PIK3CA Amplified Advanced Solid Tumors Clinical Trial
Official title:
A Phase Ib/II Study of the Combination of BYL719 Plus AMG 479 in Adult Patients With Selected Solid Tumors
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.
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. The dose escalation part of the study were to be guided by a Bayesian Logistic
Regression Model (BLRM).
Once MTD/RP2D had been determined, patients were to be enrolled in two Phase II arms.
Patients with PIK3CA mutated or amplified hormone receptor positive breast carcinoma were to
be enrolled in Arm 1; patients with PIK3CA mutated or amplified ovarian carcinoma were to be
enrolled in Arm 2. 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.
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