sided pleural effusion and nodular thickening of the pleura. The plural fluid was bloody on thoracentesis. Biopsy shows proliferation of epithelioid-type cells with very long microvilli.

Patient description (patient's own words): I am 61 and I had to go to the clinic because I couldn't stop coughing and I experienced some breath shortness. I suffer from hypertension and cholesterol and I also have a stomach ulcer. I should admit that I've been smoking 2 packs of cigarettes every day for the past 30 years. My doctor told me that my breath in my left lung sounds bad. But he told me that my blood pressure, heart rate, breathing rate and temperature are normal. My belly is also normal. However my X-Rays show some liquid on the left side and a mass where the liquid got hard. The scary thing is that the liquid was bloody when they got it out. They did a biopsy and it showed that I have an increase of epithelioid-type cells with very long microvilli.

Does the patient match the trial criteria? Entailment