A Phase 2 interventional study of Paclitaxel and Afuresertib in Platinum-resistant Ovarian Cancer, sponsored by Laekna Limited. Completed at 47 sites in 2 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Laekna Limited · Phase 2, Interventional, and Treatment
Afuresertib is an AKT inhibitor, a new class of agents under development that may provide physicians with a new clinical option to control platinum resistant ovarian cancer (PROC) progression. Afuresertib plus chemotherapy has demonstrated anti-tumor efficacy and an acceptable safety profile in patients with PROC in a published Phase I/II study. Therefore, the combination of afuresertib plus weekly paclitaxel could represent a clinically meaningful step forward in the clinical management of these difficult-to-treat patients with PROC.
A total of approximately 141 patients with PROC are planned to be enrolled and randomized with a 2:1 ratio in an open label manner to the 2 arms (94 patients in the combination treatment arm and 47 patients in the paclitaxel arm) for efficacy and safety evaluation. The randomization will be stratified by country (the United States vs. China), prior bevacizumab use (yes vs. no), and number of prior platinum based therapy treatments (1-2 vs. 3-5 prior platinum regimens). The study will consist of 3 periods. The first period is the Screening Period (Day -24 to 1) during which patients are screened for eligibility according to the inclusion and exclusion criteria. The second period is a Treatment Evaluation Period with a randomized, open-label, two arm parallel design (from starting study treatment until patients have progressive disease [PD], unacceptable toxicity, death, or withdrawal of consent). The PK study will be applied to both the combination treatment arm and control arm. The third period is a Follow up Period (safety evaluation at 30 days after the last dose of study treatment and OS and/or PFS follow up). Patients will be tested at baseline for phosphoinositide 3 kinase (PI3K)/AKT/PTEN pathway alterations and BRCA1/2 mutations by NGS, and/or level of phospho AKT by IHC; the correlation of the efficacy endpoints and biomarker status will be analyzed retrospectively as an exploratory endpoint.
3,381 studies on the registry are indexed under Ovarian Neoplasms; 790 are open to participants now.
This study's enrollment of 150 is above the median of 54 across 2,548 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Laekna Limited is the lead sponsor of 11 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Must meet the following criteria for hematology parameters:
Exclusion Criteria:
(HIV)-positive patients with 1 or more of the following:
Patients with active (positive hepatitis B surface antigen [HBsAg] test at screening) or (positive hepatitis C virus [HCV] antibody test at screening) are not allowed to be enrolled in this study. Note:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Arm 1 is afuresertib 125 mg PO QD + paclitaxel 80 mg/m2 intravenous (IV) infusion over 1 hour on Days 1, 8 and 15 of a 3 week cycle.
Drug: Paclitaxel · Drug: Afuresertib
Arm 2 is paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15 of a 3 week cycle
Drug: Paclitaxel
Commercially available paclitaxel for IV administration will be obtained by clinical sites in US.
Afuresertib tablet, intended for daily oral administration.
Also known as: LAE002
Progression-free Survival(PFS ) Based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Radiographic imaging will be performed and assessed by investigators to evaluate the duration of progress-free survival(PFS) based on RECIST 1.1
Time frame: From first dose, evaluate every 6 weeks × 30 weeks, then change to every 8 weeks until study completion, assessed up to 40 months. Progress-free survival (PFS) is defined as from randomization to disease progression or death due to any reason
Objective Response Rate (ORR) According to RECIST 1.1
To further evaluate the clinical efficacy via objective response rate
Time frame: The percentage of objective response achieved, objective response is from randomization to either complete response (CR) or partial response (PR) . Evaluate every 6 weeks × 30 weeks, then change to every 8 weeks, up to 40 months
Duration of Response (DOR) According to RECIST 1.1
To further evaluate the clinical efficacy via duration of response
Time frame: Evaluate every 6 weeks × 30 weeks, change to every 8 weeks, up to 40 months. DOR is from first observation of response (complete response (CR) or partial response( PR)) until first observation of disease progression or death, whichever occurs first.
Disease Control Rate (DCR) According to RECIST 1.1
To further evaluate the clinical efficacy via Disease control rate
Time frame: the percentage of participant who have achieved complete response(CR), partial response (PR) or stable disease(SD) from first study treatment to discontinued study treatment. Evaluate every 6 weeks × 30 weeks, change to every 8 weeks, up to 40 months.
Overall Survival (OS)
To further evaluate the clinical efficacy via OS collection
Time frame: OS is defined from date of randomization until death date for any cause. Evaluated from randomization to study completion which is 105 events, up to 40 months.
