A Phase I/II, Multicenter, Open-label Study of EGFRmut-TKI EGF816, Administered Orally in Adult Patients With EGFRmut Solid Malignancies
Completed · Phase 1/Phase 2
Conditions studied: Advanced Non-small Cell Lung Cancer
In brief
This is a Phase I/II, multi-center, open-label study, composed with a Phase I part (dose-escalation phase) followed by a Phase II part (expansion phase). The dose escalation phase was designed to determine as primary objective the maximum tolerated dose (MTD) or recommended Phase II dose (RP2D) of EGF816 monotherapy in adult subjects with locally advanced (stage IIIB) or metastatic (stage IV) NSCLC harboring specific EGFR mutations. Patients may have or not have received prior lines of antineoplastic therapy. An adaptive Bayesian Logistic Regression Model (BLRM) employing the escalation with overdose control (EWOC) principle will be used during the dose escalation part for dose level selection and MTD recommendation. The primary objective of the Phase II part is to estimate antitumor activity of EGF816 as measured by overall response rate (ORR) determined by Blinded Independent Review Committee (BIRC) assessment in accordance to RECIST 1.1.
Key facts
- Study ID
- NCT02108964
- Run by
- Novartis Pharmaceuticals
- People needed
- 225
- Starts
- 2014-06-06
- Expected to finish
- 2023-08-15
- Last updated by the study team
- 2024-12-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Massachusetts General Hospital Mass General — Boston, Massachusetts, United States
- Memorial Sloan Kettering Oncology Department — New York, New York, United States
- Novartis Investigative Site — Toronto, Ontario, Canada
- Novartis Investigative Site — Berlin, Germany
- Novartis Investigative Site — Cologne, Germany
- Novartis Investigative Site — Nagoya, Aichi-ken, Japan
- Novartis Investigative Site — Fukuoka, Fukuoka, Japan
- Novartis Investigative Site — Zoetermeer, Netherlands
- Novartis Investigative Site — Singapore, Singapore
- Novartis Investigative Site — Seoul, South Korea
- Novartis Investigative Site — Seoul, South Korea
- Novartis Investigative Site — Barcelona, Catalonia, Spain
- Novartis Investigative Site — Madrid, Spain
- Novartis Investigative Site — Taipei, Taiwan
Full record on ClinicalTrials.gov
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