AMG 102 and Erlotinib for Advanced Non-Small Cell Lung Cancer
This is a phase I/II study of erlotinib and AMG 102 in previously treated subjects with advanced NSCLC. Subjects will be enrolled with recurrent or progressive advanced stage NSCLC that has been treated with at least one and a maximum of two prior chemotherapy regimens. The Phase I part of the study will enroll 8-16 subjects with the Phase II part enrolling 21-45 subjects.
The Phase I part of the study is designed to determine how safest the combination of AMG 102 and erlotinib is and the recommended dose for the Phase II part. The Phase II part is to determine whether the combination of AMG102 and erlotinib works enough to warrant further interest in this combination.
|Carcinoma, Non-Small-Cell Lung||Drug: AMG 102 and erlotinib||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase I/II Trial of AMG 102 and Erlotinib in Previously Treated Patients With Advanced Non-Small Cell Lung Cancer|
- Percentage of Participants That Experienced a Dose Limiting Toxicity [ Time Frame: During first cycle of treatment (3 weeks) ]Determination of the safety and recommended phase II dose of AMG 102 when combined with erlotinib for the treatment of patients with advanced, previously-treated NSCLC.
- Disease Control Rate (DCR) [ Time Frame: Six weeks from initiation of treatment with AMG 102 + Erlotinib ]Using RECIST v1.1 criteria, DCR was determined by following equation: the number of complete response (CR) participants + the number of partial response (PR) participants + the number of stable disease (SD) participants / the number of complete response (CR) participants + the number of partial response (PR) participants + the number of stable disease (SD) participants + the number of progressive disease (PD) participants.
- Objective Response Rate (ORR/Clinical Response) [ Time Frame: Up to 6 months ]Using RECIST v1.1 criteria, ORR was determined by following equation: the number of partial response (PR) participants / the number of partial response (PR) participants + the number of stable disease (SD) participants + the number of progressive disease (PD) participants.
- Progression-free Survival (PFS) [ Time Frame: Up to 24 months (after the first patient is accrued) ]Progression-free survival is defined as the time from the start of treatment until first evidence of disease progression, death, or date of last contact. The (median) length of time that subjects with previously-treated advanced NSCLC, who were treated with the combination of AMG 102 and erlotinib, are both alive and free of disease progression as estimated by the Kaplan-Meier method. For participants not known to have died as of the data cut-off date and who did not have PD, the PFS date was censored at the last contact date (contacts considered in the determination of last progression free disease assessment).
- Overall Survival (OS) [ Time Frame: Up to 24 months (after the first evaluable patient is accrued) ]Overall Survival was computed for all participants and is defined as the time between start of treatment and death. The (median) length of time in months that subjects with previously-treated advanced NSCLC, treated with the combination of AMG 102 and erlotinib, remain alive estimated by the Kaplan-Meier method.
|Study Start Date:||August 2011|
|Study Completion Date:||November 2014|
|Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
Experimental: AMG 102 and erlotinib
Combination of AMG 102 and erlotinib
Drug: AMG 102 and erlotinib
Dose Level -2 Dose level -1 Dose Level 0 AMG 102 5 mg/kg 7.5 mg/kg 15 mg/kg Erlotinib 150 mg 150 mg 150 mg
The first cohort of patients in the phase I portion will start at dose level 0 of AMG102.
Other Name: Rilotumumab
Please refer to this study by its ClinicalTrials.gov identifier: NCT01233687
|United States, Pennsylvania|
|University of Pittsburgh Cancer Institute|
|Pittsburgh, Pennsylvania, United States, 15232|
|Principal Investigator:||Ahmad Tarhini, MD||University of Pittsburgh|