Adenoviral Vector Monotherapy or Combination With Chemotherapy in Subjects With Recurrent/Metastatic Breast Cancer.

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

Outcome

Outcome not reported

Stopped (Enrollment): “After SRC review and Sponsor's halting palifosfamide development, data was collected for Part 1, Arm A. Doses of 80, 100, and 140 mg were used. The SRC reduced 140 mg to 100 mg, then to 80 mg. The study ended with one subject enrolled at 80 mg daily.”

Drugs

Indications