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Protein Kinase Inhibitor
LAE001 + Prednisone + Afuresertib for Prostate Cancer
Phase 1 & 2
Waitlist Available
Research Sponsored by Laekna Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have adequate renal function as evidenced by a serum creatinine of ≤1.5 × ULN for the reference laboratory or creatinine clearance ≥30 mL/min within the 28 days before enrollment.
Patients must have documented histological or cytological evidence of adenocarcinoma of the prostate (excluding neuroendocrine differentiation or small cell histology).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Awards & highlights
Study Summary
This trial is testing a combination of two drugs, afuresertib and LAE001, to see if they are effective in treating patients with m-CRPC who have progressed/ become drug resistant following prior standard care treatments.
Who is the study for?
This trial is for men over 18 with advanced prostate cancer that's resistant to castration and has spread, despite previous anti-androgen treatments. They must have a certain level of health, including stable blood sugar and kidney function, no major surgeries or infections recently, and not be on conflicting medications. Men must agree to use contraception if their partner can bear children.Check my eligibility
What is being tested?
The study tests combining LAE001/prednisone with afuresertib in men whose prostate cancer has worsened after standard care. It aims to find the best dose mix for those intolerant or unresponsive to two prior anti-androgen therapies or chemotherapy.See study design
What are the potential side effects?
Potential side effects may include issues related to hormone therapy like fatigue, hot flashes, mood swings; prednisone might cause weight gain or sleep problems; afuresertib could lead to digestive upset or rash. Specific side effects will depend on how patients react to the drug combination.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function is within the normal range based on recent tests.
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My prostate cancer is confirmed by lab tests and is not a neuroendocrine or small cell type.
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I have metastatic castration-resistant prostate cancer and have tried at least one treatment.
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My prostate cancer has spread, as confirmed by scans.
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My testosterone levels are very low.
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I have mCRPC and have had 1-3 prior treatments, including a second-gen antiandrogen, but no more than one chemo.
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I can take care of myself and am up and about more than half of my waking hours.
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I can take pills and don't have stomach or bowel problems affecting drug absorption.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Combined Modality Therapy
Phase II: Radiological progression free survival (rPFS) based changes per Prostate Cancer Working Group 3 (PCWG3)
Phase II: Radiological progression free survival (rPFS) based on change in tumor per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Secondary outcome measures
Phase I: Best PSA response
Phase I: Changes in Prostate Specific Antigen (PSA) levels
Phase I: Describe pharmacodynamics of study drugs
+21 moreOther outcome measures
Phase I: Explore correlation between anti-tumor activity and patient's BRCA mutation status
Phase I: Explore correlation between anti-tumor activity and patient's PTEN status
Phase I: Relationship between PSA levels and testosterone levels
Trial Design
6Treatment groups
Experimental Treatment
Group I: Phase II Cohort 2Experimental Treatment1 Intervention
Docetaxel/prednisone + afuresertib
Group II: Phase II Cohort 1Experimental Treatment1 Intervention
LAE001 (capsules) + prednisone (tablet) +afuresertib at the Recommended Phase II Dose (RP2D)
Group III: Phase I Cohort 4Experimental Treatment1 Intervention
LAE001 (capsules) 100mg BID + prednisone (tablet) 5mg BID +afuresertib (tablet) 150mg QD will be administered in Cycles of 28 days.
Group IV: Phase I Cohort 3Experimental Treatment1 Intervention
LAE001 (capsules) 100mg BID + prednisone (tablet) 5mg BID +afuresertib (tablet) 125mg QD will be administered in Cycles of 28 days.
Group V: Phase I Cohort 2Experimental Treatment1 Intervention
LAE001 (capsules) 100mg BID + prednisone (tablet) 5mg BID +afuresertib (tablet) 100mg QD will be administered in Cycles of 28 days.
Group VI: Phase I Cohort 1Experimental Treatment1 Intervention
LAE001 (capsules) 75mg Twice Daily (BID) + prednisone (tablet) 5mg BID +afuresertib (tablet) 100mg Once Daily (QD) will be administered in Cycles of 28 days.
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Who is running the clinical trial?