Cancer Antigen 125 (CA-125) Response (Gynecological Cancer Intergroup [GCIG])
To further evaluate the clinical efficacy via cancer antigen 125 (CA125) response rate
Time frame: every 6 weeks × 30 weeks from Baseline , then every 8 weeks through study completion of 105 PFS events achievement, up to 40 months
Area Under the Curve in the Inter-dose Interval Period After First Dose (AUCτ)
To Characterize Pharmacokinetics (PK) of afuresertib and paclitaxel in patients with PROC under combination therapy of afuresertib plus paclitaxel at steady-state via AUCτ
Time frame: Samples collected on Cycle1Day1 (a Cycle is 21 days) of pre-dose and at 1h (at the end of paclitaxel infusion), 2h, 3h, 4h, 8h and 24 hours post-dose
Area Under the Curve in the Inter-dose Interval Period at Steady State (AUCτ_SS)
To Characterize Pharmacokinetics (PK) of afuresertib and paclitaxel in patients with PROC under combination therapy of afuresertib plus paclitaxel, or paclitaxel alone at steady-state via AUCτ\_SS
Time frame: sample collection on cycle2 Day 1 (21days in 1 cycle) of pre-dose and at 0.5h, 1h (at the end of paclitaxel infusion), 2h, 3h, 4h, 8h and 24 hours post-dose
Maximum Concentration After First Dose (Cmax)
To Characterize Pharmacokinetics (PK) of afuresertib and paclitaxel in patients with PROC under combination therapy of afuresertib plus paclitaxel at steady-state via Cmax
Time frame: Samples collected on Cycle1Day1 (a Cycle is 21 days) of pre-dose and at 1h (at the end of paclitaxel infusion), 2h, 3h, 4h, 8h and 24 hours post-dose
Maximum Concentration at Steady State (Cmax_SS)
To Characterize Pharmacokinetics (PK) of afuresertib and paclitaxel in patients with PROC under combination therapy of afuresertib plus paclitaxel, or paclitaxel alone at steady-state via Cmax\_SS
Time frame: sample collection on cycle2 Day 1 (21days in 1 cycle) of pre-dose and at 0.5h, 1h (at the end of paclitaxel infusion), 2h, 3h, 4h, 8h and 24 hours post-dose
Time to Maximum Concentration After First Dose (Tmax) To Explore Potential Effect of Coadministration of Afuresertib
To Characterize Pharmacokinetics (PK) of afuresertib in patients with PROC under combination therapy of afuresertib plus paclitaxel at steady-state via Tmax
Time frame: Samples collected on Cycle1Day1 (a Cycle is 21 days) of pre-dose and at 1h (at the end of paclitaxel infusion), 2h, 3h, 4h, 8h and 24 hours post-dose
Time to Maximum Concentration at Steady State (Tmax_SS)
To Characterize Pharmacokinetics (PK) of afuresertib and paclitaxel in patients with PROC under combination therapy of afuresertib plus paclitaxel, or paclitaxel alone at steady-state via Tmax\_SS
Time frame: sample collection on cycle2 Day 1 (21days in 1 cycle) of pre-dose and at 0.5h, 1h (at the end of paclitaxel infusion), 2h, 3h, 4h, 8h and 24 hours post-dose
Trough Concentration at Steady State (Ctrough_SS)
To Characterize Pharmacokinetics (PK) of afuresertib and paclitaxel in patients with PROC under combination therapy of afuresertib plus paclitaxel, or paclitaxel alone at steady state via Ctrough\_SS
Time frame: Samples collected on Cycle2Day1was assessed (a Cycle is 21 days)
Progress-free Survival (PFS) Based on RECIST 1.1
explore the PFS of the combination treatment arm versus paclitaxel arm in association with the biomarkers: o Levels of phospho-AKT in tumor sample as assessed by immunohistochemistry (IHC)
Time frame: After C2 (each cycle is 21 days), then every 6 weeks for 30 weeks, then every 8 weeks through study completion, assessed up to 40 months.
