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Metastatic Castration-resistant Prostate CancerPhase 1/2NCT04060394

Dose-Escalation and Efficacy Study of LAE001/Prednisone Plus Afuresertib Patients With m-CRPC

A Phase 1/2 study testing Phase I and Phase II: LAE001/prednisone + afuresertib in people with Metastatic Castration-resistant Prostate Cancer, run by Laekna Limited at 17 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The combination treatment of protein kinase B (AKT) inhibitor, afuresertib, with androgen synthesis enzyme inhibitor, LAE001, may provide an effective treatment for metastatic castration resistant prostate cancer (m-CRPC) patients who have progressed/drug resistant following prior standard care treatments of any… Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Phase I and Phase II: LAE001/prednisone + afuresertib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
17 sitesin 2 countries
Study dates
13 Sep 2019to 30 Mar 2024
Phase
Phase 1/2
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 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients, males ≥18 years of age, must be able to provide written informed consent.
  • Patients must have documented histological or cytological evidence of adenocarcinoma of the prostate (excluding neuroendocrine differentiation or small cell histology).
  • Patients must have radiographic evidence of metastatic disease for mCRPC based on the 'Guideline of American Urological Association for Prostate Cancer' before study enrollment. (https://www.auanet.org/guidelines/prostate-cancer-castration-resistant11 guideline)
  • For PTEN and PIK3CA/AKT status test:
  • Phase I: The PTEN/PIK3CA/AKT status test is optional and the result could be either positive, negative, undetermined or invalid. Phase II: Patients will be allowed to enroll regardless of the biomarker status, medical monitor review is necessary before enrollment. The biomarker status tests will be performed with the following order. The biomarker results of all enrolled patients will be used for retrospective analysis purposes.
  • Patients that have a documentation of "PTEN LOSS" and/or PTEN/PIK3CA/AKT alteration from a previous test on either tissue or liquid biopsy (e.g., IHC or next generation sequencing NGS), no further biomarker tests are needed in this study.
Show all 33Show fewer
  • Patients who have PTEN or PI3KPIK3CA/AKT alteration status reported other than "PTEN LOSS", "PIK3CA/AKT alterations" or never completed any PTEN/PIK3CA/AKT test before, could either provide the archival tumor samples collected at any time before study enrollment or do a fresh core tumor biopsy.
  • As the last option, patients can perform a liquid biopsy for PTEN LOSS and PTEN/PIK3CA/AKT alteration tests by NGS of cfDNA if they have no archival tissue to provide, no tumor lesion for biopsy or a fresh biopsy is not feasible.
  • Patients must have progressive disease based on the PCWG3 criteria:
  • Patients who progressed based solely on total PSA rising, should have had a sequence of rising values on 3 consecutive occasions of at least 1-week intervals (if the third measurement is not greater than the second measurement, a fourth measurement at least a week apart must be taken and must be greater than the second measurement) and should have 2.0 ng/mL minimum level for entry. Note: Patient must have had a prior PSA response, followed by documented PSA progression on prior hormone treatment.
  • Patients who have documented disease progression per RECIST 1.1 are eligible independent of PSA.
  • Patients with bone only progression according to PCWG3 (i.e., bone scan showing
  • appearance of ≥2 new lesions).
