Breast Cancer Clinical Trial
A Phase Ib/II Study of the Combination of BYL719 Plus AMG 479 in Adult Patients With Selected Solid Tumors
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.
Full Description
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.
Eligibility Criteria
Key inclusion criteria:
Written informed consent.
Patients aged ≥ 18 years (male or female).
Patients with the following histologically/cytologically-confirmed advanced solid tumors with documented somatic PIK3CA mutations or amplifications in tumor tissue:
Hormone receptor positive breast carcinoma
Ovarian carcinoma
Other tumors upon agreement with sponsor
Adequate organ function
Negative serum pregnancy test
Key exclusion criteria:
Patients with known history of severe infusion reactions to monoclonal antibodies.
Patients with primary CNS tumor or CNS tumor involvement.
History of thromboembolic event requiring full-dose anti-coagulation therapy any time prior to enrollment.
Clinically significant cardiac disease.
History of another malignancy within last 2 years.
Pregnant or nursing (lactating) women.
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There are 10 Locations for this study
Los Angeles California, 90095, United States
Boston Massachusetts, 02114, United States
New York New York, 10017, United States
Nashville Tennessee, 37203, United States
Leuven , 3000, Belgium
Toronto Ontario, M5G 1, Canada
Sevilla Andalucia, 41013, Spain
Barcelona Catalunya, 08035, Spain
Madrid , 28033, Spain
Madrid , 28041, Spain
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