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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: Completed Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT02108964 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 225 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (275% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number of participants with DLTs during the first 28 days of therapy. A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle of treatment with EGF816 and meets any of the criteria described in the protocol. A participant with multiple occurrences of DLTs under one treatment is counted only once.
Interventions
- DRUG EGF816
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 225 participants |
| Start Date | 2014-06-06 |
| Est. Completion | 2023-08-15 |
| Phase | Phase 1 |
What the finished NCT02108964 record still lists
NCT02108964 is an interventional study that assigns participants to a tested intervention. The registered 225 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (275% higher).
The record links to 0 conditions, and to 1 intervention - of which EGF816 is the first listed.
NCT02108964 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02108964's enrollment target sits among peer trials
225 223rd of 2000 higher than 1,774 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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