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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 is a Phase 2 study that has completed, run by ImmunityBio. The registered enrollment target is 15 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01580397
The ClinicalTrials.gov registry entry for NCT01580397 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ImmunityBio, which has 46 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which INNO-206 is the first listed.
NCT01580397 reports 0 study locations.
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.
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