Secondary objectives are to determine circulating tumour cell status at six and 12 weeks and the conversion rate of these cells, prostate-specific antigen (PSA) change rate, objective response rate (in patients with measurable disease
at baseline), effect on overall survival, the tolerability and toxicity of the treatment combination, and to explore potential molecular factors predictive of response.
Ovarian cancer patients who have no measurable disease
following their initial standard surgery and chemotherapy treatments have an unmet need that may be served by the DPX-Survivac therapy.
In addition, about half had measurable disease
, and 25% had visceral metastases, indicating mCRPC with a poor prognosis.
Eligible patients must have been treated initially with surgery, had a response to first-line platinum- and taxane-based therapy, and have relapsed as defined by the presence of measurable disease
Marek stressed the need for objective, measurable disease
markers in diagnosis and disease progression, as well as in research studies.
One patient with CLL had more than a 50 percent reduction in measurable disease
, but no improvement in disease markers in the blood.
This Phase 2 trial will also measure the direct effect of OGX-427 on PSA levels, time to progression by PSA or measurable disease
, numbers of circulating tumor cells (CTCs) and other relevant secondary endpoints.
Monk enrolled 46 women with clinically measurable disease
Those with measurable disease
only within a previous radiation therapy port must have demonstrated clear evidence of progression prior to study entry.
Response-evaluable patients were defined as patients with measurable disease
, as determined by the IRF, which met the resistance criteria for anthracyclines, taxanes, and capecitabine.
Our completed Phase I and Phase II clinical trial results show that our lead compound, DAVANAT, when co-administered with 5-Fluorouracil (5-FU), stabilized 43% of end-stage cancer patients with measurable disease
from 2 to 13 months.
The findings from this first in human MLN2704 single ascending dose trial indicated the molecule was well tolerated and produced sustained anti-tumor activity, including one patient who achieved a durable partial response in measurable disease
for 11 months, as well as a sustained prostate specific antigen (PSA) decline of more than 50 percent.