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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 is a Phase 1 study that was terminated before completion, run by Precision Biologics. The registered enrollment target is 81 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01834235
The ClinicalTrials.gov registry entry for NCT01834235 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 81 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Precision Biologics, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Gemcitabine is the first listed.
NCT01834235 reports 0 study locations.
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.
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