Laekna LimitedLead Sponsor
5 Previous Clinical Trials
368 Total Patients Enrolled
Yong Yue, MDStudy ChairLaekna Therapeutics
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need medication that reduces potassium in my body.My blood pressure hasn't been stable for the last month.I have a history of issues with my hypothalamus, pituitary gland, or adrenal glands.My kidney function is within the normal range based on recent tests.I am not on long-term steroids or other drugs that weaken my immune system.I stopped taking hormone therapy for prostate cancer over 6 weeks ago and my PSA levels are still rising.I haven't had major surgery in the last 28 days or still recovering from one.My prostate cancer is confirmed by lab tests and is not a neuroendocrine or small cell type.I finished Provenge treatment less than 6 weeks ago.My prostate cancer has spread, as confirmed by scans.I am a sexually active male willing to use a condom during and for 16 weeks after the study.I have been treated with AKT, PI3K, or mTOR inhibitors before.I have a heart condition or have had heart problems in the past.I have metastatic castration-resistant prostate cancer and have tried at least one treatment.I do not have severe nerve pain or damage.My testosterone levels are very low.I haven't had severe stomach bleeding or uncontrolled stomach issues in the last 3 months.I have mCRPC and have had 1-3 prior treatments, including a second-gen antiandrogen, but no more than one chemo.I have not started a new hormone therapy for my cancer in the last 6 weeks.I stopped taking Radium Ra 223 or Samarium Sm 153 more than 7 or 2 weeks ago, respectively.I have prostate cancer that has spread to my brain or spine, or I'm at high risk for spinal cord compression.I am not on medications that strongly affect liver enzymes CYP1A or CYP3A.I have an active HIV, hepatitis B, or hepatitis C infection.I do not have another cancer that needs treatment right now.I haven't needed treatment for an infection in the last 10 days.I've been on a stable dose of bone support medication for at least 12 weeks.I have not had radiation for the cancer area I want treated in this study within the last 4 weeks.I am a man over 18 and can sign a consent form.I can take care of myself and am up and about more than half of my waking hours.I can take pills and don't have stomach or bowel problems affecting drug absorption.
Research Study Groups:
This trial has the following groups:- Group 1: Phase I Cohort 1
- Group 2: Phase I Cohort 3
- Group 3: Phase I Cohort 2
- Group 4: Phase II Cohort 1
- Group 5: Phase II Cohort 2
- Group 6: Phase I Cohort 4
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has there been any previous research done utilizing the combination of LAE001/prednisone and afuresertib in Phases I and II?
"LAE001/prednisone + afuresertib was first investigated in 2001 at Providence Cancer Center and subsequently reviewed in 606 clinical trials since. Presently, 336 active studies are enrolling patients with a significant portion taking place near Tacoma, Washington."
Answered by AI
Are there multiple facilities administering this clinical experiment across the state?
"Currently, 14 different sites are hosting this medical trial. These locations include Tacoma, Topeka and Temple among many others. It is highly recommended that potential participants select the closest clinic to reduce travel burden associated with participation in this study."
Answered by AI
Does this trial have room to enrol more participants?
"Affirmative, according to clinicaltrials.gov this trial is still open for enrollment and began doing so on September 13th 2019. Its most recent update was November 30th 2022 and it requires 74 participants from 14 different research centres."
Answered by AI
What is the cap on enrollment for this medical experiment?
"Affirmative. Clinicaltrials.gov records demonstrate that this trial is presently in the process of recruiting candidates, having first been made available on September 13th 2019 and last updated November 30th 2022. 74 test subjects are being sought from 14 different sites for participation."
Answered by AI
What are the main goals of this medical experiment?
"The primary outcome of this 12-month medical study revolves around assessing the Radiological Progression Free Survival (rPFS) according to the PCWG3 guidelines. Secondary objectives include measuring Overall Response Rate (ORR), Disease Control Rate (DCR), and changes in Prostate Specific Antigen levels over time."
Answered by AI
What afflictions are treated through the combined administration of LAE001/prednisone and afuresertib during Phases I and II?
"LAE001/prednisone + afuresertib is a viable treatment option for those dealing with thyroiditis, ulcerative colitis, or malignant neoplasms during Phase I and II."
Answered by AI
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