  • Patients must have castration levels of testosterone (<50 ng/dL or 1.7 nmol/L). Note: Patients must have undergone androgen deprivation therapy (ADT), such as orchiectomy, or have been on luteinizing hormone releasing hormone (LHRH) agonists or antagonists, for at least 3 months prior to study enrollment. Patients on LHRH agonists/antagonists must remain on these agents for the duration of the study.
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
  • Patients must have adequate hematopoietic function by local laboratory within the 28 days before enrollment, as evidenced by:
  • Absolute neutrophil count ≥1,500/μL
  • Platelet count ≥75,000/μL
  • Hemoglobin ≥9 g/dL
  • Note: Criteria must be met without growth factors or transfusion within 10 days prior to the screening lab tests. Total serum bilirubin ≤1.5 × ULN within the 28 days before enrollment (in patients with known Gilbert's syndrome, total bilirubin ≤3 × ULN with direct bilirubin ≤1.5 × ULN).
  • Aspartate aminotransferase and alanine aminotransferase ≤2.5 × ULN except for patients with tumor involvement of the liver who must have AST and ALT ≤5 × ULN within the 28 days before enrollment.
  • 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 (calculated from Cockcroft-Gault formula or 24-hour urine collection).
  • Serum potassium ≥3.5 mmol/L and < ULN within the 28 days before enrollment.
  • Fasting plasma glucose (fasting is defined as no caloric intake for at least 8 hours):
  • ≤126 mg/dL for those patients without a pre-existing diagnosis of Type 1 or Type 2 diabetes mellitus
  • ≤167 mg/dL for those patients with a pre-existing diagnosis of Type 2 diabetes mellitus AND glycosylated haemoglobin (HbA1C) ≤8%
  • Phase I: Patients who have mCRPC progressed or are intolerant after receiving at least 1 prior treatments of any anti-androgen (such as abiraterone, enzalutamide, apalutamide, or any other AR antagonists that are approved later), and/or chemotherapy. Patients must have at least 3 weeks of treatment of any antiandrogen and/or completed at least 4 Cycles of docetaxel or cabazitaxel treatment before their screening visit.
  • Phase II: Patients who have mCRPC progressed or are intolerant after receiving 1-3 prior standard treatments for mCSPC, or nmCRPC, or mCRPC, including at least one second-generation antiandrogen treatment (i.e., abiraterone, enzalutamide, apalutamide, or darolutamide), and no more than one chemotherapy. Patients must have at least 3 weeks of treatment of any antiandrogen and/or completed at least 3 Cycles of docetaxel or cabazitaxel treatment and/or at least 3 injections of R223 and/or at least 2 injections of sipuleucel-T to be counted as one prior therapy. Patient's current diagnosis at screening must be mCRPC.
  • Concomitant use of bisphosphonates and other bone supportive agents is allowed if the dose and renal function have been stable for at least 12 weeks before enrollment and no related ≥Grade 2 side effects are present for at least 4 weeks prior to study drug treatment. The minimum washout period is 4 weeks for prostate cancer therapy (cytotoxic, biologics, antiandrogens, etc.) before enrollment, starting from the day the therapies were stopped.
  • Patients with a female partner of childbearing potential must agree to use condoms plus an additional contraceptive method to avoid conception until the end of relevant systemic exposure plus 90 days following the Clinical Trial Facilitation Group contraception guideline from September 2014.
  • Patient should be suitable for oral medication and should not have any known gastrointestinal diseases that may interfere with drug absorption.
  • Life expectancy of at least 6 months.

