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NCT01514188 · ClinicalTrials.gov registry record · Phase 2
Preliminary Efficacy and Safety of INNO-206 Compared to Doxorubicin in Advanced Soft Tissue Sarcoma
A Phase 2 study, sponsored by ImmunityBio.
- Completed
- Registry status
- Phase 2
- Development phase
- 126
- Enrollment target
NCT01514188: Completed Phase 2 study, sponsored by ImmunityBio.
NCT01514188 is a Phase 2 study that has completed, run by ImmunityBio. The registered enrollment target is 126 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01514188, a Phase 2 study, has completed, sponsored by ImmunityBio.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 126 participants
- Enrollment target
Study Summary
This is a phase 2b, randomized, open-label, prospective, multicenter study comparing treatment with INNO 206 to doxorubicin in subjects with metastatic, locally advanced, or unresectable soft tissue sarcomas who have not been previously treated with any chemotherapy except potentially as adjuvant or neoadjuvant chemotherapy, and no evidence of tumor recurrence has occurred for at least 12 months.
Primary Outcome
Progression-free survival is defined as the interval from the date of registration (ie, assignment of subject number) to the earliest date of documented evidence of recurrent or progressive disease, or the date of death due to any cause, whichever occurs first. Progressive Disease is defined as: 20% increase in the sum of the longest diameter of target lesions from the smallest sum of the longest diameter recorded since the treatment started; the sum must also demonstrate an absolute increase o
Interventions
- DRUG Doxorubicin
- DRUG INNO-206
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 126 participants |
| Start Date | 2012-01-11 |
| Est. Completion | 2014-12-15 |
| Phase | Phase 2 |
What the finished NCT01514188 record still lists
NCT01514188 is an interventional study that assigns participants to a tested intervention. The registered 126 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Doxorubicin is the first listed.
NCT01514188 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01514188 about?
NCT01514188 is a clinical study titled "Preliminary Efficacy and Safety of INNO-206 Compared to Doxorubicin in Advanced Soft Tissue Sarcoma". This is a phase 2b, randomized, open-label, prospective, multicenter study comparing treatment with INNO 206 to doxorubicin in subjects with metastatic, locally advanced, or unresectable soft tissue sarcomas who have not been previously treated with any chemotherapy except potentially as adjuvant or...
What is the current status of trial NCT01514188?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 126 participants. The study started on 2012-01-11. Estimated completion is 2014-12-15.
What interventions are being tested in trial NCT01514188?
The interventions under investigation include: Doxorubicin (DRUG), INNO-206 (DRUG).
Who is sponsoring clinical trial NCT01514188?
This trial is sponsored by ImmunityBio, which has 46 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01514188's enrollment target sits among peer trials
126 556th of 2000 higher than 1,443 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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