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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: Completed Phase 2 study, sponsored by GenSpera.
NCT01777594 is a Phase 2 study that has completed, run by GenSpera. The registered enrollment target is 25 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Duration of time from the first administration of G-202 to the time of radiologic progression
Interventions
- DRUG G-202
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2013-01 |
| Est. Completion | 2015-03 |
| Phase | Phase 2 |
What the finished NCT01777594 record still lists
NCT01777594 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 1 intervention - of which G-202 is the first listed.
NCT01777594 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01777594's enrollment target sits among peer trials
25 1719th of 2000 higher than 245 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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