A Phase 2, Multicenter, Randomized Study of AP26113 (ALTA)
Non-small Cell Lung Cancer
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Phase 2 Study of AP26113 in Patients With ALK-positive, Non-small Cell Lung Cancer (NSCLC) Previously Treated With Crizotinib|
- Objective response rate (ORR) [ Time Frame: Confirmed ≥4 weeks after initial response. Until discontinuation or the end of the study. ]Defined as the composite of complete response (CR) and partial response (PR). To assess objective response rate in the intention to treat population.
- Overall survival (OS) [ Time Frame: Until the end of the study or death. ]Defined as the interval between enrollment and death due to any cause, censored at the last contact date. To assess OS in the intention to treat population.
- Progression-free survival (PFS) [ Time Frame: Until the end of the study or disease progression or death due to any cause. ]Defined as the duration of time from start of study drug administration to time of objective disease progression or death due to any cause, whichever may come first. To assess PFS in the intention to treat population.
- Health-related quality of life (HRQoL) [ Time Frame: Until 30 days after the last dose of study treatment. ]Defined as the perceived quality of the patient's life, which includes self-reported multidimensional measures of physical and mental health.
- Safety [ Time Frame: Until the end of the treatment. ]Measured by routine physical and laboratory evaluations, ECG, and adverse event (AE) monitoring. To evaluate the safety and tolerability of AP26113 in the intention to treat population.
- PK parameters of steady-state plasma concentration. [ Time Frame: At designated time points in dosing Cycles 2, 3, 4 and 5. ]PK samples will be taken to assess limited elements of PK in the intention to treat population.
|Study Start Date:||March 2014|
|Estimated Study Completion Date:||November 2017|
|Estimated Primary Completion Date:||November 2016 (Final data collection date for primary outcome measure)|
Experimental: Arm A:
AP26113 will be administered to eligible patients with locally advanced or metastatic ALK+ NSCLC at a dose of 90 mg QD, continuously.
90 mg tablet, taken orally once daily,continuously in a 28-day cycle
Experimental: Arm B:
AP26113 will be administered to eligible patients with locally advanced or metastatic ALK+ NSCLC at a dose of 90 mg QD for 7 days, then 180 mg QD, continuously.
90 mg tablet, taken orally once daily for a 7 days, then a 180 mg tablet taken orally once daily, continuously in a 28-day cycle
This is a randomized, phase 2, open-label, multicenter, international study to evaluate the efficacy and safety of two different dosing regimens of AP26113 in patients with ALK-positive, locally advanced or metastatic NSCLC who have previously been treated with crizotinib.
The primary objective of the study is to determine the efficacy of AP26113, as evidenced by confirmed objective response rate (ORR), as assessed by the investigator, per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Two dosing regimens will be tested. The secondary objectives of the study (for each dosing regimen) include confirmed ORR, as assessed by a central independent review committee (IRC), per RECIST v1.1; CNS response (ORR and progression free survival [PFS]), per RECIST v1.1, in patients with active brain metastases); time to/duration of response; time on treatment; disease control rate, per RECIST v.1.1; PFS; overall survival (OS); safety and tolerability; population pharmacokinetics (PK); and patient-reported symptoms of lung cancer and health-related quality of life (HRQoL). Exploratory objectives (for each dosing regimen) include correlation of AP26113 exposure with both efficacy and safety and correlation of tumor and plasma biomarkers with AP26113 efficacy and safety. It is estimated that accrual will be completed within 18 months; the total estimated duration of the study is 3 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02094573
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