Who cannot join

  • Major surgery within 28 days before study treatment and/or have not adequately (Grade 1) recovered from the adverse effects of any major surgical procedures before study treatment.
  • Patients that received other second-line ADT (including but not limited to ketoconazole and amino glutethimide) within 6 weeks before enrollment.
  • Patients who have completed sipuleucel-T (Provenge®) treatment within 6 weeks of enrollment.
  • Patients who have received antiandrogens such as flutamide (EULEXIN®), bicalutamide (CASODEX®), or nilutamide (NILANDRON®) for >3 months must be off treatment for 6 weeks prior to enrollment and should demonstrate a continued rise in PSA after withdrawal.
  • Patients who have received Radium Ra 223 dichloride (XOFIGO®) must be off therapy for 7 weeks prior to enrollment or Samarium Sm 153 lexidronam (QUADRAMET®) must be off therapy for at least 2 weeks prior to enrollment.
  • Patients that are currently receiving increasing or chronic treatment (>5 days) with corticosteroids or another immunosuppressive agent, other than the following: daily use of up to 10 mg prednisone (or equivalent) or low-dose steroid for the control of nausea and vomiting, topical steroid, or inhaled steroid use.
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  • Patients who require potassium-wasting diuretics.
  • Patients who have received any investigational agent beyond those indicated for the treatment of prostate cancer within 5 half-lives of the agent; if the half-life of the agent is not known, the patients must be off investigational therapy for 4 weeks prior to enrollment (whichever is shorter of the two should be preferred).
  • Patients who have received palliative and other radiotherapy for the target lesion within 4 weeks of study enrollment.
  • Patients with symptomatic or known central nervous system metastases from prostate cancer or who are at high risk for spinal cord compression, per investigator's judgment.
  • Patients with a history of hypothalamus, pituitary or adrenal insufficiency.
  • Patients with >grade 2 neuropathy at study enrollment.
  • History of another primary malignancy that is currently clinically significant or currently requires active intervention.
  • Inadequately controlled hypertension (eg, systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥95 mmHg) or hypotension (eg, systolic blood pressure ≤ 80 mmHg or diastolic blood pressure ≤50 mmHg) after up to 3 measurements with at least 5 minutes apart during 28 days before study enrollment.
  • Patients with active cardiac disease or a history of cardiac dysfunction including any of the following:
  • Severe or unstable angina pectoris or acute coronary syndrome or stroke within 6 months prior to study enrollment.
  • Symptomatic pericarditis.
  • Documented myocardial infarction or arterial thrombotic events within 6 months prior to study enrollment.
  • History of documented congestive heart failure (New York Health Association functional classification III to IV).
  • Documented history of cardiomyopathy.
  • Known left ventricular ejection fraction <50% as determined by multiple gated acquisition scan or echocardiogram within 28 days prior to enrollment.
  • History of clinically significant cardiac arrhythmias unsuitable to participate, as determined by the investigator.
  • Patients with a Fridericia-corrected QT (QTcF) interval of >470 msec on the screening ECG (using the QTcF formula), has a short/long QT syndrome, or history of QT prolongation/Torsades de Pointes, unless prolonged QTc interval is due to (right or left) bundle branch block and/or pacemaker rhythm. If wide QRS complex is present, cardiology consultation is required to assess the risk for Torsade de Pointes.
  • Patients with a history of an active infection (viral, bacterial, or fungal) requiring systemic therapy within 10 days before enrollment, including but not limited to tuberculosis.
  • Patients who have active human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infections.
  • Patients that are currently receiving treatment with drugs known to be moderate or strong inhibitors or inducers of isoenzyme CYP1A (including but not limited:
  • α-Naphthoflavone, Furafylline, Omeprazole, Lansoprazole) and isoenzyme CYP3A (including but not limited: Itraconazole, Ketoconazole, Azamulin, Troleandomycin, Verapamil, Rifampicin). The patients must have discontinued moderate or strong inducers for at least 2 weeks prior to study enrollment and must have discontinued moderate or strong inhibitors for at least 1 week before study enrollment. Spironolactone Strong bile salt export pump (BSEP) inhibitors, grapefruit juice, herbal medicines such as St. John's wort, Kava, ephedra, gingko biloba, dehydroepiandrosterone, yohimbe, saw palmetto and ginseng should be discontinued.
  • Sexually active males not willing to use a condom during the whole course of the study and for 16 weeks after stopping treatment. Male patients must not father a child in this period. A condom is required to be used also by vasectomized men as well as during intercourse with a male partner in order to prevent delivery of the drug via seminal fluid.
  • Patients with any other medical, psychiatric, or social condition, including substance abuse, which in the opinion of the investigator, would preclude participation in the study.
  • Patients with a history of upper gastrointestinal bleeding or uncontrolled peptic disease in the previous 3 months which in Investigator's opinion may impact patient's participation in the study.
  • Patients have previously received AKT or PI3 kinase pathway or mTOR inhibitors

Trial locations and contacts

17 sites in 2 countries.

