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NCT01334710 · ClinicalTrials.gov registry record · Phase 2
A Phase II Trial of OSI-906 and Sorafenib in Advanced Hepatocellular Cancer
A Phase 2 study, sponsored by Emory University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT01334710: Clinical Trial Phase 2 study, sponsored by Emory University.
NCT01334710 is a Phase 2 study that was terminated before completion, run by Emory University. The registered enrollment target is 3 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01334710, a Phase 2 study, was terminated before completion, sponsored by Emory University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the effect of combining a new investigational drug (OSI-906) with a standard drug (sorafenib) on the control of liver cancer (hepatocellular cancer). Sorafenib (brand name Nexavar®) is a drug that is approved for the treatment of advanced liver cancer. It works by stopping the growth of new blood vessels around the tumor. OSI-906 is an investigational agent that works by inhibiting the effects of a growth hormone on the cancer. The safety and efficacy of combining OSI-906 and sorafenib in the treatment of liver cancer risk not known. The current study will confirm the safety of the combination in the first six patients and evaluate the activity of the combination in patients with advanced liver cancer. In addition, the study will aim at collecting blood samples from patients to evaluate the level of OSI-906 in patients receiving the combination of the two drugs. The study also will collect samples of the tumor to evaluate for markers that can predict in which patient the combination is effective.
Primary Outcome
Efficacy will be measured by evaluating the number of patients who do not have disease progression (measured by CT or MRI scan) 5 months after starting treatment. Assessment of the endpoint of disease progression will be performed every 2 months using either CT or MRI scan. Participants will remain on the study until either evidence of disease progression or unacceptable side effects develop. This period is expected to be on the average 6 months long.
Interventions
- DRUG Sorafenib and OSI-906
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2011-03 |
| Est. Completion | 2011-12 |
| Phase | Phase 2 |
Why NCT01334710 stopped before completion
NCT01334710 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Sorafenib and OSI-906 is the first listed.
NCT01334710 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01334710 about?
NCT01334710 is a clinical study titled "A Phase II Trial of OSI-906 and Sorafenib in Advanced Hepatocellular Cancer". The purpose of this study is to evaluate the effect of combining a new investigational drug (OSI-906) with a standard drug (sorafenib) on the control of liver cancer (hepatocellular cancer). Sorafenib (brand name Nexavar®) is a drug that is approved for the treatment of advanced liver cancer. It wor...
What is the current status of trial NCT01334710?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2011-03. Estimated completion is 2011-12.
What interventions are being tested in trial NCT01334710?
The interventions under investigation include: Sorafenib and OSI-906 (DRUG).
Who is sponsoring clinical trial NCT01334710?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01334710's enrollment target sits among peer trials
3 2001st of 2000 the lowest 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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