Lung CancerPhase 1/2NCT00094835

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

A Phase 1/2 study testing Panitumumab, Motesanib diphosphate and Paclitaxel in people with Lung Cancer and Non-Small Cell Lung Cancer, run by Amgen.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Lung Cancer, Non-Small Cell Lung Cancer
What is being tested?: Panitumumab, Motesanib diphosphate and Paclitaxel
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 51 participants
Where: No sites listed yet
Study dates: Jan 2005to Mar 2007
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

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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

About this study

Official title: 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)

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.

Read the detailed description

This was a multicenter, open-label, dose-finding clinical trial examining the safety and PK of once or twice daily motesanib administered with CP or with CP and panitumumab in chemotherapy naïve patients, and with panitumumab in patients with no more than one prior chemotherapy regimen for NSCLC.

Participants were enrolled into the Panitumumab + Paclitaxel + Carboplatin + Motesanib once a safe and tolerable dose of AMG 706 was established in the other treatment arms.

Conditions: Lung Cancer, Non-Small Cell Lung Cancer
Being tested: Panitumumab, Motesanib diphosphate, Paclitaxel, Carboplatin
Keywords: Lung cancer, Non-small cell lung cancer, NSCLC, Clinical Trial, Panitumumab, AMG 706, Anti-angiogenesis, Immunex, Abgenix, Amgen, Stage IIIB, Stage IV, Unresectable
Medical subject headings: Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PanitumumabBiological
Also called Vectibix, ABX-EGF
9.0 mg/kg on Day 1 of each 21-day cycle administered by intravenous infusion over approximately 60 minutes.
Motesanib diphosphateDrug
Also called AMG 706
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.
PaclitaxelDrug
Paclitaxel 200 mg/m^2 administered by IV infusion over 3 hours.
CarboplatinDrug
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.

Study groups in NCT00094835
Study group	Role	What they receive
Paclitaxel + Carboplatin + Motesanib	Experimental	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. Receives: Drug: Motesanib diphosphate; Drug: Paclitaxel; Drug: Carboplatin
Panitumumab + Motesanib	Experimental	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. Receives: Biological: Panitumumab; Drug: Motesanib diphosphate
Panitumumab + Paclitaxel + Carboplatin + Motesanib	Experimental	Chemotherapy naïve participants received panitumumab administered by IV at 9.0 mg/kg on Day 1 of each 21-day cycle, paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by 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. Participants were enrolled in this arm once a safe and tolerable dose of motesanib was established. Receives: Biological: Panitumumab; Drug: Motesanib diphosphate; Drug: Paclitaxel; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to Maximum Plasma Concentration of Motesanib (Tmax) for Cycle 1
The time after dosing that the maximal plasma concentration of motesanib was observed in Cycle 1. For the 75 mg BID cohorts, Tmax is reported for the first daily dose.
Measured: Cycle 1, Day 3 at predose, 15 and 30 minutes, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose.
Maximum Observed Plasma Concentration of Motesanib (Cmax) in Cycle 1
The maximal observed plasma concentration of motesanib after a single dose dose in Cycle 1. For the 75 mg BID cohorts, Cmax is reported for the first daily dose.
Measured: Cycle 1, Day 3 at predose, 15 and 30 min, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose.
Estimated Terminal-phase Half-life (t1/2,z) of Motesanib in Cycle 1
The terminal-phase elimination half-life (t1/2,z) of motesanib was calculated as ln(2)/λz. The terminal elimination rate constant (λz) was determined by linear regression of the natural logarithms of at least the last 3 measurable concentrations during the terminal phase. For the 75 mg BID cohorts, t1/2,z is reported for the first daily dose.
Measured: Cycle 1, Day 3 at predose, 15 and 30 min, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours postdose.
Area Under the Plasma Concentration-time Curve for Motesanib in Cycle 1
Area under the plasma concentration-time curve for motesanib in Cycle 1 calculated using the using the linear/log trapezoidal method. AUC from time zero to infinity (AUC0-inf) is reported for the 50 and 125 mg QD cohorts and AUC from time 0 to 24 hours post-dose (AUC0-24) is reported for the 75 mg BID cohort, where AUC0-24 is the sum of AUC0-12 for the first and second daily dose.
Measured: Cycle 1, Day 3 at predose, 15 and 30 minutes, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose.
Trough Plasma Concentration at 24 Hours Post-dose (C24) for Motesanib in Cycle 1
The trough plasma concentration for motesanib at 24 hours postdose in Cycle 1. For the 75 BID cohort, C24 is the observed concentration at 24 hours (ie, after the second daily dose).
Measured: Cycle 1, Day 3, 24 hours post-dose
Time to Maximum Plasma Concentration of Motesanib (Tmax) in Cycle 2
The time after dosing that the maximal plasma concentration of motesanib was observed in Cycle 2. For the 75 mg BID cohorts, Tmax is reported for the first daily dose.
Measured: Cycle 2, Day 1 at predose, 15 and 30 min, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose.
Maximum Observed Plasma Concentration of Motesanib (Cmax) in Cycle 2
The maximal observed plasma concentration of motesanib in Cycle 2, after multiple doses. For the 75 mg BID cohorts, Cmax is reported for the first daily dose.
Measured: Cycle 2, Day 1 at predose, 15 and 30 min, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose.
Estimated Terminal-phase Half-life (t1/2,z) of Motesanib in Cycle 2
The terminal-phase elimination half-life (t1/2,z) of motesanib was calculated as ln(2)/λz. The terminal elimination rate constant (λz) was determined by linear regression of the natural logarithms of at least the last 3 measurable concentrations during the terminal phase. For the 75 mg BID cohorts, t1/2,z is reported for the first daily dose.
Measured: Cycle 2, Day 1 at predose, 15 and 30 min, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose.
Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours Post-dose for Motesanib in Cycle 2
Area under the plasma concentration-time curve from time 0 to 24 hours post-dose (AUC0-24) for motesanib in Cycle 2 calculated using the using the linear/log trapezoidal method. For the 75 mg BID cohort AUC0-24 is the sum of AUC0-12 for the first and second daily dose.
Measured: Cycle 2, Day 1 at predose, 15 and 30 minutes, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose.
Trough Plasma Concentration at 24 Hours Post-dose (C24) for Motesanib in Cycle 2
The trough plasma concentration for motesanib at 24 hours postdose in Cycle 2. For the 75 BID cohort, C24 is the observed concentration at 24 hours (ie, after the second daily dose).
Measured: Cycle 2, Day 1, 24 hours post-dose

