Entry Detail
| General information | |
| Database: | DB00741 |
| Objective: | Thisphase II study estimated the difference in objective response rate (ORR) among patients with advanced nonsquamous non small cell lung cancer (non small cell lung cancer) receiving paclitaxelcarboplatin (CP) plus motesanib or bevacizumab. |
| Authors: | Blumenschein GR Jr, et al |
| Title: | a phase II, multicenter, openlabel randomized study of motesanib or bevacizumab in combination with paclitaxel and carboplatin for advanced nonsquamous non small cell lung cancer. |
| Journal: | Ann Oncol. |
| Year: | 2011 |
| PMID: | 21321086 |
| Trial Design | |
| Clinical Trial Id: | NCT00369070 |
| Agent: | motesanib |
| Target: | Mast/stem cell growth factor receptor Plateletderived growth factor receptor Vascular endothelial growth factor receptor 2 |
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | advanced nonsquamous non small cell lung cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | paclitaxel+carboplatin + motesanib |
| Study Type: | a phase II, multicenter, openlabel randomized study |
| Key Patients Feature: | Eligible patients (more than and equal to 18 years) had histologically or cytologically confirmed advanced nonsquamous non small cell lung cancer [unresectable stage IIIB with malignant effusion or stage IV/recurrent; no specific TNM (tumor-node-metastasis) staging was required), Eastern Cooperative Oncology Group (ECOG) performance status of one or less, measurable disease according to RECIST, and life expectancy more than and equal to 3 months. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | paclitaxelcarboplatin plus motesanib Versus motesanib |
| Treatment Info: | Chemotherapynaive patients (N = 186) were randomized 1:1:1 to receive CP plus motesanib 125 mg once daily (qd) (arm A), motesanib 75 mg twice daily (b.i.d.) 5 days on/2 days off (arm B), or bevacizumab 15 mg/kg every 3 weeks (q3w) (arm C). |
| Primary End Point: | ORR (per RECIST). |
| Secondary End Point: | progression free survival (PFS), overall survival (OS), motesanib pharmacokinetics, and adverse events (AEs). |
| Patients Number: | 186 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | arm A, 30% (95% confidence interval 18% to 43%); arm B, 23% (13% to 36%); and arm C, 37% (25% to 50%). |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | arm A was 7.7 months, arm B 5.8 months, and arm C 8.3 months |
| Median OS A vs. C: | arm A was 14.0 months, arm B 12.8 months, and arm C 14.0 months |
| Adverse Event(agent arm): | Treatmentemergent AEs occurred in 95%, 97%, and 93% of patients in arms A, B, and C, respectively (Table 3). Overall, the patient incidence rate of most any grade, grade more than and equal to 3 AEs, and AEs leading to treatment discontinuation was higher in the motesanib treatment arms. Exceptions were peripheral neuropathy and myalgia (arm A, n = 4; arm B, n = 4; arm C, n = 10), which occurred more frequently in the bevacizumab arm (arm C). Of note, for five patients in arm A and one patient each in arms B and C, non small cell lung cancer progression was recorded as a grade 5 AE. |
| Conclusions: | The efficacy of 125 mg qd motesanib or bevacizumab plus CP was estimated to be comparable. Toxicity was higher but manageable in both motesanib arms. Efficacy and tolerability of motesanib 125 mg qd plus CP in advanced nonsquamous non small cell lung cancer are being further investigated in aphase III study. |