Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ST571+ BYL719 · 1 trial · 1 indication
Dose limiting toxicity (DLT) will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) (v4.0.3), unless otherwise specified in the protocol.
Dose limiting toxicity (DLT) will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) (v4.0.3), unless otherwise specified in the protocol.
| Arm | Type | Description |
|---|---|---|
| STI571 (imatinib mesylate) and BYL719 | EXPERIMENTAL | The study will comprise of 2 parts. A dose escalation and a dose expansion part. All patients in the dose escalation part will have a pharmacokinetic (PK) run-in period of 7 days receiving imatinib monotherapy. Patients will receive increasing doses of BYL719 (200, 300, 400 mg) in combination with 400mg imatinib daily until maximum tolerated dose (MTD) and rapid phase 2 dose (RP2D) is determined. Approximately 35 patients will enter the expansion phase. |
| Name | Type | Description |
|---|---|---|
| ST571 + BYL719 | DRUG | Evaluable patients must meet the minimum treatment and safety evaluation requirements of the study. Patients will be treated until they experience progression of disease, withdraw consent, or experience unacceptable toxicity. One study cycle equals 28 days. |
Inclusion Criteria: * Male or female patients ≥ 18 years of age -WHO performance status (PS) of 0-2 -Histologically confirmed diagnosis of GIST that is unresectable or metastatic -.Available tissue specimen: • Dose-escalation part: patients must have available archival tumor tissue which can be shi...
ST571+ BYL719 is an investigational combination therapy being studied for the treatment of 3rd line gastrointestinal stromal tumors (GIST). It is a small molecule oncology treatment developed by Novartis AG. The combination is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
ST571+ BYL719 is a combination of two small molecules: imatinib (ST571), which targets BCR-ABL and KIT tyrosine kinases, and BYL719 (alpelisib), which targets PI3K alpha. This dual targeting approach is being investigated for its potential efficacy in 3rd line GIST patients.
ST571+ BYL719 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. Novartis is conducting clinical trials to evaluate the safety and efficacy of this combination therapy in patients with 3rd line gastrointestinal stromal tumors.
ST571+ BYL719 is currently in Phase 1 clinical development. The therapy is investigational and has not been approved by the FDA or any other regulatory agency. It is being studied in a completed Phase 1 trial for the treatment of 3rd line GIST, with results yet to be reported.
ST571+ BYL719 has been studied in one clinical trial, NCT01735968, titled "A Dose-finding Study of a Combination of Imatinib and BYL719 in the Treatment of 3rd Line GIST Patients." This Phase 1, uncontrolled, non-randomized trial enrolled 56 participants across multiple countries including the United States, Belgium, France, Germany, Italy, Netherlands, Spain, and the United Kingdom. The trial has been completed.
ST571+ BYL719 is a combination therapy consisting of two drugs: ST571, which is imatinib, and BYL719, which is alpelisib. These are separate small molecule agents that are combined in this investigational regimen for the treatment of 3rd line GIST. The combination is being developed by Novartis AG.