A Phase Ib/II Study of the Combination of BYL719 Plus AMG 479 in Adult Patients With Selected Solid Tumors
Stopped early · Phase 1/Phase 2
Conditions studied: PIK3CA Mutated Advanced Solid Tumors, PIK3CA Amplified Advanced Solid Tumors
In brief
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.
Key facts
- Study ID
- NCT01708161
- Run by
- Novartis Pharmaceuticals
- People needed
- 47
- Starts
- 2012-11-27
- Expected to finish
- 2017-06-01
- Last updated by the study team
- 2018-09-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Novartis Investigative Site — Los Angeles, California, United States
- Novartis Investigative Site — Boston, Massachusetts, United States
- Novartis Investigative Site — New York, New York, United States
- Novartis Investigative Site — Nashville, Tennessee, United States
- Novartis Investigative Site — Leuven, Belgium
- Novartis Investigative Site — Toronto, Ontario, Canada
- Novartis Investigative Site — Seville, Andalusia, Spain
- Novartis Investigative Site — Barcelona, Catalonia, Spain
- Novartis Investigative Site — Madrid, Spain
- Novartis Investigative Site — Madrid, Spain
Full record on ClinicalTrials.gov
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