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NCT01834235 · ClinicalTrials.gov registry record · Phase 1
QUILT-3.010: A Study of Gemcitabine and Nab-paclitaxel With or Without NPC-1C to Treat Patients With Pancreatic Cancer
A Phase 1 study, sponsored by Precision Biologics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 81
- Enrollment target
NCT01834235: Clinical Trial Phase 1 study, sponsored by Precision Biologics.
NCT01834235 is a Phase 1 study that was terminated before completion, run by Precision Biologics. The registered enrollment target is 81 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01834235, a Phase 1 study, was terminated before completion, sponsored by Precision Biologics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 81 participants
- Enrollment target
Study Summary
This was a Phase 1/2 multi-institution prospective open label study in which subjects with metastatic, locally advanced unresectable or recurrent pancreatic cancer who previously received treatment with chemotherapy with FOLFIRINOX or FOLFIRINOX-like regimen received the investigational agent NEO-102 (NPC-1C). The Phase 1 portion of this study evaluated the safety of NEO-102 in combination with Gemcitabine in a dose de-escalation design with a starting dose of 1.5 mg/kg/dose. If 2 of 6 patients experience DLT, the dose will be de-escalated to 1 mg/kg/dose to evaluate the safety of NEO-102 in combination with Gemcitabine. . In the Phase 2 portion patients were randomized into one of two arms: A: NPC-1C with gemcitabine and nab-paclitaxel or B: gemcitabine and nab-paclitaxel
Primary Outcome
To determine the safety and tolerability of NPC-1C monoclonal antibody therapy in combination with Gemcitabine in subjects with metastatic, locally advanced unresectable or recurrent pancreatic cancer who failed or did not tolerate first line chemotherapy of FOLFIRINOX and whose tumors bind NPC-1C.
Interventions
- DRUG Gemcitabine
- DRUG nab-paclitaxel
- DRUG NPC-1C
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2013-04 |
| Est. Completion | 2019-12 |
| Phase | Phase 1 |
Why NCT01834235 stopped before completion
NCT01834235 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% higher).
The record links to 0 conditions, and to 3 interventions - of which Gemcitabine is the first listed.
NCT01834235 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01834235 about?
NCT01834235 is a clinical study titled "QUILT-3.010: A Study of Gemcitabine and Nab-paclitaxel With or Without NPC-1C to Treat Patients With Pancreatic Cancer". This was a Phase 1/2 multi-institution prospective open label study in which subjects with metastatic, locally advanced unresectable or recurrent pancreatic cancer who previously received treatment with chemotherapy with FOLFIRINOX or FOLFIRINOX-like regimen received the investigational agent NEO-10...
What is the current status of trial NCT01834235?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 81 participants. The study started on 2013-04. Estimated completion is 2019-12.
What interventions are being tested in trial NCT01834235?
The interventions under investigation include: Gemcitabine (DRUG), nab-paclitaxel (DRUG), NPC-1C (DRUG).
Who is sponsoring clinical trial NCT01834235?
This trial is sponsored by Precision Biologics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01834235's enrollment target sits among peer trials
81 671st of 2000 higher than 1,329 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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