Spots Global Cancer Trial Database for Adenoviral Vector Monotherapy or Combination With Chemotherapy in Subjects With Recurrent/Metastatic Breast Cancer.

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Trial Identification

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

Official Title: A Phase II Randomized, Open Label Study of Ad-RTS-hIL-12 Monotherapy or Combination With Palifosfamide in Subjects With Recurrent/Metastatic Breast Cancer and Accessible Lesions

Study ID: NCT01703754

Conditions

Breast Cancer Nos Metastatic Recurrent

Interventions

Ad-RTS-hIL-12 and Veledimex

Palifosfamide

Study Description

Brief 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.

Detailed Description: Multicenter, open-label, randomized study evaluating the safety and efficacy of INXN-1001 (veledimex) and INXN-2001 (Ad-RTS-hIL-12) alone and in combination with palifosfamide. Part 1 is the safety run-in where a safety assessment will be made after 1 cycle of therapy. Part 2, eligible subjects will be randomly assigned to active treatment Arms A or C. Once the monotherapy (Arm A) is determined to be safe and tolerable, Part 1 combination therapy (Arm C) will begin. Subjects should receive six cycles of study treatment, in the absence of meeting withdrawal criteria.