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NCT02108964 · ClinicalTrials.gov registry record · Phase 1
A Phase I/II, Multicenter, Open-label Study of EGFRmut-TKI EGF816, Administered Orally in Adult Patients With EGFRmut Solid Malignancies
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 225
- Enrollment target
NCT02108964 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 225 participants.
The verdict
NCT02108964, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 225 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG EGF816
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 225 participants |
| Start Date | 2014-06-06 |
| Est. Completion | 2023-08-15 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02108964
The ClinicalTrials.gov registry entry for NCT02108964 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 225 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which EGF816 is the first listed.
NCT02108964 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02108964 about?
NCT02108964 is a clinical study titled "A Phase I/II, Multicenter, Open-label Study of EGFRmut-TKI EGF816, Administered Orally in Adult Patients With EGFRmut Solid Malignancies". 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 ...
What is the current status of trial NCT02108964?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 225 participants. The study started on 2014-06-06. Estimated completion is 2023-08-15.
What interventions are being tested in trial NCT02108964?
The interventions under investigation include: EGF816 (DRUG).
Who is sponsoring clinical trial NCT02108964?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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