17 sites in 2 countries

United States12 sites

  • University of Chicago

    Chicago, Illinois, 60637

  • Piedmont Columbus Regional Research Institute

    Columbus, Georgia, 31901

  • Mary Crowley Cancer Research Centers

    Dallas, Texas, 75251

  • California Cancer Associates for Researh & Excellence, Inc

    Encinitas, California, 92024

  • Oregon Urology Institute

    Florence, Oregon, 97439

  • Greenville Hospital System

    Greenville, South Carolina, 29605

  • Eastern Connnecticut Hematology/Oncology Associates

    Norwich, Connecticut, 06360

  • Associated Medical Professionals of NY

    Syracuse, New York, 13215

  • Northwest Medical Specialties, PLLC

    Tacoma, Washington, 98405

  • Baylor Scott and White Health

    Temple, Texas, 76508

  • Cotton-O'Neil Clinical Research Center

    Topeka, Kansas, 66606

  • Urological Associates of Southern Arizona

    Tucson, Arizona, 85741

Other trials in United States

South Korea5 sites

  • National Cancer Center

    Goyang-si, Gyeonggido, 10408

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyunggido, 13605

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

Other trials in South Korea

About this study

Official title: A Phase I/II Dose-Escalation and Efficacy Study of LAE001/Prednisone Plus Afuresertib in Patients With Metastatic Castration-resistant Prostate Cancer Following Standard of Care Treatment

The combination treatment of protein kinase B (AKT) inhibitor, afuresertib, with androgen synthesis enzyme inhibitor, LAE001, may provide an effective treatment for metastatic castration resistant prostate cancer (m-CRPC) patients who have progressed/drug resistant following prior standard care treatments of any anti-androgen. This study intends to identify the most appropriate combined doses of LAE001/prednisone and afuresertib in m-CRPC patients who have progressive disease or are intolerant of 2 prior standard treatments of any anti-androgen or anti-androgen treatment plus chemotherapy.

Read the detailed description

The Phase I part of this study will perform a dose-escalation to identify the recommended Phase II dose of LAE001/prednisone plus afuresertib in m-CRPC patients.

In the Phase II part of this study, the anti-tumor efficacy of LAE001/prednisone plus afuresertib and docetaxel/prednisone plus afuresertib will be assessed in mCRPC patients with PTEN loss and/or PIK3CA/AKT/PTEN alteration who have progressed on, or who are intolerant of, 1-3 prior standard treatments for mCSPC, or nmCRPC, or mCRPC, including at least one antiandrogen treatment and no more than one chemotherapy. Participants will be assigned to one of the two study cohorts, based on the investigator's clinical judgement. Cohort 1 will receive LAE001/prednisone plus afuresertib using RP2D established in the Phase I study. Cohort 2 will receive docetaxel/prednisone plus afuresertib, with a safety run-in period during the first cycle in the first 6 patients. These study results will provide preliminary efficacy and safety information of the combination of LAE001/prednisone plus afuresertib and docetaxel/prednisone plus afuresertib as requested in the Food and Drug Administration (FDA) combined therapy guideline. Whether to move one or both combination therapies to the pivotal study will be based on the PFS improvements of the combination therapy versus historical controls of abiraterone or docetaxel monotherapies in mCRPC patients who failed 1-3 lines of standard of care therapies.

Being tested
Phase I and Phase II: LAE001/prednisone + afuresertib

What participants receive

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

  • Phase I and Phase II: LAE001/prednisone + afuresertibDrug

    Also called Phase II: Afuresertib

    In the Phase I portion of the study will identify the RPD2 of the combined therapy. In the Phase II will evaluate LAE001/prednisone + afuresertib at the RP2D (Cohort 1) and docetaxel/prednisone + afuresertib (Cohort 2).

