Study of IRX4204 With Erlotinib in Previously Treated Advanced NSCLC

  • STATUS
    Recruiting
  • days left to enroll
    89
  • participants needed
    12
  • sponsor
    Io Therapeutics
Updated on 24 January 2021
ct scan
tyrosine
growth factor
pleural effusion
metastasis
neutrophil count
erlotinib
epidermal growth factor receptor
EGFR
brain metastases
cancer chemotherapy
epidermal growth factor
adjuvant chemotherapy
stage iv non-small cell lung cancer
kidney function test
recurrent non-small cell lung cancer
lung carcinoma

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.

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.

Details
Condition Non-Small Cell Lung Cancer
Treatment Erlotinib, IRX4204
Clinical Study IdentifierNCT02991651
SponsorIo Therapeutics
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients must have histologically or cytologically confirmed stage IV non-small cell lung cancer, or recurrent non-small cell lung cancer which is not amenable to curative intent therapy
Documented disease progression on at least two prior lines of chemotherapy for advanced NSCLC. Progression within 6 months of adjuvant chemotherapy or definitive chemoradiation will count as one line of therapy
Age 18 years
ECOG performance status 2
Ability to take pills by mouth
Patients must have normal organ and marrow function as defined below
Leukocytes 3,000/mcL
Absolute neutrophil count 1,500/mcL
Platelets 100,000/mcL
Hemoglobin 8.5 g/dL
Total bilirubin 1.5 x institutional upper limit of normal (ULN)
AST(SGOT)/ALT(SGPT) 2.5 ULN or 5 x ULN if metastases to the liver
Creatinine clearance 40 mL/min
Patients with asymptomatic brain metastases are allowed, as long as they are stable and do not require treatment with anticonvulsants or escalating doses of steroids. Maximum daily dose of steroids should be prednisone 20 mg or equivalent. Radiation therapy for brain metastases must be completed at least 14 days prior to treatment on protocol
Women of child-bearing potential and men must agree to use highly effective contraception (if using hormonal birth control must add a second barrier method; abstinence) prior to study entry, for the duration of study participation as well as for at least 1 month after the last dose of IRX4204. Men treated or enrolled on this protocol must also agree to use highly effective contraception prior to the study, for the duration of study participation and 3 months after completion of IRX4204 administration
Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study
Activating EGFR mutations detected in the tumor
Prior treatment with an EGFR tyrosine kinase inhibitor
Prior treatment with IRX4204 or another retinoid or rexinoid administered for the purpose of cancer treatment. Prior topical retinoid use is allowed
History of allergic reactions attributed to IRX4204 or erlotinib or to compounds of similar chemical or biologic composition
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Pregnant and nursing women
Patients with a history of another active malignancy within the past two years, with the exception of non-melanoma cutaneous malignancy, cervical carcinoma in situ, or ductal carcinoma in situ which has been successfully treated with curative intent therapy
Any gastrointestinal disorder expected to limit absorption of IRX4204 or erlotinib
Patients with a history of active thyroid disease. However, patients with a history of hypothyroidism maintained in euthyroid state by supplementation with thyroid hormone, or a thyroid hormone containing preparation may be enrolled
Patients taking coumarin-derived anticoagulants
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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