Study of G-202 (Mipsagargin) as Second-Line Therapy Following Sorafenib in Hepatocellular Carcinoma (G-202-003)
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ClinicalTrials.gov Identifier: NCT01777594 |
Recruitment Status :
Completed
First Posted : January 29, 2013
Last Update Posted : August 23, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Advanced Adult Hepatocellular Carcinoma | Drug: G-202 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 25 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II, Multicenter, Single-Arm Study of G-202 (Mipsagargin) as Second-Line Therapy Following Sorafenib for Adult Patients With Progressive Advanced Hepatocellular Carcinoma |
Study Start Date : | January 2013 |
Actual Primary Completion Date : | March 2015 |
Actual Study Completion Date : | March 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: G-202 (Mipsagargin)
G-202 (mipsagargin) administered by intravenous infusion on 3 consecutive days of a 28-day cycle
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Drug: G-202
G-202 administered by intravenous infusion (IV, in the vein) on Days 1, 2 and 3 of each 28-day cycle until progression or development of unacceptable toxicity
Other Name: Mipsagargin |
- Time to progression [ Time Frame: every 8 weeks, until disease progression (estimated up to 2 years) ]Duration of time from the first administration of G-202 to the time of radiologic progression
- Overall response rate [ Time Frame: every 8 weeks, until disease progression (estimated up to 2 years) ]Percentage of patients with complete response (CR), partial response (PR) or stable disease (SD) after treatment with G-202
- Progression-free survival [ Time Frame: every 8-12 weeks, until disease progression or death (estimated up to 3 years) ]Duration of time from the first administration of G-202 to the time of radiologic progression or death
- Overall survival [ Time Frame: every 12 weeks for approximately 3 years or until patient death ]Duration of time from the first administration of G-202 to the time of death

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01777594
United States, Texas | |
Mary Crowley Cancer Research Center | |
Dallas, Texas, United States, 75230 | |
Oncology Consultants, PA | |
Houston, Texas, United States, 77030 | |
University of Texas Health Sciences Center at Houston, Memorial Hermann Cancer Center | |
Houston, Texas, United States, 77030 | |
The University of Texas Health Science Center at San Antonio | |
San Antonio, Texas, United States, 78229-3900 |
Study Chair: | Devalingam Mahalingam, M.D., Ph.D. | University of Texas, Health Science Center, Cancer Therapy and Research Center |
Responsible Party: | GenSpera, Inc. |
ClinicalTrials.gov Identifier: | NCT01777594 |
Other Study ID Numbers: |
G-202-003 |
First Posted: | January 29, 2013 Key Record Dates |
Last Update Posted: | August 23, 2016 |
Last Verified: | August 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
hepatocellular carcinoma HCC liver liver cancer sorafenib |
Carcinoma Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma |
Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases |