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NCT01777594 · ClinicalTrials.gov registry record · Phase 2
Study of G-202 (Mipsagargin) as Second-Line Therapy Following Sorafenib in Hepatocellular Carcinoma
A Phase 2 study, sponsored by GenSpera.
- Completed
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
NCT01777594 is a Phase 2 study that has completed, run by GenSpera. The registered enrollment target is 25 participants.
The verdict
NCT01777594, a Phase 2 study, has completed, sponsored by GenSpera.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG G-202
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2013-01 |
| Est. Completion | 2015-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01777594
The ClinicalTrials.gov registry entry for NCT01777594 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GenSpera, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which G-202 is the first listed.
NCT01777594 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01777594 about?
NCT01777594 is a clinical study titled "Study of G-202 (Mipsagargin) as Second-Line Therapy Following Sorafenib in Hepatocellular Carcinoma". 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 unacc...
What is the current status of trial NCT01777594?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2013-01. Estimated completion is 2015-03.
What interventions are being tested in trial NCT01777594?
The interventions under investigation include: G-202 (DRUG).
Who is sponsoring clinical trial NCT01777594?
This trial is sponsored by GenSpera, which has 5 total clinical trials registered on ClinicalTrials.gov.
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