Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02991651 · ClinicalTrials.gov registry record · Phase 1
Study of IRX4204 With Erlotinib in Previously Treated Advanced NSCLC
A Phase 1 study, sponsored by Io Therapeutics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT02991651 is a Phase 1 study that was terminated before completion, run by Io Therapeutics. The registered enrollment target is 12 participants.
The verdict
NCT02991651, a Phase 1 study, was terminated before completion, sponsored by Io Therapeutics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
Patient selection: a) Pathological confirmation of non-small cell lung cancer without activating EGFR mutations; b) Advanced stage disease (IV or IIIB with malignant effusion) with at least two prior chemotherapy regimens; c) No available curative therapy; d) Pregnant women are excluded; e) Informed consent. Pretreatment evaluation: a) Medical history and physical examination; b) Hepatic and renal function (bilirubin, aspartate aminotransaminase, creatinine); c) Preoperative staging evaluation including CT-chest or PET/CT scan; Treatment plan: Three dose levels of IRX4204 and erlotinib will be studied using intra-patient dose escalation for dose levels 1 and 2. These study agents will be administered orally until progression of disease, unacceptable toxicities, activation of a phase II study of the combination, or exhaustion of the IRX4204 drug supply. Evaluation on study: Adverse events will be graded on a scale of 0 to 5, using the Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0. Efficacy will be assessed using the RECIST v1.1 criteria based on CT-chest or PET/CT scan after 8 weeks of study treatment.
Interventions
- DRUG erlotinib
- DRUG IRX4204
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2016-12-07 |
| Est. Completion | 2025-05-09 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02991651
The ClinicalTrials.gov registry entry for NCT02991651 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Io Therapeutics, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which erlotinib is the first listed.
NCT02991651 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02991651 about?
NCT02991651 is a clinical study titled "Study of IRX4204 With Erlotinib in Previously Treated Advanced NSCLC". Patient selection: a) Pathological confirmation of non-small cell lung cancer without activating EGFR mutations; b) Advanced stage disease (IV or IIIB with malignant effusion) with at least two prior chemotherapy regimens; c) No available curative therapy; d) Pregnant women are excluded; e) Informed...
What is the current status of trial NCT02991651?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2016-12-07. Estimated completion is 2025-05-09.
What interventions are being tested in trial NCT02991651?
The interventions under investigation include: erlotinib (DRUG), IRX4204 (DRUG).
Who is sponsoring clinical trial NCT02991651?
This trial is sponsored by Io Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.