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NCT01580397 · ClinicalTrials.gov registry record · Phase 2
Pilot Phase 2 Study to Investigate the Preliminary Efficacy and Safety of INNO-206 in Advanced Pancreatic Cancer
A Phase 2 study, sponsored by ImmunityBio.
- Completed
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
NCT01580397: Completed Phase 2 study, sponsored by ImmunityBio.
NCT01580397 is a Phase 2 study that has completed, run by ImmunityBio. The registered enrollment target is 15 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01580397, a Phase 2 study, has completed, sponsored by ImmunityBio.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
Study Summary
Patients with metastatic, locally advanced, or unresectable pancreatic ductal carcinomas (PDA) who have failed prior chemotherapy with gemcitabine regimens have an extremely poor prognosis with progression-free survival of around 13 weeks and median overall survival of approximately 20 weeks after second line chemotherapy. Recent studies suggest that albumin may be preferentially concentrated in pancreatic cancers that appear to be starved for this protein. Thus, any molecule attached to albumin would also collect inside the tumor. Based on its postulated mechanism of action, INNO-206 may improve the activity of doxorubicin without increasing its toxicity, as has been demonstrated in animal studies, and induce enhanced anti-tumor efficacy.
Primary Outcome
Objective responses were evaluated using the Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1). Changes (ie, improvements) in tumor measurements from baseline values were assigned a status of CR or PR or SD. Objective response measurements comprised the sum of CR plus PR. Complete Response (CR): disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm). Partial Response (PR): \>=30% decrease in the
Interventions
- DRUG INNO-206
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2012-05-16 |
| Est. Completion | 2013-07-02 |
| Phase | Phase 2 |
What the finished NCT01580397 record still lists
NCT01580397 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 1 intervention - of which INNO-206 is the first listed.
NCT01580397 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01580397 about?
NCT01580397 is a clinical study titled "Pilot Phase 2 Study to Investigate the Preliminary Efficacy and Safety of INNO-206 in Advanced Pancreatic Cancer". Patients with metastatic, locally advanced, or unresectable pancreatic ductal carcinomas (PDA) who have failed prior chemotherapy with gemcitabine regimens have an extremely poor prognosis with progression-free survival of around 13 weeks and median overall survival of approximately 20 weeks after s...
What is the current status of trial NCT01580397?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2012-05-16. Estimated completion is 2013-07-02.
What interventions are being tested in trial NCT01580397?
The interventions under investigation include: INNO-206 (DRUG).
Who is sponsoring clinical trial NCT01580397?
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 NCT01580397's enrollment target sits among peer trials
15 1919th of 2000 higher than 60 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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