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Completed Phase 2 Interventional

Study of G-202 (Mipsagargin) as Second-Line Therapy Following Sorafenib in Hepatocellular Carcinoma

ClinicalTrials.gov ID: NCT01777594

Public ClinicalTrials.gov record NCT01777594. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 7, 2026, 10:24 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Hepatocellular carcinoma (HCC) is the fifth most common type of cancer worldwide and the third most common cause of death from cancer. Sorafenib is the only approved therapy for treatment of advanced HCC, and there is a need to identify more drugs that are beneficial for these patients without unacceptable side effects. Prodrug chemotherapy is an approach in which an inactive non-toxic agent is administered to the patient and gets activated within the body at specific locations, resulting in a higher concentration of the cytotoxic form at a tumor location while avoiding general side effects. G-202 (mipsagargin) is an example of prodrug chemotherapy. It is activated by Prostate Specific Memory Antigen (PSMA), which is expressed by some cancer cells and in the blood vessels of most solid tumors, but not by normal cells or blood vessels in normal tissue. It is believed that activation of the prodrug G-202 will allow the drug to kill cancer cells. This study will evaluate the activity and safety of G-202 in patients with hepatocellular carcinoma who have progressed after taking sorafenib. The study will evaluate clinical activity and safety of G-202 administered by intravenous infusion on three consecutive days of a 28-day cycle.

Study identification

NCT ID
NCT01777594
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
GenSpera, Inc.
Industry
Enrollment
25 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 31, 2012
Primary completion
Feb 28, 2015
Completion
Feb 28, 2015
Last update posted
Aug 22, 2016

2013 – 2015

United States locations

U.S. sites
4
U.S. states
1
U.S. cities
3
Facility City State ZIP Site status
Mary Crowley Cancer Research Center Dallas Texas 75230
Oncology Consultants, PA Houston Texas 77030
University of Texas Health Sciences Center at Houston, Memorial Hermann Cancer Center Houston Texas 77030
The University of Texas Health Science Center at San Antonio San Antonio Texas 78229-3900

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01777594, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 22, 2016 · Synced Sep 7, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01777594 live on ClinicalTrials.gov.

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