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NCT01220128 · ClinicalTrials.gov registry record · Phase 2
Evaluation of an Anti-cancer Immunotherapy Combined With Standard Neoadjuvant Treatment in Patients With WT1-positive Primary Invasive Breast Cancer
A Phase 2 study, sponsored by GlaxoSmithKline.
- Terminated
- Registry status
- Phase 2
- Development phase
- 66
- Enrollment target
NCT01220128: Clinical Trial Phase 2 study, sponsored by GlaxoSmithKline.
NCT01220128 is a Phase 2 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 66 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01220128, a Phase 2 study, was terminated before completion, sponsored by GlaxoSmithKline.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 66 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety, immunogenicity and clinical activity of a new WT1 anti-cancer immunotherapy in patients with WT1-positive Stage II or III breast cancer. The treatment will be given before surgery in combination with standard therapy.
Primary Outcome
Severe toxicity was defined as follows: - A Grade 3 or higher toxicity that is related or possibly related to the combined administration of standard treatment and GSK2302024A/placebo - A decrease in Left Ventricular Ejection Fraction (LVEF) from baseline with ≥ 10 points and at \< 50% that is related or possibly related to the combined administration of treatment and that is confirmed by a second LVEF assessment within approximately 3 weeks. - A Grade 2 or higher cardiac ischemia/infarction tha
Interventions
- DRUG Placebo
- DRUG 5-Fluorouracil
- DRUG Aromatase inhibitor
- DRUG Carboplatin AUC
- BIOLOGICAL GSK Biologicals' recombinant WT1 Antigen-Specific Cancer Immunotherapeutic (ASCI) GSK2302024A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2011-04-11 |
| Est. Completion | 2014-11-14 |
| Phase | Phase 2 |
Why NCT01220128 stopped before completion
NCT01220128 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT01220128 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01220128 about?
NCT01220128 is a clinical study titled "Evaluation of an Anti-cancer Immunotherapy Combined With Standard Neoadjuvant Treatment in Patients With WT1-positive Primary Invasive Breast Cancer". The purpose of this study is to evaluate the safety, immunogenicity and clinical activity of a new WT1 anti-cancer immunotherapy in patients with WT1-positive Stage II or III breast cancer. The treatment will be given before surgery in combination with standard therapy.
What is the current status of trial NCT01220128?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 66 participants. The study started on 2011-04-11. Estimated completion is 2014-11-14.
What interventions are being tested in trial NCT01220128?
The interventions under investigation include: Placebo (DRUG), 5-Fluorouracil (DRUG), Aromatase inhibitor (DRUG), Carboplatin AUC (DRUG), GSK Biologicals' recombinant WT1 Antigen-Specific Cancer Immunotherapeutic (ASCI) GSK2302024A (BIOLOGICAL).
Who is sponsoring clinical trial NCT01220128?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01220128's enrollment target sits among peer trials
66 975th of 2000 higher than 1,014 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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