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NCT01703754 · ClinicalTrials.gov registry record · Phase 2
Adenoviral Vector Monotherapy or Combination With Chemotherapy in Subjects With Recurrent/Metastatic Breast Cancer.
A Phase 2 study, sponsored by Alaunos Therapeutics.
- Terminated
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
NCT01703754: Clinical Trial Phase 2 study, sponsored by Alaunos Therapeutics.
NCT01703754 is a Phase 2 study that was terminated before completion, run by Alaunos Therapeutics. The registered enrollment target is 12 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01703754, a Phase 2 study, was terminated before completion, sponsored by Alaunos Therapeutics.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
Study Summary
Phase II, randomized, safety and efficacy study in recurrent/metastatic breast cancer with accessible lesions. Primary End point is rate of Progression Free Survival (PFS) at the 16 week treatment time point. Hypothesis: Adenoviral vector (Ad-RTS-hIL-12) alone and in combination with chemotherapy (palifosfamide) is safe and efficacious.
Primary Outcome
This measure will capture the incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and AEs leading to discontinuation. As per the protocol, safety and tolerability were assessed by monitoring adverse events, physical examinations, vital signs, electrocardiograms (ECGs), and clinical laboratory evaluations.
Interventions
- GENETIC Ad-RTS-hIL-12 and Veledimex
- DRUG Palifosfamide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2013-04-04 |
| Est. Completion | 2014-08-07 |
| Phase | Phase 2 |
Why NCT01703754 stopped before completion
NCT01703754 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which Ad-RTS-hIL-12 and Veledimex is the first listed.
NCT01703754 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01703754 about?
NCT01703754 is a clinical study titled "Adenoviral Vector Monotherapy or Combination With Chemotherapy in Subjects With Recurrent/Metastatic Breast Cancer.". Phase II, randomized, safety and efficacy study in recurrent/metastatic breast cancer with accessible lesions. Primary End point is rate of Progression Free Survival (PFS) at the 16 week treatment time point. Hypothesis: Adenoviral vector (Ad-RTS-hIL-12) alone and in combination with chemotherapy (...
What is the current status of trial NCT01703754?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2013-04-04. Estimated completion is 2014-08-07.
What interventions are being tested in trial NCT01703754?
The interventions under investigation include: Ad-RTS-hIL-12 and Veledimex (GENETIC), Palifosfamide (DRUG).
Who is sponsoring clinical trial NCT01703754?
This trial is sponsored by Alaunos Therapeutics, which has 22 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01703754's enrollment target sits among peer trials
12 1948th of 2000 higher than 34 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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