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NCT01318642 · ClinicalTrials.gov registry record · Phase 2
Ganitumab in Locally Advanced Unresectable Adenocarcinoma of the Pancreas
A Phase 2 study, sponsored by NantBioScience.
- Terminated
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT01318642 is a Phase 2 study that was terminated before completion, run by NantBioScience. The registered enrollment target is 10 participants.
The verdict
NCT01318642, a Phase 2 study, was terminated before completion, sponsored by NantBioScience.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study Summary
This study is a phase 2, multicenter, randomized, double-blind, active placebo-controlled trial of AMG 479 or placebo in combination with gemcitabine as first-line therapy for locally advanced unresectable adenocarinoma of the pancreas. Approximately 150 subjects will be randomized in a 1:1 ratio to AMG 479 and gemcitabine, or gemcitabine and placebo. Randomization will be stratified by ECOG (0 or 1). Gemcitabine will be given on days 1, 8, and 15, followed by AMG 479 on days 1 and 15 of every 28 day cycle. Treatment will continue until radiographic disease progression, unacceptable toxicity, withdrawal of consent, or start of a new anti-cancer therapy.
Interventions
- DRUG Placebo
- DRUG Gemcitabine
- DRUG AMG 479
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2012-05-31 |
| Est. Completion | 2012-12-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01318642
The ClinicalTrials.gov registry entry for NCT01318642 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NantBioScience, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01318642 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01318642 about?
NCT01318642 is a clinical study titled "Ganitumab in Locally Advanced Unresectable Adenocarcinoma of the Pancreas". This study is a phase 2, multicenter, randomized, double-blind, active placebo-controlled trial of AMG 479 or placebo in combination with gemcitabine as first-line therapy for locally advanced unresectable adenocarinoma of the pancreas. Approximately 150 subjects will be randomized in a 1:1 ratio to...
What is the current status of trial NCT01318642?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2012-05-31. Estimated completion is 2012-12-03.
What interventions are being tested in trial NCT01318642?
The interventions under investigation include: Placebo (DRUG), Gemcitabine (DRUG), AMG 479 (DRUG).
Who is sponsoring clinical trial NCT01318642?
This trial is sponsored by NantBioScience, which has 3 total clinical trials registered on ClinicalTrials.gov.
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