drugset / Trial / NCT01703754
Adenoviral Vector Monotherapy or Combination With Chemotherapy in Subjects With Recurrent/Metastatic Breast Cancer.
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2013-04-04
- Primary completion
- 2014-08-07
- Completion
- 2014-08-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ad-RTS-hIL-12 | Unknown | — | Other |
| Subject | Palifosfamide | Small molecule | — | Intravenous |
| Subject | veledimex | Small molecule | — | Oral |