This is an open-label, multicenter, multiple-dose, Phase I-II study of CHR-2797 co-administered with erlotinib in patients with histologically or pathologically confirmed Stage IIIB (with pleural effusion), Stage IV, or recurrent metastatic NSCLC. Throughout this protocol, "study medication" includes both CHR-2797 and erlotinib. This study will involve 2 distinct study phases. Study Phase A will assess safety and determine the MTD of the combination of CHR-2797 and erlotinib. In addition, PK profiles for the combination of CHR-2797 and erlotinib will be evaluated. In Study Phase B, the dose chosen based on the maximum tolerated dose established in Study Phase A will be administered in a single-arm treatment design in order to evaluate the efficacy of co-administration of CHR-2797 and erlotinib.
Study Phase A: Maximum tolerated dose will be determined during Cycle 1. Tumor assessments will be made after Cycle 2 (56 days), although it is not mandatory for Phase A patients to have measurable disease. Patients who have satisfactory outcomes after Cycle 2 may continue treatment for up to a year with erlotinib 150 mg/day, and the dose of CHR-2797 they received in Study Phase A. Study Phase B: Patients will be treated with the dose of CHR-2797 selected in Study Phase A and 150mg/day erlotinib. Patients will receive 2 cycles of treatment (56 days) before efficacy assessment. Patients who have complete response, partial response, or stable disease are eligible to continue the study for up to a year until disease progression or unacceptable toxicity. If a patient has complete response, partial response, or stable disease at the end of the 1-year study period and the Investigator believes that continuation treatment would be beneficial, the patient may continue to be treated at the dose of CHR-2797 under a separate protocol.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
2
Once daily, oral ingestion of CHR-2797 capsules(PhaseI: 120mg, 160mg or 200mg depending on cohort or Phase II: recommended dose) capsules until progressive disease or withdrawal from the study
Once daily, oral ingestion of erlotinib tablets 150mg tablets until progressive disease or withdrawal from the study. Per protocol, the Investigator may reduce the dose of erlotinib or cease treatment with erlotinib(per label) with Sponsor approval.
Tower Cancer Research Foundation
Beverly Hills, California, United States
Medical Oncology Care Associates
Orange, California, United States
Oncology Associates of West Kentucky
Paducah, Kentucky, United States
Richmond University Medical Center
Staten Island, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Clinworks Research Center
Charlotte, North Carolina, United States
Carolina BioOncology Institute
Huntersville, North Carolina, United States
Study Phase A- To determine the safety, tolerability, and maximum tolerated dose (MTD) of CHR-2797 when co-administered with erlotinib
Time frame: end of study
Study Phase B- To determine the objective tumor response rate to CHR-2797 and erlotinib when co-administered to patients with histologically and/or pathologically confirmed Stage IIIB, Stage IV, or recurrent metastatic non-small cell lung cancer (NSCLC)
Time frame: End of study
Study Phase A- To determine the pharmacokinetic (PK) profiles of CHR-2797 and erlotinib when co-administered
Time frame: End of study
Study Phase B- To further evaluate the efficacy of the combination of CHR-2797 and erlotinib in patients with locally advanced or metastatic non small cell lung cancer (NSCLC)
Time frame: End of study
Study Phase B- To determine the safety and tolerability of CHR-2797 and erlotinib when co administered. To determine the trough levels of CHR-2797 and erlotinib after co-administration for 28 days
Time frame: End of study
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