- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03580239
Everolimus in Castrated Resistant Prostate Cancer(CRPC)Patients With PI3K-AKT-mTOR Signaling Pathway Deficiency
Placebo-Controlled, Randomized, Prospective and Multicenter Trial of Everolimus in Castrated Resistant Prostate Cancer Patients With PI3K-AKT-mTOR Signaling Pathway Deficiency
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Haitao Wang, Ph.D
- Phone Number: +86-88326610
- Email: peterrock2000@126.com
Study Contact Backup
- Name: Haitao Wang, Ph.D
- Phone Number: +86-1860955984
- Email: peterrock2000@126.com
Study Locations
-
-
Tianjin
-
Tianjin, Tianjin, China, 300000
- Tianjin First Center Hospital
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Tianjin, Tianjin, China, 300050
- Tianjin Medical University General Hospital
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Tianjin, Tianjin, China, 300150
- The Second Affiliated Hospital of Tianjin University of traditional Chinese Medicine
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Tianjin, Tianjin, China, 300200
- Tianjin Medical Unversity Second Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients diagnosed with advanced refractory castration resistant prostate cancer(CRPC).
- Patients with histologically or cytologically confirmed prostate cancer.
- 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.
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;
- 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.
- The expected survival time is more than 4 weeks.
- Patients with Karnofsky(KPS) functional status score > 60 and Eastern Cooperative Oncology Group(ECOG)state score 0-2 points.
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.
- Patients who adherence to research and follow-up procedures.
- Patients who can understand and voluntarily sign informed consent.
Exclusion Criteria:
- Patients with other malignant tumors over the last 5 years.
- Patients who received chemotherapy, biotherapy or other anticancer drugs is less than 4 weeks.
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
- Patients with cognitive and psychological abnormality
- Patients who use other test drugs or participate in other clinical trials.
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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 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 Names:
|
Placebo Comparator: 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 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PFS
Time Frame: 36 months
|
Progression free survival of All the Evaluable Participants.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0).(Note: the appearance of one or more new lesions is also considered progression).
|
36 months
|
OS
Time Frame: 36months
|
Overall Survival of the Participants
|
36months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ORR
Time Frame: 36 months
|
Objective Response Rate is defined as the proportion of patients with complete response(CR) or partial response(PR).
|
36 months
|
DCR
Time Frame: 36 months
|
Disease control is defined as the proportion of patients who had a best response rating of complete response, partial response, or stable disease, and lasted at least 4 weeks.
|
36 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRPC-EVE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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