Everolimus in Castrated Resistant Prostate Cancer(CRPC)Patients With PI3K-AKT-mTOR Signaling Pathway Deficiency
NCT ID: NCT03580239
Last Updated: 2018-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
120 participants
INTERVENTIONAL
2019-01-01
2023-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Everolimus & Best Supportive Care
Everolimus will be administered at a dose of 10mg/day orally once a day. One cycle of therapy consists of 28 days.The patients also receive the best supportive care.
Everolimus
Everolimus will be treated at a dose of 10mg/day orally once a day. One cycle of therapy consists of 28 days. The patients also receive the best supportive care.
Placebo & Best Supportive Care
Placebo will be administered at a dose of 10mg/day orally once a day. One cycle of therapy consists of 28 days.The patients also receive the best supportive care.
Placebo
Placebo will be treated at a dose of 10mg/day orally once a day. One cycle of therapy consists of 28 days. The patients also receive the best supportive care.
Interventions
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Everolimus
Everolimus will be treated at a dose of 10mg/day orally once a day. One cycle of therapy consists of 28 days. The patients also receive the best supportive care.
Placebo
Placebo will be treated at a dose of 10mg/day orally once a day. One cycle of therapy consists of 28 days. The patients also receive the best supportive care.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients with histologically or cytologically confirmed prostate cancer.
3. Conventional treatment failed advanced CRPC patients,routine treatment including:radical prostatic cancer surgery,castration, ADT, amieton /inololamine new endocrine therapy,docetaxel intravenous drug resistance, or intolerance of toxic and side effects.
4. Patients must be able to provide blood samples or tissue samples for testing. The amount of blood samples should be able to meet the requirements of DNA extraction and quality control:
I.Sample type: DNA samples without RNA degradation and pollution free.
II.A single sample size of more than 500 ng (using Roche library platform,Illumina sequencing platform).
III.The sample concentration is more than 40 ng/L (using Roche building database platform; Illumina sequencing platform); IV.The purity of the sample is OD 260/280=1.8\~2;
5. After next generations of sequencing, all the patients were found to have defects in the PI3K-AKT-mTOR signaling pathway, including the following molecular markers: PI3K, AKT, mTOR, PTEN, TSC1, TSC2 and so on.
6. The expected survival time is more than 4 weeks.
7. Patients with Karnofsky(KPS) functional status score \> 60 and Eastern Cooperative Oncology Group(ECOG)state score 0-2 points.
8. Patients organ function level must comply with the following requirements:
I.Hematological parameters: the absolute count of neutrophils is more than 1.5\*109/L, platelets count is more than 80\*109/L, hemoglobin is more than 9g/dL (which can be maintained by blood transfusion).
II.Liver function: the upper limit of the normal value of total bilirubin less than 1.5 times, the upper limit of normal value of alanine aminotransferase and glutamic pyruvic aminotransferase, less than 2.5 times the normal value, such as the liver metastasis and the upper limit of the normal value of the aminotransferase less than 5 times; Child-Pugh grade of liver function: A and a better B grade (less than 7); Barcelona Clinic Liver Cancer(BCLC)staging: B-C stage.
III.Renal function: creatinine is less than 1.25 times the normal upper limit, and the creatinine clearance rate is more than 60ml/min.
9. Patients who adherence to research and follow-up procedures.
10. Patients who can understand and voluntarily sign informed consent.
Exclusion Criteria
2. Patients who received chemotherapy, biotherapy or other anticancer drugs is less than 4 weeks.
3. Patients with the following and above conditions:
I.Patients with symptomatic central nervous system metastases or spinal cord compression.
II.Patients with peripheral neuropathy symptoms, grade NCI(National Cancer Institute)\>gradeII.
III.Patients with any unstable systemic disease (including active infection, poor control of hypertension,unstable angina,congestive heart failure, liver, kidney or metabolic diseases).
IV.Patients with severe pulmonary interstitial changes, pulmonary fibrosis, and irreversible respiratory insufficiency.
V.Patients who are not receiving oral administration, need high energy intravenous nutrition, have undergone previous operations affecting absorption, active gastrointestinal ulcer and chronic diarrhea.
VI. Patients with serious, uncontrolled medical and infectious diseases. VII. Patients with severe electrolyte imbalance. VIII. Patients with diffuse intravascular coagulation. IX. Patients who known allergies to platinum and Everolimus targeted drugs
4. Patients with cognitive and psychological abnormality
5. Patients who use other test drugs or participate in other clinical trials.
6. Researchers believe that subjects may not be able to complete the study or may not be able to comply with the requirements of this study (for management or other reasons).
18 Years
75 Years
MALE
No
Sponsors
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Tianjin Medical University General Hospital
OTHER
Tianjin First Central Hospital
OTHER
The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine，China
UNKNOWN
Tianjin Medical University Second Hospital
OTHER
Responsible Party
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Locations
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Tianjin First Center Hospital
Tianjin, Tianjin Municipality, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, China
Tianjin Medical Unversity Second Hospital
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Other Identifiers
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CRPC-EVE
Identifier Type: -
Identifier Source: org_study_id
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