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 being studied for third-line gastrointestinal stromal tumor (GIST), meaning GIST that has progressed after prior lines of therapy. It is an oncology combination regimen developed by Novartis and has been tested in a single Phase 1 dose-finding study in adults with third-line GIST.
ST571+ BYL719 is developed by Novartis AG, which trades under the ticker NVS. Novartis sponsored the Phase 1 dose-finding study of the combination in third-line GIST patients across sites in the United States and several European countries.
ST571+ BYL719 is in Phase 1 development. It has been evaluated in one completed Phase 1 dose-finding trial in third-line GIST, and no later-stage trials of the combination have been recorded. It is an investigational regimen and is not an approved therapy.
ST571+ BYL719 was studied in NCT01735968, a Phase 1 dose-finding trial of a combination of imatinib and BYL719 in third-line GIST patients. The trial enrolled 56 adults, was uncontrolled and non-randomized, and is now completed, with sites in the United States, Belgium, France, Germany, Italy, the Netherlands, Spain, and the United Kingdom.