Phase II Exploratory Trial to Evaluate the Efficacy and Safety of NOV120101 (Poziotinib) in Lung Adenocarcinoma Patients With Acquired Resistance to 1st Generation EGFR Tyrosine Kinase Inhibitors

Status: Completed
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2

The purpose of this open-label, single-arm, multi-center phase II trial is to evaluate the efficacy and safety of novel pan-HER inhibitor, NOV120101 (Poziotinib), as a 2nd line monotherapy agent in lung adenocarcinoma patients with acquired resistance to prior EGFR tyrosine kinase inhibitors (TKIs).

Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: No

• Male or female patients aged 20 years or older

• Pathologically confirmed stage IIIB (unresectable) or IV lung adenocarinoma

• Patients who have 1 or more than 1 measurable or evaluable but unmeasurable lesions according to RECIST ver1.1

• Patients who received prior 1st generation EGFR TKIs (gefitinib or erlotinib) monotherapy and meet the following criteria:

• Patients with EGFR mutation (e.g., G719X, exon 19 deletion, L858R, L861Q, etc) known to be associated with sensitivity to TKIs

• Patients who showed objective clinical benefit from treatment with an EGFR TKI as defined by either:

• Patients who showed complete (CR) or partial response (PR), or

• Patients who maintained stable disease (SD) status ≥ 6 months

• Patients who showed progressive disease (PD, RECIST ver1.1) while on continuous treatment with gefitinib or erlotinib within the last 30 days (However, patients whose progressive disease is limited in the brain cannot participate in this trial.)

• No intervening systemic chemotherapy between cessation of the EGFR TKI and participation of this study

• Patients who agree to the collection of tumor tissue specimen

• ECOG performance status ≤ 2

• Life expectancy of ≥ 12 weeks

• Adequate hematological, hepatic and renal functions:

• WBC ≥ 4,000/mm3, Platelet ≥ 100,000/mm3, Serum creatinine ≤ 1.5 X ULN, AST and ALT ≤ 2.5 X ULN, Total bilirubin ≤ 1.5 X ULN

• Patients who give written informed consent voluntarily

Other Locations
Republic of Korea
Chungbuk National University Hospital
Ulsan University Hospital
National Cancer Center
Gachon University Gil Medical Center
Asan Medical Center
Time Frame
Start Date: January 2013
Completion Date: September 2014
Target number of participants: 40
Experimental: NOV120101 (Poziotinib)
16 mg PO once daily until disease progression or unacceptable toxicity development
Eunkyung Cho, Ki Hyeong Lee, Sang-We Kim, Young Joo Min
Related Therapeutic Areas
Leads: National OncoVenture
Collaborators: Hanmi Pharmaceutical Company Limited

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