A Phase Ib/II Study of the Combination of BYL719 Plus AMG 479 in Adult Patients With Selected Solid Tumors
18 Years
N/A
Both
PIK3CA Mutated Advanced Solid Tumors,, PIK3CA Amplified Advanced Solid Tumors
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:
Interventional
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:
Yes
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
CBYL719X2105J
NCT ID:
NCT01708161
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
Name | Location |
|---|---|
| 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 |