Study groups in NCT04060394
Study groupRoleWhat they receive
Phase I Cohort 1ExperimentalLAE001 (capsules) 75mg Twice Daily (BID) + prednisone (tablet) 5mg BID +afuresertib (tablet) 100mg Once Daily (QD) will be administered in Cycles of 28 days.
Receives: Drug: Phase I and Phase II: LAE001/prednisone + afuresertib
Phase I Cohort 2ExperimentalLAE001 (capsules) 100mg BID + prednisone (tablet) 5mg BID +afuresertib (tablet) 100mg QD will be administered in Cycles of 28 days.
Receives: Drug: Phase I and Phase II: LAE001/prednisone + afuresertib
Phase I Cohort 3ExperimentalLAE001 (capsules) 100mg BID + prednisone (tablet) 5mg BID +afuresertib (tablet) 125mg QD will be administered in Cycles of 28 days.
Receives: Drug: Phase I and Phase II: LAE001/prednisone + afuresertib
Phase I Cohort 4ExperimentalLAE001 (capsules) 100mg BID + prednisone (tablet) 5mg BID +afuresertib (tablet) 150mg QD will be administered in Cycles of 28 days.
Receives: Drug: Phase I and Phase II: LAE001/prednisone + afuresertib
Phase II Cohort 1ExperimentalLAE001 (capsules) + prednisone (tablet) +afuresertib at the Recommended Phase II Dose (RP2D)
Receives: Drug: Phase I and Phase II: LAE001/prednisone + afuresertib
Phase II Cohort 2ExperimentalDocetaxel/prednisone + afuresertib
Receives: Drug: Phase I and Phase II: LAE001/prednisone + afuresertib

What is being measured

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

  1. Phase II: Radiological progression free survival (rPFS) based on change in tumor per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

    Based on investigator reviewed radiographic tumor assessment.

    Measured: At the end of each 28 day treatment cycle and within 15 days of last treatment

  2. Phase I: Demonstrate safety and tolerability of LAE001/prednisone and afuresertib as combination therapy.

    Frequency and severity of AEs.

    Measured: Through study completion for an average of 12 months

  3. Phase II: Radiological progression free survival (rPFS) based changes per Prostate Cancer Working Group 3 (PCWG3)

    Based on investigator reviewed radiographic tumor assessment.

    Measured: At the end of each 28 day treatment cycle and within 15 days of last treatment

Secondary outcomes (24)

  1. Phase II: Overall Response Rate (ORR) based tumor changes per RECIST 1.1

    Based on investigator reviewed radiographic tumor assessments and death from any cause.

    Measured: At the end of each 28 day treatment cycle and within 15 days of last treatment

  2. Phase II: Overall Response Rate (ORR) based tumor changes per PCWG3

    Based on investigator reviewed radiographic tumor assessments and death from any cause.

    Measured: At the end of each 28 day treatment cycle and within 15 days of last treatment

  3. Phase II: Duration of Response (DOR) based on tumor changes per RECIST 1.1

    Based on investigator reviewed radiographic tumor assessment and death.

    Measured: At the end of each 28 day treatment cycle and within 15 days of last treatment

  4. Phase I: Duration of Response (DOR) based on tumor changes per RECIST 1.1

    Based on investigator reviewed radiographic tumor assessment and death.

    Measured: At the end of the 28 day treatment cycle for cycles 2,4 and 6 and then every 3 cycles after cycle 6 and within 15 days of last treatment

  5. Phase II: Duration of Response (DOR) based on tumor changes per PCWG3

    Based on investigator reviewed radiographic tumor assessment and death.

    Measured: At the end of each 28 day treatment cycle and within 15 days of last treatment

  6. Phase I: Duration of Response (DOR) based on tumor changes per PCWG3

    Based on investigator reviewed radiographic tumor assessment and death.

    Measured: At the end of the 28 day treatment cycle for cycles 2,4 and 6 and then every 3 cycles after cycle 6 and within 15 days of last treatment

  7. Phase II: Disease Control Rate (DCR) based on tumor changes per RECIST 1.1

    Based on investigator reviewed radiographic tumor assessment and death.

    Measured: At the end of each 28 day treatment cycle and within 15 days of last treatment

  8. Phase II: Disease Control Rate (DCR) based on tumor changes per PCWG3

    Based on investigator reviewed radiographic tumor assessment and death.

    Measured: At the end of each 28 day treatment cycle and within 15 days of last treatment

  9. Phase II: Overall Survival (OS)

    Based on investigator reviewed radiographic tumor assessment and death.

