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

Phase 1/Phase 2
18 Years
Open (Enrolling)
PIK3CA Mutated Advanced Solid Tumors,, PIK3CA Amplified Advanced Solid Tumors

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Trial Information

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

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. The dose escalation part of the study will be guided by a Bayesian Logistic
Regression Model (BLRM).

Once MTD/RP2D has been determined, patients will be enrolled in two Phase II arms. Patients
with PIK3CA mutated or amplified hormone receptor positive breast carcinoma will be enrolled
in Arm 1; patients with PIK3CA mutated or amplified ovarian carcinoma will be enrolled in
Arm 2. 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. In addition, patients who have not progressed at
the time of discontinuation of study treatment should have radiological follow-up for the
disease status and phase II patients will be followed for survival.

Inclusion 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of dose limiting toxicities (DLTs)

Outcome Description:

Phase lb only

Outcome Time Frame:

Cycle 1 (initial 28 days of treatment)

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

November 2012

Completion Date:

November 2015

Related Keywords:

  • PIK3CA Mutated Advanced Solid Tumors,
  • PIK3CA Amplified Advanced Solid Tumors
  • PIK3CA mutation, advanced solid tumor, breast cancer, ovarian cancer
  • Neoplasms



Massachusetts General Hospital Mass General 2 Boston, Massachusetts  02114
University of California at Los Angeles TORI Los Angeles, California  90095
Memorial Sloan Kettering Cancer Center MSKCC 5 New York, New York  10021
Sarah Cannon Research Institute SCRI 3 Nashville, Tennessee  37203