Phase 2
Completed N=51
Study to Evaluate Motesanib With or Without Carboplatin/Paclitaxel or Panitumumab in the Treatment of Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
Source: ClinicalTrials.gov NCT00094835 ↗Enrolled (actual)
51
Serious AEs
37.8%
Results posted
Mar 2014
Primary outcomePrimary: Time to Maximum Plasma Concentration of Motesanib (Tmax) for Cycle 1 — 0.75; 1.0; 0.75; 1.5 hours
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Maximum Plasma Concentration of Motesanib (Tmax) for Cycle 1 |
0.75; 1.0; 0.75; 1.5; 1.0; 0.58 | — |
| PRIMARY Maximum Observed Plasma Concentration of Motesanib (Cmax) in Cycle 1 |
158; 525; 448; 328; 444; 198 | — |
| PRIMARY Estimated Terminal-phase Half-life (t1/2,z) of Motesanib in Cycle 1 |
7.34; 5.33; 5.77; 6.47; 7.57; 8.28 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve for Motesanib in Cycle 1 |
0.971; 3.21; 2.91; 1.74; 3.23; 2.04 | — |
| PRIMARY Trough Plasma Concentration at 24 Hours Post-dose (C24) for Motesanib in Cycle 1 |
9.12; 26.5; 56.7; 14.0; 32.5; 56.8 | — |
| PRIMARY Time to Maximum Plasma Concentration of Motesanib (Tmax) in Cycle 2 |
1.5; 1.0; 0.63; 1.0; 0.75; 1.0 | — |
| PRIMARY Maximum Observed Plasma Concentration of Motesanib (Cmax) in Cycle 2 |
148; 748; 390; 265; 672; 242 | — |
| PRIMARY Estimated Terminal-phase Half-life (t1/2,z) of Motesanib in Cycle 2 |
6.41; 6.36; 7.08; 4.90 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours Post-dose for Motesanib in Cycle 2 |
4.50; 3.11; 1.26; 3.92; 3.16 | — |
| PRIMARY Trough Plasma Concentration at 24 Hours Post-dose (C24) for Motesanib in Cycle 2 |
43.4; 45.4; 10.4; 61.1; 45.1 | — |
| SECONDARY Percentage of Participants With an Overall Objective Response |
33; 18; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of unresectable stage IIIB or IV non-small cell lung cancer (NSCLC)
- No more than one prior chemotherapy
- Adequate hematologic, renal and hepatic function
- Measurable disease or evaluable disease on CAT scan or MRI
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Able to fast for 10 hrs twice during the study - Able to tolerate oral medications
- Life expectancy of at least 3 months
Exclusion Criteria
- Symptomatic or untreated central nervous system metastases requiring current treatment
- History of arterial thrombosis within 1 year prior to enrollment
- Anticoagulant therapy, except for warfarin of less than 2mg per day
- Symptomatic peripheral neuropathy
- History of pulmonary hemorrhage or hemoptysis
- Myocardial infarction within 1 year before enrollment
- Uncontrolled hypertension [diastolic greater than 85 mmHg; systolic greater than 145 mmHg]
- History of other cancer, unless treated with no known active disease for longer than 3 years
- Previous treatment with AMG 706 or panitumumab, previous treatment with inhibitors of VEGF or EGF
- No antibody treatment for 6 weeks prior to enrollment
- Known HIV positive, hepatitis C positive or hepatitis B surface antigen positive
Data sourced from ClinicalTrials.gov (NCT00094835). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.