A Phase Ib/II Study of the Combination of BYL719 Plus AMG 479 in Adult Patients With Selected Solid Tumors

Status: Recruiting
Phase: Phase 1/Phase 2
Diagnosis: Solid Tumor/Phase I
NCT ID: NCT01708161 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-121


This is a multi-center, open-label, phase Ib/II study. The aim of the phase Ib part is 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 will be treated until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurs first. All patients will be followed up. At a minimum, patients must complete the safety follow-up assessments 30 days after the last dose of the study treatment.


Conducting Institutions:
Massachusetts General Hospital, Dana-Farber Cancer Institute, Brigham and Women's Hospital

Overall PI:
Dejan Juric, MD, Massachusetts General Hospital

Site-responsible Investigators:
Geoffrey Shapiro, MD, PhD, Dana-Farber Cancer Institute

Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Dana-Farber Cancer Institute: Andrew Wolanski, 617-632-6623, andrew_wolanski@dfci.harvard.edu

Eligibility Criteria

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 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. Other protocol-defined inclusion/exclusion criteria may apply.
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