Study of GDC-0068 Or GDC-0980 With Abiraterone Acetate Versus Abiraterone Acetate in Patients With Castration-Resistant Prostate Cancer Previously Treated With Docetaxel Chemotherapy
- Conditions
- Castration-ResistantProstate CancerMedDRA version: 15.0Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-004126-10-FR
- Lead Sponsor
- Genentech Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- 258
Patients must meet all the following criteria to be eligible for study entry:
• Signed Informed Consent Form(s)
• Histologically or cytologically confirmed metastatic or advanced prostate
adenocarcinoma that has been previously treated with docetaxel and has progressed during treatment of at least one hormonal therapy (luteinizing hormone-releasing hormone, bicalutamide, etc.)
• Availability at the site of a representative formalin-fixed, paraffin-embedded
tumor specimen that enabled the definitive diagnosis of prostate cancer, accompanied by an associated pathology report (required prior to randomization)
The specimen must contain adequate viable tumor cells (= 20% for excisional
biopsy and = 50% if sample is a core biopsy).
Specimen may consist of a tissue block (preferred) or 15-20 unstained, serial
slides. Cytologic or fine-needle aspiration samples are not acceptable.
If archival tissue is either insufficient or unavailable, the patient may still be
eligible, upon discussion with the Medical Monitor, assuming the patient
Can provide = 5 unstained, serial slides
or
Is willing to consent to and undergo a pretreatment core or excisional biopsy of the tumor. Cytologic or fine-needle aspiration samples are
not acceptable.
• Two rising PSA levels = 2 ng/mL measured = 1 week apart that meet the
PCWG2 criteria for progression prior to initiation of study treatment or
radiographic evidence of disease progression in soft tissue or bone, with or
without disease progression on the basis of the PSA value
• Ongoing androgen deprivation, with serum testosterone < 50 ng/dL (< 2.0 nM/L)
• ECOG performance status of 0, 1, or 2 at screening
• Adequate hematologic and organ function within 14 days before the first study treatment, defined by the following (hematologic parameters must be
assessed = 14 days after a prior transfusion, if any):
Neutrophils (ANC = 1500/µL)
Hemoglobin = 9 g/dL
Platelet count = 100,000/µL
Total bilirubin = 1.5 × ULN with the following exception:
Patients with known Gilbert’s disease who have serum bilirubin = 3 × ULN may be enrolled.
AST and ALT = 2.5 × ULN, with the following exceptions:
Patients with documented liver metastases may have AST and/or
ALT = 5 × ULN.
Serum albumin = 3 g/dL
Serum creatinine = 1.5 × ULN or creatinine clearance of > 50 mL/min
based on a 24-hour urine collection
Fasting total serum glucose = 150 mg/dL
• Documented willingness to use an effective means of contraception
(e.g., abstinence, hormonal or double barrier method, surgically sterilized partner) while participating in the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 65
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 193
Patients who meet any of the following criteria will be excluded from study entry:
• Small cell or neuroendocrine prostate carcinoma
• History of Type I or Type II diabetes mellitus requiring insulin Patients who are on a stable dose of oral diabetes medication = 4 weeks prior to initiation of study treatment may be eligible for enrollment.
• Inability or unwillingness to swallow pills
• Malabsorption syndrome or other condition that would interfere with
enteral absorption
• Congenital long QT syndrome or QTc > 500 msec
• NYHA Class III or IV heart failure or LVEF < 50% or ventricular arrhythmia
requiring medication
• Any requirement for supplemental oxygen therapy to perform activities of daily living
• Current unstable angina or history of myocardial infarction within 6 months
prior to Day 1
• Active infection requiring IV antibiotics
• Active autoimmune disease that is not controlled by nonsteroidal
anti-inflammatory drugs or active inflammatory disease, including small or
large intestine inflammation such as Crohn’s disease or ulcerative colitis,
which requires immunosuppressive therapy
• Clinically significant history of liver disease consistent with Child-Pugh Class B or C, including viral or other hepatitis, current alcohol abuse, or cirrhosis
• History of adrenal insufficiency or hyperaldosteronism
• Known HIV infection
• Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patients at high risk from treatment complications
• Significant traumatic injury within 4 weeks prior to initiation of study treatment
(all wounds must be fully healed)
• Major surgical procedure within 4 weeks prior to initiation of study treatment
• Treatment with chemotherapy, hormonal therapy (except GnRH agonists or antagonists for prostate cancer), immunotherapy, biologic therapy, radiation therapy (except palliative radiation to bony metastases), or herbal therapy as
cancer therapy within 2 weeks prior to initiation of study treatment
• Previous therapy for prostate cancer with CYP17 inhibitors, including abiraterone and ketoconazole, or previous treatment with MDV3100
• Previous treatment for prostate cancer with Akt, PI3K, and/or mTOR inhibitors
• Need for chronic corticosteroid therapy of = 20 mg of prednisone per day or an equivalent dose of other anti inflammatory corticosteroids or immunosuppressant
• Treatment with an investigational agent within 4 weeks prior to initiation of study treatment
• Malignancies other than prostate cancer within 5 years prior to initiation of study treatment, except for adequately treated basal or squamous cell skin
cancer and non-muscle-invasive bladder cancer
• Unresolved, clinically significant toxicity from prior therapy, except for alopecia and Grade 1 peripheral neuropathy
• Inability to comply with study and follow-up procedures
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method