Clinically significant ascites, defined as ascites that is symptomatic or has resulted in a paracentesis in the past 3 months
Uncontrolled ascites requiring weekly large-volume paracentesis for 2 consecutive weeks prior to initiation of study treatment
Patients who had therapeutic paracentesis of ascites (> 1L) within the 3 months prior to starting study treatment or who, in the opinion of the investigator, will likely need therapeutic paracentesis of ascites (> 1L) within 3 months of starting study treatment.
Refractory encephalopathy or ascites
Fluctuating ascites
Ascites that your doctor will manage by increasing your medications or by performing non-invasive methods (eg, paracentesis) to control, within 6 months prior to the first scheduled dose.
Clinical evidence of ascites (trace ascites on imaging acceptable)
No evidence of clinically apparent ascites or active encephalopathy, and/or varices that have not been treated; subjects with controlled ascites or encephalopathy are eligible so long as they meet Childs-Pugh score criterion; please note that controlled ascites and encephalopathy require scores of 2 each when calculating the C-P score
Clinical ascites or metastatic pleural fluid
Ascites refractory to medical therapy (mild to moderate ascites is allowed)
No clinical evident ascites that required therapeutic paracentesis
Malignant ascites that is clinically detectable by physical examination or is symptomatic; evidence of radiographic ascites that is not clinically significant will not be an exclusion criterion
Clinically apparent ascites on physical examination, ascites present on imaging studies is allowed
Presence of symptomatic liver failure including ascites and hepatic encephalopathy
Requirement for diuretics, paracentesis, or other medications or procedures to control ascites or hepatic encephalopathy within 6 months before enrollment\r\n* Diuretics or medications such as lactulose used for other indications (e.g. edema, constipation) are allowed
Decompensated liver disease as evidenced by clinically significant ascites refractory to diuretic therapy, hepatic encephalopathy, or coagulopathy
Moderate or severe ascites
Has clinically relevant ascites at baseline (defined as requiring paracentesis) or with moderate radiographic ascites; a minimal amount of radiographic ascites is allowed
Participants with uncontrolled gross ascites or encephalopathy; assessment of ascites will be determined by the treating physician
Patients with any clinically apparent ascites or who have undergone a paracentesis within 7 days of enrollment
Evidence of severe portal hypertension with evidence of decompensation either with bleeding varices, large volume ascites, or hepatic encephalopathy
If present, clinically significant or symptomatic amounts of ascites should be drained prior to Day 1.
Clinical ascites
Patients with malignant small bowel obstruction within the last 6 months, on parenteral nutrition, clinically significant ascites (palpable on physical exam and/or causing symptoms) or ascites requiring fluid removal more than twice in the last 6 weeks
Subjects with clinically apparent ascites or encephalopathy, or untreated varices are not eligible for enrollment
Moderate to large volume ascites.
Significant ascites that require therapeutic paracentesis
At risk for hepatic or renal failure\r\n* Serum creatinine > 1.5 mg/dl\r\n* Serum bilirubin > 1.3 mg/ml\r\n* Albumin < 2.0 g/dL\r\n* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 times upper normal limit\r\n* Any history of hepatic encephalopathy\r\n* Cirrhosis or portal hypertension\r\n* Clinically evident ascites (trace ascites on imaging is acceptable)
Presence of ascites (as determined by clinician)
Ascites refractory to medical therapy
Ascites refractory to medical therapy
Any evidence of ascites (beyond trace)
No clinical evidence of hepatic failure (e.g. coagulopathy, ascites)
Patients with current cirrhotic status of Child-Pugh class A only (5-6 points with total bilirubin < 2 mg/dL for dose-escalation) with no encephalopathy and no clinical ascites (ascites controlled by diuretics is also excluded in this study).
Evidence of significant ascites as determined by the investigator
Hepatic blood flow abnormalities and/or large-volume ascites
Presence of ascites that is not medically controlled or that required a therapeutic paracentesis within the last 3 months prior to initiation of study therapy
Patients must be willing and able to undergo ascites fluid collection pre- and post-study treatment if adequate ascites is present; patients without adequate ascites may also participate in the trial
Has clinically apparent ascites on physical examination. Note: ascites detectable on imaging studies only ARE allowed.
