Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Afuresertib · 1 trial · 1 indication
An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect
Clinical laboratory tests included hematology, clinical chemistry, urinalysis
Heart rate, pulse rate (PR), QRS, QT, and Electrocardiogram QT interval corrected for heart rate using Fridericia's formula (QTcF intervals) will be recorded by measuring triplicate 12-lead ECGs, obtained in semi-recumbent or supine position after 5 minutes rest
The cardiac ejection fraction and cardiac valve morphology will be assessed by ECHOs. The evaluation of the echocardiographer should include an evaluation for left ventricular ejection fraction (LVEF)
Vital signs will include measurement of systolic and diastolic blood pressure. Vital signs should be measured after resting for at least 5minutes in a semi-supine position
Tumor response will be measured by Response Evaluation Criteria In Solid Tumors (RECIST 1.1), the ORR will be based on confirmed responses by investigator-based assessment for gastric cancer
Vital signs will include measurement of respiration rate. Vital signs should be measured after resting for at least 5minutes in a semi-supine position.
Vital signs will include measurement of PR. Vital signs should be measured after resting for at least 5minutes in a semi-supine position.
| Arm | Type | Description |
|---|---|---|
| Part 1: Dose-escalation (weekly paclitaxel) | EXPERIMENTAL | The dose escalation will be started from Cohort A (afuresertib combined with weekly paclitaxel regimen at 80 mg/m\^2 d1, 8,15, q4w). The starting dose in Cohort A will be 125 mg afuresertib QD to indentify MTD |
| Part 1: Dose-escalation (3 weeks Paclitaxel) | EXPERIMENTAL | Once its MTD is identified, and then the study will move to dosing Cohort B (afuresertib combined with 3 weekly paclitaxel regimen at 175 mg/m\^2 d1, q3w. Cohort B (afuresertib combined with 3 weekly paclitaxel regimen at 175 mg/m\^2 d1, q3w). The starting daily dose of Cohort B will be 25 mg less than the MTD dose from Cohort A for afuresertib. If it is tolerated, then the dose escalation schedule will be followed in Cohort B until the MTD in this Cohort is reached. If the starting dose is not tolerated, then dose de-escalation will be explored until the MTD in this Cohort is reached. Once two dimensions of the MTD are achieved, then the optimal regimen for paclitaxel and MTD for afuresertib combined with paclitaxel based on the toxicity profile will be identified |
| Part 2: Experimental Cohort | EXPERIMENTAL | The optimal regimen for paclitaxel and MTD for afuresertib combined with paclitaxel based on the toxicity profile will be administered |
| Name | Type | Description |
|---|---|---|
| Afuresertib | DRUG | The unit dose strength is 50mg/75mg tablet. Afuresertib will be taken orally once daily continuously during trail. |
| Paclitaxel | DRUG | Paclitaxel sourced locally will be administered IV |
Inclusion Criteria: * Provided signed written informed consent * Male or female \>=18 years of age with a diagnosis of Performance Status score of 0 or 1 according to the Eastern Cooperative Oncology at the time of signing the informed consent * Able to swallow and retain orally administered study ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520/ GEH200521- Part A |
| Zimmer Biomet Holdings, Inc. | ZBH | 1 | - | Undisclosed |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |
Afuresertib is an investigational small molecule being studied for the treatment of cancer. It has been evaluated in a Phase 1 clinical trial in combination with paclitaxel in patients with gastric cancer. The drug is not approved and remains in clinical development.
Afuresertib is being developed by Novartis AG, which trades on the New York Stock Exchange under the ticker NVS. The company is conducting clinical research to evaluate the drug's safety and efficacy in cancer patients.
Afuresertib is in Phase 1 clinical development. A Phase 1 study of the drug combined with paclitaxel in gastric cancer has been completed. The drug is investigational and has not been approved by regulatory authorities.
Afuresertib has been studied in one clinical trial, registered as NCT02240212, titled 'Study of Afuresertib Combined With Paclitaxel in Gastric Cancer.' This Phase 1 trial enrolled 29 participants in South Korea and Taiwan and has been completed.
Afuresertib is also known by the name GSK2110183. It is a small molecule being developed by Novartis AG for cancer treatment. The drug has been tested in a Phase 1 trial for gastric cancer.