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



Status:Terminated
Healthy:No
Age Range:18 - Any
Updated:9/15/2018
Start Date:November 27, 2012
End Date:June 1, 2017

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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.

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.
We found this trial at
5
sites
Boston, Massachusetts 02118
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Leuven,
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Los Angeles, California 90095
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Los Angeles, CA
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Nashville, Tennessee 37205
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Nashville, TN
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230 Park Avenue, 21st Floor
New York, New York 10169
1-888-669-6682)
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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New York, NY
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