OS
explore the OS of the combination treatment arm versus paclitaxel arm in association with the biomarkers: o Levels of phospho-AKT in tumor sample as assessed by immunohistochemistry (IHC)
Time frame: From date of randomization until date of death for any cause, assessed up to 40 months.
| Milestone | Afuresertib and Paclitaxel | Paclitaxel Only |
|---|---|---|
| Started | 99 | 51 |
| Completed | 94 | 46 |
| Not completed | 5 | 5 |
Radiographic imaging will be performed and assessed by investigators to evaluate the duration of progress-free survival(PFS) based on RECIST 1.1
| month | Afuresertib and Paclitaxel | Paclitaxel Only |
|---|---|---|
| Progression-free Survival(PFS ) Based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 | 4.3 (3.58 to 5.62) | 4.1 (2.63 to 5.36) |
To further evaluate the clinical efficacy via objective response rate
| Participants | Afuresertib and Paclitaxel | Paclitaxel Only |
|---|---|---|
| Objective Response Rate (ORR) According to RECIST 1.1 | 25 (17.06% to 34.98%) | 9 (8.4% to 30.87%) |
To further evaluate the clinical efficacy via duration of response
| months | Afuresertib and Paclitaxel | Paclitaxel Only |
|---|---|---|
| Duration of Response (DOR) According to RECIST 1.1 | 6.8 (4.14 to 14.69) | 3.7 (2.56 to 7.2) |
To further evaluate the clinical efficacy via Disease control rate
| Participants | Afuresertib and Paclitaxel | Paclitaxel Only |
|---|---|---|
| Disease Control Rate (DCR) According to RECIST 1.1 | 67 | 29 |
To further evaluate the clinical efficacy via OS collection
| month | Afuresertib and Paclitaxel | Paclitaxel Only |
|---|---|---|
| Overall Survival (OS) | 11.2 (8.38 to 13.77) | 13.1 (7.75 to 18.00) |
To further evaluate the clinical efficacy via cancer antigen 125 (CA125) response rate
| Participants | Afuresertib and Paclitaxel | Paclitaxel Only |
|---|---|---|
| Cancer Antigen 125 (CA-125) Response (Gynecological Cancer Intergroup [GCIG]) | 19 | 9 |
To Characterize Pharmacokinetics (PK) of afuresertib and paclitaxel in patients with PROC under combination therapy of afuresertib plus paclitaxel at steady-state via AUCτ
| h*ng/ml | Afuresertib and Paclitaxel | Paclitaxel Only |
|---|---|---|
| Area Under the Curve in the Inter-dose Interval Period After First Dose (AUCτ) | 3370 ± 47.9 | — |
To Characterize Pharmacokinetics (PK) of afuresertib and paclitaxel in patients with PROC under combination therapy of afuresertib plus paclitaxel, or paclitaxel alone at steady-state via AUCτ\_SS
| h*ng/ml | Afuresertib and Paclitaxel | Paclitaxel Only |
|---|---|---|
| Area Under the Curve in the Inter-dose Interval Period at Steady State (AUCτ_SS) | 5100 ± 2.51 | 4450 ± 1.33 |
To Characterize Pharmacokinetics (PK) of afuresertib and paclitaxel in patients with PROC under combination therapy of afuresertib plus paclitaxel at steady-state via Cmax
| ng/ml | Afuresertib and Paclitaxel | Paclitaxel Only |
|---|---|---|
| Maximum Concentration After First Dose (Cmax) | 264.68 ± 53 | — |
To Characterize Pharmacokinetics (PK) of afuresertib and paclitaxel in patients with PROC under combination therapy of afuresertib plus paclitaxel, or paclitaxel alone at steady-state via Cmax\_SS
| ng/ml | Afuresertib and Paclitaxel | Paclitaxel Only |
|---|---|---|
| Maximum Concentration at Steady State (Cmax_SS) | 625.7 ± 1.76 | 2342.7 ± 1.71 |
To Characterize Pharmacokinetics (PK) of afuresertib in patients with PROC under combination therapy of afuresertib plus paclitaxel at steady-state via Tmax
| h | Afuresertib and Paclitaxel | Paclitaxel Only |
|---|---|---|
| Time to Maximum Concentration After First Dose (Tmax) To Explore Potential Effect of Coadministration of Afuresertib | 3 (1.15 to 24) | — |
To Characterize Pharmacokinetics (PK) of afuresertib and paclitaxel in patients with PROC under combination therapy of afuresertib plus paclitaxel, or paclitaxel alone at steady-state via Tmax\_SS
| h | Afuresertib and Paclitaxel | Paclitaxel Only |
|---|---|---|