    Measured: At the end of each 28 day treatment cycle and within 15 days of last treatment

  10. Phase II: Changes in Prostate Specific Antigen (PSA) levels

    Analysis of blood samples to be drawn at baseline and end of treatment

    Measured: End of Treatment as compared to baseline

  11. Phase I: Changes in Prostate Specific Antigen (PSA) levels

    Analysis of blood samples to be drawn at baseline and end of treatment

    Measured: Day 1 Cycle 2 (each cycle is 28 days) and all subsequent cycle and End of Treatment for an avergae of 12 months as compared to baseline

  12. Phase II: PSA response

    A >/=50% reduction in PSA from baseline

    Measured: 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

  13. Phase I: PSA response

    A >/=50% reduction in PSA from baseline

    Measured: 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

  14. Phase I: Secondary PSA response

    A >/=30% reduction

    Measured: Baseline to>/=12 weeks after study treatment; confirmed 4 weeks later

  15. Phase II: Best PSA response

    According to PCWG3

    Measured: Through study completion for an avergae of 12 months

  16. Phase I: Best PSA response

    According to PCWG3

    Measured: Through study completion for an average of 12 months

  17. Phase II: Time to PSA progression

    According to PCWG3

    Measured: Through study completion for an average of 12 months

  18. Phase I: Time to PSA progression

    According to PCWG3

    Measured: Through study completion for an average of 12 months

  19. Phase II: % patients with PSA progression or death from any cause

    Patients with PSA progression or have died 12 weeks after treatment

    Measured: At 12 weeks from start of study treatment

  20. Phase II: Frequency and severity of AEs

    Findings on physical examination, ECGs, vital signs and laboratory results based on CTCAE v5.0

    Measured: Through study completion for an average of 12 months

  21. Phase I: Evaluate PK characteristics of study drug in combination treatment

    Assess PK parameters as various timepoints

    Measured: Cycle 1 (each cycle is 28 days) Day 1 and Cycle 1 Day 15

  22. Phase I: Describe pharmacodynamics of study drugs

    Based on changes in blood levels on adrenal hormone and testosterone levels

    Measured: Cycle 1 (each cycle is 28 days) Days 1,8,15 and 22 and Day 1 of subsequent cycles

  23. Phase I: Radiographic tumor response based on Prostate Cancer Working Group 3 (PCWG3)

    Based on investigator reviewed radiographic tumor assessment.

    Measured: At the end of each 28 day treatment cycle for cycles 2,4 and 6 and then every 3 cycles after cycle 6 and within 15 days of last treatment

  24. Phase I: Radiographic tumor response based on RECIST 1.1

    Based on investigator reviewed radiographic tumor assessment.

    Measured: At the end of each 28 day treatment cycle for cycles 2,4 and 6 and then every 3 cycles after cycle 6 and within 15 days of last treatment

Timeline

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

  1. First posted19 Aug 2019
  2. Study start13 Sep 2019
  3. Primary completion27 Dec 2023
  4. Study completion30 Mar 2024

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
Phase 1 Dose Escalation to determine Recommended Phase II Dose (RP2D) of LAE001/Prednisone plus Afuresertib in m-CRPC patients. Once RP2D is determined, Phase II will evaluate LAE001/Prednisone plus Afuresertib vs and Docetaxel/Prednisone plus Afuresertib in m-CRPC patients.
Masking
None (open label)
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04060394
Sponsor's protocol ID
LAE201INT2101
Status last verified
Oct 2024
First submitted
1 Jul 2019
Last updated
10 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Phase I and Phase II: LAE001/prednisone + afuresertib in people with Metastatic Castration-resistant Prostate Cancer, run by Laekna Limited at 17 sites in 2 countries.

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 33 inclusion and 31 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: finished, as of the sponsor's last update on 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States, South Korea. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase II: Radiological progression free survival (rPFS) based on change in tumor per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (time frame: At the end of each 28 day treatment cycle and within 15 days of last treatment). The study lists 3 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 NCT04060394.

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 10 Oct 2024.

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