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GSK2110183 · 2 trials · 2 indications
Adverse Events (AEs) includes Summary of adverse events, drug related AEs, Serious adverse events, adverse events leading to study treatment discontinuation and death.
Dose and schedule determined using adverse events and changes in safety assessments (laboratory parameters, vital signs and ECG parameters). Recommended Phase 2 Dose (RP2D) will be defined in Part 1. The specific number of subjects to be enrolled is dependent on the number of dose limiting toxicities (DLTs) reported; enrollment of up to 45 subjects in Part 1 is estimated. Subjects will continue on study from the date of randomization until the date of the first documented disease progression or when the subject meets one of the Treatment Discontinuation criteria, whichever comes first
| Arm | Type | Description |
|---|---|---|
| GSK2110183 (afuresertib) | EXPERIMENTAL | All patients received the GSK2110183 (afuresertib) treatment |
| Part 1-Dose Escalation | EXPERIMENTAL | GSK2110183 is administered in combination with bortezomib and dexamethasone until MTD is met. |
| Part 2- Pharmacokinetic/Pharmacodynamics Cohort | EXPERIMENTAL | Once the MTD(s) has been determined, up to 9 subjects of the total enrolled in Part 2 will be entered in the Pharmacokinetic/Pharmacodynamic Cohort. Subjects will be enrolled in this cohort to explore whether exposure to GSK2110183 at dose identified in Part 1 is similar when GSK2110183 is administered alone or in combination with bortezomib and dexamethasone. The same relationship will be explored for bortezomib and dexamethasone when the two drugs are give alone or in combination with GSK2110183. |
| Part 2- Safety/Clinical Activity Cohort | EXPERIMENTAL | Enrolment into the safety/clinical activity cohort in Part 2 will begin prior to enrollment in the PK/PD cohort. Subjects with relapsed multiple myeloma who are either bortezomib sensitive or naive after failing one line of prior systemic therapy will be enrolled in the Safety/Clinical Activity cohort. "Bortezomib sensitive" is defined as having a response (PR or better) to the last bortezomib-containing therapy lasting at least 60 days beyond the end of therapy. A minimum of 15 subjects and a total of 40 subjects will be enrolled. This expansion cohort will further characterize the safety and clinical activity profile of GSK2110183 to inform the future development of this combination regimen. |
| Name | Type | Description |
|---|---|---|
| GSK2110183 (afuresertib) | DRUG | Afuresertib is an oral, low nanomolar pan-AKT kinase inhibitor immediate release (IR) 50 mg or 75 mg tablets was to be taken orally with at least 200 mL of water, with or without food, in the morning. |
| GSK2110183 | DRUG | The oral, once daily dose of GSK2110183 will be dependent on the cohort to which a subject is assigned. Subjects enrolled in Cohort 1 will receive 75 mg GSK2110183 once daily. Dose escalation in Schedule A and Schedule B will follow 25 mg increments in a 3+3 dose escalation procedure up to a maximum of 150mg daily or until MTD is reached, whichever comes first, for each schedule. GSK2110183 will continue at daily dosing until treatment discontinuation criteria is met. |
| Bortezomib | DRUG | Bortezomib (1.0 mg/m2) will be administered on days 1, 4, 8, and 11 of each 21-day cycle for cohort 1 for up to 8 cycles. Bortezomib (1.3 mg/m2) will be administered on days 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Bortezomib (1.5 mg/m2) will be administered on days 1, 8, and 15 of each 21-day cycle for up to 8 cycles. |
| Dexamethasone | DRUG | Dexamethasone will be given orally at a fixed dose of 20 mg only on days of bortezomib dosing in both Schedule A and Schedule B. |
Inclusion Criteria: * Has provided signed informed consent for this study. * Is currently participating in a GSK2110183 study (monotherapy or in combination with an approved anti-cancer agent) sponsored by GSK or by another research organization working on behalf of GSK. * Currently benefitting fro...
| 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 |
GSK2110183 is an investigational small molecule being studied for the treatment of cancer, including multiple myeloma. It is currently in Phase 2 clinical development and is not approved by the FDA. The drug is being developed by Novartis AG.
GSK2110183 is an oral AKT inhibitor. It works by targeting the AKT protein, which is part of a signaling pathway involved in cell growth and survival. By inhibiting AKT, the drug aims to disrupt cancer cell proliferation.
GSK2110183 is being developed by Novartis AG, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The drug is currently in Phase 2 clinical trials for cancer and multiple myeloma.
GSK2110183 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The drug is being studied for the treatment of cancer and multiple myeloma, with one completed Phase 1 trial and one completed Phase 2 trial.
GSK2110183 has been studied in two clinical trials. NCT01428492 was a Phase 1 study evaluating the drug in combination with bortezomib and dexamethasone in patients with multiple myeloma, enrolling 90 participants. NCT01531894 was a Phase 2 continuation study in cancer patients, enrolling 11 participants. Both trials are completed.
Yes, GSK2110183 is an oral AKT inhibitor. It is designed to block the activity of AKT, a protein kinase that plays a role in cell survival and growth. This mechanism is being investigated as a potential treatment for cancer and multiple myeloma.