At a glance
ClinicalIndex Comparison Record- ✓Unresectable stage IIIB or IV NSCLC
- ✓No more than one prior chemotherapy regimen
- ✓Measurable or evaluable disease on imaging
- ✓ECOG performance status 0 or 1
- ✕Symptomatic or untreated CNS metastases requiring current treatment
- ✕History of arterial thrombosis within 1 year prior to enrollment
- ✕History of myocardial infarction within 1 year before enrollment
- ✕Uncontrolled hypertension (diastolic >85 mmHg; systolic >145 mmHg)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label, Dose-finding Study to Evaluate the Safety and Pharmacokinetics (PK) of AMG 706 With Carboplatin/Paclitaxel, AMG 706 With Panitumumab and AMG 706 With Panitumumab and Carboplatin/Paclitaxel in the Treatment of Subjects With Advanced Non-Small Cell Lung Cancer (NSCLC)
In Brief
A Phase 2 clinical trial evaluating Panitumumab, Motesanib diphosphate, and 2 other interventions for Lung Cancer and Non-Small Cell Lung Cancer. Completed, enrolled 51 participants.
Detailed Summary
The purpose of this trial is: - To characterize the safety profile of motesanib when used in combination with carboplatin/paclitaxel (CP), with panitumumab or with CP and panitumumab in patients with advanced non-small cell lung cancer (NSCLC). - To establish the pharmacokinetic (PK) profile of motesanib when it is used in combination with CP, with panitumumab, or with CP and panitumumab. - To compare the paclitaxel and motesanib PK profiles when the medications are administered 30 minutes (min) or approximately 48 hours (hrs) apart. - To characterize the panitumumab and paclitaxel exposure in the combination regimens of motesanib with CP, motesanib with panitumumab, or motesanib with CP and panitumumab. - To describe the objective response rate (ORR) in each dose cohort. - To measure the immunogenicity of panitumumab in patients administered motesanib with panitumumab and motesanib with CP and panitumumab.
Study Details
Timeline
Interventions
9.0 mg/kg on Day 1 of each 21-day cycle administered by intravenous infusion over approximately 60 minutes.
Dose-finding with an initial dose of 50 mg once daily and up to 125 mg once daily. 75 mg twice daily was also to be tested.
Paclitaxel 200 mg/m\^2 administered by IV infusion over 3 hours.
Carboplatin was administered IV over approximately 30 minutes. Carboplatin was dosed using the glomerular filtration rate (GFR) and Calvert formula to AUC/time curve of 6 mg/mL×min.