A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer
The purpose of this study is to find out whether the new drug PX-866 will slow the growth of your prostate cancer. The investigators will also watch you carefully for any side effects that PX-866 might cause.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer|
- Efficacy [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Part A: To determine the efficacy of PX-866 when given orally daily (1 reporting period=6 weeks), in patients with castration resistant prostate cancer, who have received no prior chemotherapy regimens for recurrent disease. Efficacy will be based on the lack of disease progression (progression is defined in Section 10) measured at 12 weeks.
Part B: To determine the efficacy of PX-866 when given orally daily (1 reporting period=6 weeks), in patients with castration resistant prostate cancer, who have had PSA progression while receiving abiraterone/prednisone. Efficacy will be based on the lack of disease progression (progression is defined in Section 10) measured at 12 weeks.
- Tolerability and toxicity of PX-866 in this population [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]To access the side effects PX-866 may have in patients
- PSA response; Objective response and change in circulating tumour cell number [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
To investigate additional potential measures of efficacy including:
- PSA response rate
- Objective response rate (in patients with measurable disease at baseline)
- Change in circulating tumour cell number during treatment
- Access if PX-866 inhibits a molecule related to cancer cell growth [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]To explore potential molecular factors predictive of response by assessment of archival prostate tumour tissue (Part A and B) and baseline circulating tumour cells (Part A only).
- Access effect of PX-866 on platelets [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]In selected participating centres, in Part A only, to determine evidence of effect on PI3K activation pre- and post-administration of PX-866 in platelets.
|Study Start Date:||May 2011|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
PX 866 is a new type of drug that inhibits a molecule related to cancer cell growth. While this molecule is also found in normal cells, it is much more active in some cancer cells, so inhibiting the molecule with PX-866 is hoped to slow the growth of cancer cells. Laboratory tests show that it may help slow the growth of prostate cancer in animals, but it is not known whether it will have the same effects in humans. PX-866 has been studied in some cancer patients to find out safe doses that can be given but it has not undergone study in prostate cancer. This study will be the first study of PX-866 in prostate cancer.
Health Canada has not approved the sale or use of PX-866 to treat prostate cancer, although they have approved its use in this clinical trial.
|Tom Baker Cancer Centre|
|Calgary, Alberta, Canada, T2N 4N2|
|Cross Cancer Institute|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Canada, British Columbia|
|BCCA - Cancer Centre for the Southern Interior|
|Kelowna, British Columbia, Canada, V1Y 5L3|
|BCCA - Vancouver Cancer Centre|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Canada, Nova Scotia|
|QEII Health Sciences Centre|
|Halifax, Nova Scotia, Canada, B3H 1V7|
|Juravinski Cancer Centre at Hamilton Health Sciences|
|Hamilton, Ontario, Canada, L8V 5C2|
|Cancer Centre of Southeastern Ontario at Kingston|
|Kingston, Ontario, Canada, K7L 5P9|
|London Regional Cancer Program|
|London, Ontario, Canada, N6A 4L6|
|Univ. Health Network-Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Allan Blair Cancer Centre|
|Regina, Saskatchewan, Canada, S4T 7T1|
|Study Chair:||Kim Chi||BCCA Vancouver Cancer Centr|
|Study Chair:||Sebastien Hotte||Juravinski Cancer Centre at Hamilton Health Sciences|