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A Phase II, Multicenter, Single-Arm Study of G-202 as Second-Line Therapy Following Sorafenib for Adult Patients With Progressive Advanced Hepatocellular Carcinoma

Phase 2
18 Years
Open (Enrolling)
Advanced Adult Hepatocellular Carcinoma

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Trial Information

A Phase II, Multicenter, Single-Arm Study of G-202 as Second-Line Therapy Following Sorafenib for Adult Patients With Progressive Advanced Hepatocellular Carcinoma

Inclusion Criteria:

- 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

- Adequate hematologic function (ANC ≥ 1200/mm3, hemoglobin ≥ 8.5 g/dL, platelet count
≥ 75,000/mm3)

- Adequate hepatic function (albumin ≥ 2.8 g/dL, AST and ALT ≤ 5 x ULN, total bilirubin
< 2 mg/dL)

- Adequate renal function (proteinuria level ≤ 2+, serum creatinine ≤ 1.5 x ULN)

- Acceptable coagulation profile (PT/INR ≤ 2.3, aPTT ≤ 1.5 x ULN)

- 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

Exclusion Criteria:

- Prior locoregional therapies (e.g., transarterial chemoembolization [TACE]) ≤ 4 weeks
prior to the first administration of G-202 or not recovered from treatment-related

- 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

- Requirement for chronic use of inhibitors or inducers of cytochrome (CYP3A4)

- 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

- Pregnancy or nursing

- Any medical intervention, other medical condition, psychiatric condition or social
circumstance which could compromise patient safety and/or adherence with study

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to progression

Outcome Description:

Duration of time from the first administration of G-202 to the time of radiologic progression

Outcome Time Frame:

every 8 weeks, until disease progression (estimated up to 2 years)

Safety Issue:


Principal Investigator

Devalingam Mahalingam, M.D., Ph.D.

Investigator Role:

Study Chair

Investigator Affiliation:

University of Texas, Health Science Center, Cancer Therapy and Research Center


United States: Food and Drug Administration

Study ID:




Start Date:

January 2013

Completion Date:

January 2015

Related Keywords:

  • Advanced Adult Hepatocellular Carcinoma
  • hepatocellular carcinoma
  • HCC
  • liver
  • liver cancer
  • sorafenib
  • Carcinoma
  • Carcinoma, Hepatocellular



The University of Texas Health Science Center at San AntonioSan Antonio, Texas  78229
Oncology Consultants, PAHouston, Texas  77024
Mary Crowley Cancer Research CenterDallas, Texas  75246