Moderate or severe ascites.
Clinically evident ascites (trace ascites on imaging is acceptable)
Any prior (within 1 year) or current clinically significant ascites as measured by physical examination and that requires paracentesis for control;
Clinically significant ascites
Decompensated liver disease as evidenced by clinically significant ascites refractory to diuretic therapy, hepatic encephalopathy, or coagulopathy
Have greater than grade 2 ascites at time of enrollment.
Have presence of clinically relevant ascites.
Any prior or current clinically significant ascites
Significant or symptomatic amount of ascites should be drained prior to first dose of BBI608.
Clinically evident ascites (trace ascites on imaging is acceptable)
Has clinically apparent ascites on physical examination
No clinical ascites (mild ascites on scans permissible)
Ascites requiring intervention
Subject has uncontrolled symptomatic ascites.
Uncontrolled or clinically relevant ascites
Histologically confirmed metastatic ovarian or GI malignancy with malignant ascites amenable for paracentesis; adjudication of malignant ascites can be made on clinical grounds e.g. in the absence of cirrhosis or other non-malignant causes of ascites
Presence of clinically significant ascites
Decompensated liver disease as evidenced by clinically significant ascites refractory to diuretic therapy, hepatic encephalopathy, or coagulopathy
Moderate or severe ascites
No moderate-to-severe ascites (subjects with ascites restricted to the perihepatic space or pelvic cavity)
Clinical ascites
Clinically evident ascites (trace ascites on imaging is acceptable)
Uncontrolled ascites defined as not easily controlled by stable doses of diuretics
Uncontrolled ascites (defined as not easily controlled with diuretic or paracentesis treatment).
Ascites detected by CT, ultrasound (US) or MRI; (trace ascites will not be an exclusion)
Presence of symptomatic liver failure including ascites and hepatic encephalopathy
Patients cannot have active ascites
Subjects with refractory ascites, defined as ascites needing drainage catheter or therapeutic paracentesis more often than every 4 weeks
Recurrent symptomatic malignant ascites having required at least 2 paracenteses within a 45-day interval prior to baseline paracentesis
Compensated cirrhosis defined as a Child-Pugh score of 5 or 6 at Screening • A minimal rim of ascites if detected at imaging is acceptable. Exclude ascites that requires the need to apply diuretic treatment to control ascites
Significant or symptomatic amounts of ascites should be drained prior to Cycle 1 Day
Clinically significant ascites or clinical evidence or history of portosystemic hypertension or cirrhosis.
No signs of decompensated liver cirrhosis or ascites requiring therapeutic paracentesis
Uncontrolled ascites requiring weekly large volume paracentesis for 3 consecutive weeks prior to enrollment
Poorly controlled ascites and/or requirement for therapeutic paracentesis more frequently than once every 3 months.
Clinically significant ascites
Unwilling to allow removal of tumor biological samples for analysis, i.e., biopsies of tumor lesions, and/or collection of ascites fluid from abdominal ascites (if present)
Presence of ascites that requires paracentesis more frequently than once every 21 days.
Presence of ascites that preclude biopsy of liver lesions.
Subjects with sensory neuropathy, ascites, or plastic biliary stent.
Subjects with clinically significant ascites
Clinically evident ascites
Active infection, ascites, hepatic encephalopathy
Evidence of ascites on imaging study, or the use of diuretics for ascites
Patients with clinically significant ascites requiring paracentesis on 2 or more occasions within 4 weeks prior to start of study treatment
Significant peri-hepatic ascites interfering with safe/effective PTBD.
Patients presenting with ascites
Presence of ascites
Moderate or severe ascites
History of or current hepatic encephalopathy or clinically meaningful ascites.
Ascites absent
Uncontrolled large ascites
Clinically or radiographically detectable ascites (beyond trace/rim of ascites) or ascites requiring medication
Minimal or non-symptomatic ascites
Ascites or other clinical or radiographical signs of portal hypertension
Uncontrolled ascites that is not stable with medical management (i.e., on diuretics and salt restriction) as defined by requiring therapeutic paracentesis more than once every 4 weeks.
Uncontrolled ascites requiring weekly large volume paracentesis for 3 consecutive weeks prior to enrollment