A Phase Ib/II Study of the Combination of BYL719 Plus AMG 479 in Adult Patients With Selected Solid Tumors
Status:
Terminated
Trial end date:
2017-06-01
Target enrollment:
Participant gender:
Summary
This was a multi-center, open-label, phase Ib/II study. The aim of the phase Ib part was to
estimate the MTD(s) and/or identify the recommended phase II dose(s) (RP2Ds) for the
combination of BYL719 and AMG 479 (ganitumab), followed by the phase II part to assess the
clinical efficacy and to further assess the safety of the combination in selected patient
populations. Patients were to be treated until progression of disease, unacceptable toxicity
develops, or withdrawal of informed consent, whichever occurred first. All patients were to
be followed up. At a minimum, patients must have completed the safety follow-up assessments
30 days after the last dose of the study treatment.