Study of IRX4204 With Erlotinib in Previously Treated Advanced NSCLC

Part of paid clinical trials in Lebanon, New Hampshire.

Sponsor
Io Therapeutics
Study ID
NCT02991651
Phase
PHASE1
Status
Terminated

Conditions

  • Lung Cancer, Nonsmall Cell

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IRX4204 — DRUG
    RXR agonist
  • erlotinib — DRUG
    inhibitor of phosphorylation of the tyrosine kinase associated with the epidermal growth factor receptor

Study Details

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.

Key Dates

First listed
Dec 13, 2016
Start date
Dec 7, 2016
Status verified
May 2025
Primary completion
May 9, 2025
Completion
May 9, 2025

Study Design

Enrollment
12 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Level 1
    IRX4204 5 mg/day PO + erlotinib 100 mg/day PO
  • Experimental: Dose Level 2
    IRX4204 5 mg/day PO + erlotinib 150 mg/day PO
  • Experimental: Dose Level 3
    IRX4204 10 mg/day PO + erlotinib 150 mg/day PO

Primary Outcome Measure

Safety of co-administration of IRX4204 + erlotinib to determine recommended phase 2 dose based on number of participants experiencing treatment-related adverse events as assessed as grade 4 by CTCAE v4.0 [ Time Frame: 30 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Geisel School of Medicine at DartmouthLebanonNew Hampshire03756-

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Geisel School of Medicine at Dartmouth· Lebanon, NH

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