The purpose of this study is to assess the antitumor activity of weekly ridaforolimus study treatment in participants with taxane-resistant AIPC.
The primary objective of this phase II study is to assess the anti-cancer activity of weekly ridaforolimus administration in participants with taxane-resistant AIPC. Other objectives include evaluating experimental parameters that may predict or indicate response to mTOR inhibition, such as effects on plasma VEGF, markers of tumoral PI3K/mTOR-pathway activity, and proteomic analysis. The inclusion of these evaluations in this trial may provide insight into the identification of markers that may be helpful in optimizing ridaforolimus treatment and in identifying patients with ridaforolimus-sensitive tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Louis Warchaw Prostate Cancer Center, Cedars-Sinai Medical Center
Los Angeles, California, United States
Beth Israel Deaconess Medical Center/MGH/DFCI
Boston, Massachusetts, United States
The Methodist Hospital Research Institute
Houston, Texas, United States
University of Wisconsin, Madison, WI
Madison, Wisconsin, United States
Best Overall Response (BOR) per Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: Up to 24 months
Number of Participants Experiencing at Least One Adverse Event
Time frame: Up to 25 months
Change from Baseline in Prostate-Specific Antigen (PSA)
Time frame: Baseline and up to 24 months
Time to Tumor Progression (TTP)
Time frame: Up to 24 months
Progression-Free Survival (PFS)
Time frame: Up to 24 months
Overall Survival (OS)
Time frame: Up to 24 months
Duration of Response (DOR)
Time frame: Up to 24 months
Change from Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) Score
Time frame: Baseline and up to 24 months
Change from Baseline in Plasma Vascular Endothelial Growth Factor (VEGF)
Time frame: Baseline and Day 28 of Cycles 1 and 2 (Up to 56 days)
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