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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: Clinical Trial Phase 2 study, sponsored by NantBioScience.
NCT01318642 is a Phase 2 study that was terminated before completion, run by NantBioScience. The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The time from randomization to progression (per RECIST version 1.1) or death from any cause. Disease progression per RECIST is defined as at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study and an absolute increase of at least 5 mm; the appearance of any new lesions is also considered progression.
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 |
Why NCT01318642 stopped before completion
NCT01318642 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01318642 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01318642's enrollment target sits among peer trials
10 1968th of 2000 higher than 12 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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