Study of Ipatasertib or Apitolisib With Abiraterone Acetate Versus Coralie in Participants With Castration-Resistant Prostate Cancer Previously Treated With Docetaxel Chemotherapy
Status: | Active, not recruiting |
---|---|
Conditions: | Prostate Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/6/2019 |
Start Date: | January 11, 2012 |
End Date: | July 31, 2019 |
A Phase Ib/II Study of Ipatasertib (GDC-0068) or Apitolisib (GDC-0980) With Abiraterone Acetate Versus Abiraterone Acetate in Patients With Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy
This multicenter, international, Phase Ib/II trial consists of two stages: a Phase Ib,
open-label stage in which the recommended Phase II dose will be determined for ipatasertib
and apitolisib in combination with abiraterone and prednisone/prednisolone and a Phase II,
3-arm, double-blind, randomized comparison of ipatasertib with abiraterone and
prednisone/prednisolone versus placebo with abiraterone and prednisone/prednisolone.
open-label stage in which the recommended Phase II dose will be determined for ipatasertib
and apitolisib in combination with abiraterone and prednisone/prednisolone and a Phase II,
3-arm, double-blind, randomized comparison of ipatasertib with abiraterone and
prednisone/prednisolone versus placebo with abiraterone and prednisone/prednisolone.
Inclusion Criteria:
- Histologically confirmed metastatic or advanced prostate adenocarcinoma that has been
previously treated with docetaxel-based therapy and has progressed during treatment of
at least one hormonal therapy
- Two rising PSA levels greater than or equal to (>/=) 2 ng/mL measured >/= 1 week apart
or radiographic evidence of disease progression in soft tissue or bone
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening
- Adequate hematologic and organ function
- Documented willingness to use an effective means of contraception
Exclusion Criteria:
- History of Type I or Type II diabetes mellitus requiring insulin
- New York Heart Association Class III or IV heart failure or Left ventricular ejection
fraction < 50% or ventricular arrhythmia requiring medication
- Significant atherosclerotic disease, as evidenced by: unstable angina, history of
myocardial infarction within 6 months prior to Day 1, or cerebrovascular accident
within 6 months prior to Day 1
- Active autoimmune disease that is not controlled by nonsteroidal anti-inflammatory
drugs or active inflammatory disease which requires immunosuppressive therapy
- Clinically significant history of liver disease
- History of adrenal insufficiency or hyperaldosteronism
- Phase II only: Previous therapy for prostate cancer with 17
alpha-hydroxylase/C17,20-lyase inhibitors, including abiraterone
- Phase II only: Previous treatment for prostate cancer with Protein kinase B
phosphatidylinositol 3 kinase and/or mammalian target of rapamycin inhibitors
- Need for chronic corticosteroid therapy of >/= 20 mg of prednisone per day or an
equivalent dose of other anti inflammatory corticosteroids or immunosuppressant
We found this trial at
13
sites
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15681 New Hampshire Court
Fort Myers, Florida 33901
Fort Myers, Florida 33901
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823 82nd Parkway, Suite B
Myrtle Beach, South Carolina 29572
Myrtle Beach, South Carolina 29572
(843) 449-1010 ext.268
Carolina Urologic Research Center Carolina Urologic Research Center (CURC) has been recognized both nationally and...
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