| Time to Maximum Concentration at Steady State (Tmax_SS) | 3.05 (0.5 to 8.12) | 1.05 (0.5 to 1.82) |
explore the PFS of the combination treatment arm versus paclitaxel arm in association with the biomarkers: o Levels of phospho-AKT in tumor sample as assessed by immunohistochemistry (IHC)
| months | Afuresertib and Paclitaxel | Paclitaxel Only |
|---|---|---|
| Progress-free Survival (PFS) Based on RECIST 1.1 | 5.4 (3.4 to 6.4) | 2.9 (1.3 to NA) |
explore the OS of the combination treatment arm versus paclitaxel arm in association with the biomarkers: o Levels of phospho-AKT in tumor sample as assessed by immunohistochemistry (IHC)
| months | Afuresertib and Paclitaxel | Paclitaxel Only |
|---|---|---|
| OS | 9.5 (6.1 to 12.0) | 9.0 (3.1 to 15.3) |
To Characterize Pharmacokinetics (PK) of afuresertib and paclitaxel in patients with PROC under combination therapy of afuresertib plus paclitaxel, or paclitaxel alone at steady state via Ctrough\_SS
| ng/ml | Afuresertib and Paclitaxel | Paclitaxel Only |
|---|---|---|
| Trough Concentration at Steady State (Ctrough_SS) | 329.49 ± 215.824 | 0 ± 0 |
Collected over AEs were collected from first participant first visit until 30 days following discontinuation of study treatment, up to 40 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Afuresertib and Paclitaxel | 66/99 (66.7%) | 34/99 (34.3%) | 98/99 (99%) |
| Paclitaxel Only | 27/47 (57.4%) | 12/47 (25.5%) | 46/47 (97.9%) |
| Event | Afuresertib and Paclitaxel | Paclitaxel Only |
|---|---|---|
| Small intestinal obstructionGastrointestinal disorders | 2/99 | 2/47 |
| Neutrophil count decreasedInvestigations | 4/99 | 0/47 |
| AnaemiaBlood and lymphatic system disorders | 3/99 | 0/47 |
| Enterocolitis infectiousInfections and infestations | 3/99 | 0/47 |
| SepsisInfections and infestations | 3/99 | 0/47 |
| Intestinal obstructionGastrointestinal disorders | 1/99 | 1/47 |
| Small intestinal perforationGastrointestinal disorders | 0/99 | 1/47 |
| Chest painGeneral disorders | 0/99 | 1/47 |
| COVID-19Infections and infestations | 2/99 | 1/47 |
| PneumoniaInfections and infestations | 1/99 | 1/47 |
| Event | Afuresertib and Paclitaxel | Paclitaxel Only |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 64/99 | 9/47 |
| AnaemiaBlood and lymphatic system disorders | 53/99 | 21/47 |
| Neutrophil count decreasedInvestigations | 50/99 | 24/47 |
| FatigueGeneral disorders | 45/99 | 18/47 |
| White blood cell count decreasedInvestigations | 40/99 | 21/47 |
| NauseaGastrointestinal disorders | 32/99 | 14/47 |
| AlopeciaSkin and subcutaneous tissue disorders | 22/99 | 14/47 |
| HyperglycaemiaMetabolism and nutrition disorders | 26/99 | 1/47 |
| ConstipationGastrointestinal disorders | 17/99 | 11/47 |
| HypokalaemiaMetabolism and nutrition disorders | 19/99 | 4/47 |
| Age, Customized(years) | Afuresertib and Paclitaxel | Paclitaxel Only | Total |
|---|---|---|---|
| age at screening/years | 62 (40 to 89) | 61 (38 to 80) | 61 (38 to 89) |
| Sex: Female, Male(Participants) | Afuresertib and Paclitaxel | Paclitaxel Only | Total |
|---|---|---|---|
| Female | 99 | 51 | 150 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Afuresertib and Paclitaxel | Paclitaxel Only | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 47 | 25 | 72 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 1 | 1 | 2 |
| White | 48 | 20 | 68 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 4 | 6 |
| Ethnicity (NIH/OMB)(Participants) | Afuresertib and Paclitaxel | Paclitaxel Only | Total |
|---|---|---|---|
| Hispanic or Latino | 5 | 2 | 7 |
| Not Hispanic or Latino | 94 | 44 | 138 |
| Unknown or Not Reported | 0 | 5 | 5 |
| Region of Enrollment(Participants) | Afuresertib and Paclitaxel | Paclitaxel Only | Total |
|---|---|---|---|
| United States | 54 | 27 | 81 |
| China | 45 | 24 | 69 |
PDFs hosted by the registry, ClinicalTrials.gov.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Afuresertib
Laekna Limited