Clinical trial · Interventional

Study to Evaluate Motesanib With or Without Carboplatin/Paclitaxel or Panitumumab in the Treatment of Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

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)

NCT00094835CI-TRIAL-00021476completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Lung Cancer	Malignant Lung Neoplasm	CURATED_EXACT	0.92
Non-Small Cell Lung Cancer	Lung Non-Small Cell Carcinoma	ALIAS	0.90

Interventions

Interventions (4)

Intervention	Type	Mapped drug	Match
Carboplatin	Drug	Carboplatin	ALIAS
Motesanib diphosphate	Drug	Motesanib	ALIAS
Paclitaxel	Drug	Paclitaxel	ALIAS
Panitumumab	Biological	Panitumumab	ALIAS

Design

Arms and outcomes

Arms (3)

type
EXPERIMENTAL
label
Paclitaxel + Carboplatin + Motesanib
description
Chemotherapy naïve participants received paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. The initial dose of motesanib was 50 mg once daily administered in the initial cohort and up to 125 mg once daily was used in subsequent cohorts. A cycle was defined as the 3 weeks plus the time to recover from toxicity, if encountered.
interventionNames
1. Drug: Motesanib diphosphate
2. Drug: Paclitaxel
3. Drug: Carboplatin
type
EXPERIMENTAL
label
Panitumumab + Motesanib
description
Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab administered by IV at 9.0 mg/kg on Day 1 of each 21-day cycle, and motesanib, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. The initial dose of motesanib was 50 mg once daily administered in the initial cohort, up to 125 mg once daily was used in subsequent cohorts.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (1)

BACKGROUNDBlumenschein GR Jr, Reckamp K, Stephenson GJ, O'Rourke T, Gladish G, McGreivy J, Sun YN, Ye Y, Parson M, Sandler A. Phase 1b study of motesanib, an oral angiogenesis inhibitor, in combination with carboplatin/paclitaxel and/or panitumumab for the treatment of advanced non-small cell lung cancer. Clin Cancer Res. 2010 Jan 1;16(1):279-90. doi: 10.1158/1078-0432.CCR-09-1675. Epub 2009 Dec 22. PMID 20028752