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Prostate CancerPhase 3NCT03580239

Everolimus in Castrated Resistant Prostate Cancer(CRPC)Patients With PI3K-AKT-mTOR Signaling Pathway Deficiency

A Phase 3 study testing Everolimus in people with Prostate Cancer, run by Tianjin Medical University Second Hospital at 4 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Investigators seek a new therapeutic strategy for castrated resistant prostate cancer(CRPC) patients with PI3K-AKT-mTOR signaling pathway deficiency by next generation sequencing(NGS). Read more about this study

Who is it for?
Ages 18 to 75 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Everolimus
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
4 sitesChina
Study dates
1 Jan 2019to 1 Dec 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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 1.5109/L, platelets count is more than 80109/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.

Who cannot join

  • 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).
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  • 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.
  • 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).

Trial locations and contacts

4 sites in 1 country.

Haitao Wang, Ph.D contact

+86-88326610

peterrock2000@126.com

Haitao Wang, Ph.D contact

+86-1860955984

peterrock2000@126.com

China4 sites

  • Tianjin First Center Hospital

    Tianjin, Tianjin Municipality, 300000

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300050

  • The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

    Tianjin, Tianjin Municipality, 300150

  • Tianjin Medical Unversity Second Hospital

    Tianjin, Tianjin Municipality, 300200

Other trials in China

About this study

Official title: Placebo-Controlled, Randomized, Prospective and Multicenter Trial of Everolimus in Castrated Resistant Prostate Cancer Patients With PI3K-AKT-mTOR Signaling Pathway Deficiency

Investigators seek a new therapeutic strategy for castrated resistant prostate cancer(CRPC) patients with PI3K-AKT-mTOR signaling pathway deficiency by next generation sequencing(NGS).

Read the detailed description

The prognosis of castrated resistant prostate cancer(CRPC) is very poor.Now,there is not an ideal therapeutic strategy.Further clarifying its mechanism and finding more effective therapeutic targets on this basis are the clinical problems to be solved urgently. More and more studies have confirmed that the role of PI3K-AKT-mTOR signaling pathway in the development of castration resistance to prostate cancer.By next generation sequencing of 115 patients with CRPC, investigators found that 22% of the patients had mutations in the PI3K-AKT-mTOR signaling related genes.Investigators found that 50% of the patients could benefit from the mTOR inhibitors.But the specific clinical significance and molecular mechanism are urgently needed to be elucidated. This project is based on the hypothesis that Everolimus can target CRPC patients with PI3K-AKT-mTOR signaling pathways deficiency.So,investigators intend to peform a prospective, randomized, controlled,multicenter clinical study to find potential therapeutic targets and treatment strategies for CRPC patients.

Conditions
Prostate Cancer
Being tested
Everolimus, Placebo
Keywords
CRPC, Everolimus, mTOR
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EverolimusDrug

    Also called Novartis Pharma Schweiz AG

    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.

  • PlaceboDrug

    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.

Study groups in NCT03580239
Study groupRoleWhat they receive
Everolimus & Best Supportive CareExperimentalEverolimus 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.
Receives: Drug: Everolimus
Placebo & Best Supportive CarePlacebo comparatorPlacebo 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PFS

    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).

    Measured: 36 months

  2. OS

    Overall Survival of the Participants

    Measured: 36months

Secondary outcomes (2)

  1. ORR

    Objective Response Rate is defined as the proportion of patients with complete response(CR) or partial response(PR).

    Measured: 36 months

  2. DCR

    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.

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2018
  2. Study start1 Jan 2019 (estimated)
  3. Primary completion31 Jan 2023 (estimated)
  4. Study completion1 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03580239
Sponsor's protocol ID
CRPC-EVE
Status last verified
Jul 2018
First submitted
25 Jun 2018
Last updated
9 Jul 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Everolimus in people with Prostate Cancer, run by Tianjin Medical University Second Hospital at 4 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Haitao Wang, Ph.D (+86-88326610, peterrock2000@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (time frame: 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03580239.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2018.

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