Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
GenSpera, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Informed consent document signed prior to the performance of any study-specific procedures and initiation of study therapy
At least 18 years of age
ECOG Performance Status 0 or 1
Histologic or cytologic confirmation of hepatocellular carcinoma (HCC)
Child-Pugh score of A or B7
At least one measurable lesion (preferably in the liver) assessed within 4 weeks of first administration of G-202 by abdominal CT or MRI with dynamic phase imaging of the liver, pelvic CT or MRI with contrast, chest CT with contrast, and bone imaging in patients with known bone metastases or if medically indicated
Must have received sorafenib therapy and had disease progression on sorafenib therapy or was not able to tolerate sorafenib
Sorafenib or other anti-cancer therapy must have been discontinued \> 21days prior to the first administration of G-202
Acute toxicity from previous therapy (excluding alopecia) must have resolved to ≤ Grade 1 per CTCAE v4.0
Negative serum pregnancy test for women of child-bearing potential
You may not be if
Prior locoregional therapies (e.g., transarterial chemoembolization \[TACE\]) ≤ 4 weeks prior to the first administration of G-202 or not recovered from treatment-related toxicities.
Radiotherapy ≤ 4 weeks prior to the first administration of G-202 or not recovered from toxicities (palliative radiotherapy for bone lesions ≤ 2 weeks prior allowed)
Major surgery ≤ 4 weeks prior to first administration of G-202
Intolerance to both CT and MRI contrast agents
Candidate for liver transplantation
Persistent or untreated biliary infection
Any GI bleeding within 12 weeks prior to first administration of G-202
Currently receiving any full-dose anti-coagulation treatment
Clinically-significant third space fluid accumulation
Known CNS metastasis, including brain metastasis or leptomeningeal metastasis
Known human immunodeficiency virus (HIV) positivity
Viral hepatitis requiring anti-viral therapy
History or evidence of cardiac risk, including screening QTc interval \> 470 msec, clinically-significant uncontrolled arrhythmias or arrhythmia requiring treatment (except atrial fibrillation and paroxysmal supraventricular tachycardia), history of acute coronary syndromes within 6 months (including myocardial infarction and unstable angina, coronary artery bypass graft, angioplasty, or stenting) or history of congestive heart failure with most recent ejection fraction \< 45%
Uncontrolled hypertension (systolic BP ≥ 160 or diastolic BP ≥ 100)
Cerebrovascular accident or transient ischemic attack within 6 months prior to the first dose of study therapy
History of pulmonary embolism within 6 months or untreated deep venous thrombosis
Documentation of keratosis follicularis (also known as Darier or Darier-White disease)
Requirement for chronic use of inhibitors or inducers of cytochrome (CYP3A4) iso-enzymes
Known hypersensitivity to any study drug component, including thapsigargin derivatives, polysorbate 20, or propylene glycol
Known history of another primary malignancy that has not been in remission for at least 2 years (non-melanoma skin cancer, cervical carcinoma in situ or squamous intraepithelial lesions allowed)
Use of any investigational agent within 4 weeks prior to the first administration of G-202
Pregnancy or nursing
Any medical intervention, other medical condition, psychiatric condition or social circumstance which could compromise patient safety and/or adherence with study requirements
