NCT02991651

Study of IRX4204 With Erlotinib in Previously Treated Advanced NSCLC

A Phase I Study of IRX4204 in Combination With Erlotinib in Patients With Previously Treated Advanced Non-Small Cell Lung Cancer

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Io Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Numerous studies in pre-clinical models and in human clinical trials have clearly established the potential for the use of rexinoids in the treatment and prevention of cancer. IRX4204, a second generation rexinoid, is a highly potent and specific activator of RXRs. Because IRX4204 is significantly more potent and more selective for the RXRs relative to the RARs than a first generation approved RXR agonist drug, bexarotene, it potentially will be associated with fewer adverse events and greater activity in clinical use. Preclinical studies of the combination of IRX4204 plus erlotinib, and previous clinical studies of the combination of the bexarotene plus erlotinib indicated at least additive beneficial effects for treatment of NSCLC. This study seeks to investigate the safety and activity of IRX4204 in combination with erlotinib in patients with previously treated advanced NSCLC.

Conditions

• Lung Cancer, Nonsmall Cell

Interventions

Type	Name	Description
DRUG	IRX4204	RXR agonist
DRUG	erlotinib	inhibitor of phosphorylation of the tyrosine kinase associated with the epidermal growth factor receptor

Timeline

• Start date: 2016-12-07
• Primary completion: 2025-05-09
• Completion: 2025-05-09
• First posted: 2016-12-13
• Last updated: 2025-05-14

Locations

1 site across 1 country: United States