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: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Collaborator: NantCell, Inc.
• Treatments: Antibodies, Monoclonal

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.