Secondary outcomes (1)

Percentage of Participants With an Overall Objective Response
Confirmed objective tumor response defined as a complete response (CR) or partial response (PR) using modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Tumor response was evaluated by computed tomography (CT) scan or magnetic resonance imaging (MRI). Responding disease (CR or PR) was confirmed no less than 4 weeks after the criteria for response were first met. A complete response defined as the disappearance of all target lesions and all non-target lesions, no new lesions and normalization of tumor marker level. Partial response defined as either the disappearance of all target lesions and the persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diamer (LD) of target lesions, taking as reference the baseline sum LD and no new lesions and/or unequivocal progression of existing non-target lesions.
Measured: After 9 weeks of treatment (at the end of Cycle 3)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2005Mar 2007

First posted27 Oct 2004 (estimated)
Study startJan 2005
Primary completionMar 2007
Study completionMar 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Lung CancerStudies of the same condition, open and under way.
More trials run by AmgenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00094835
Sponsor's protocol ID: 20040153
Status last verified: Feb 2016
First submitted: 27 Oct 2004
Last updated: 24 Mar 2016
Results posted: Yes, on ClinicalTrials.gov

Publications

Blumenschein 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.
PubMed 20028752

Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT00094835
Acronym / sponsor ID: 20040153
Conditions: Lung Cancer, Non-Small Cell Lung Cancer
Keywords: Lung cancer, Non-small cell lung cancer, NSCLC, Clinical Trial, Panitumumab, AMG 706, Anti-angiogenesis, Immunex, Abgenix, Amgen, Stage IIIB, Stage IV, Unresectable
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: Jan 2005
Primary completion: Mar 2007 (actual)
Study completion: Mar 2007 (actual)
First posted: 27 Oct 2004 (estimated)
Results: Posted 24 Mar 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Participants were enrolled into the Panitumumab + Paclitaxel + Carboplatin + Motesanib once a safe and tolerable dose of AMG 706 was established in the other treatment arms.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Paclitaxel + Carboplatin + Motesanib	Experimental	Drug: Motesanib diphosphate, Drug: Paclitaxel, Drug: CarboplatinChemotherapy 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.
Panitumumab + Motesanib	Experimental	Biological: Panitumumab, Drug: Motesanib diphosphateParticipants 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.
Panitumumab + Paclitaxel + Carboplatin + Motesanib	Experimental	Biological: Panitumumab, Drug: Motesanib diphosphate, Drug: Paclitaxel, Drug: CarboplatinChemotherapy naïve participants received panitumumab administered by IV at 9.0 mg/kg on Day 1 of each 21-day cycle, paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by 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. Participants were enrolled in this arm once a safe and tolerable dose of motesanib was established.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PanitumumabAlso: Vectibix, ABX-EGF9.0 mg/kg on Day 1 of each 21-day cycle administered by intravenous infusion over approximately 60 minutes.	Biological	Panitumumab + Motesanib, Panitumumab + Paclitaxel + Carboplatin + Motesanib
Motesanib diphosphateAlso: AMG 706Dose-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.	Drug	Paclitaxel + Carboplatin + Motesanib, Panitumumab + Motesanib, Panitumumab + Paclitaxel + Carboplatin + Motesanib
PaclitaxelPaclitaxel 200 mg/m^2 administered by IV infusion over 3 hours.	Drug	Paclitaxel + Carboplatin + Motesanib, Panitumumab + Paclitaxel + Carboplatin + Motesanib
CarboplatinCarboplatin 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.	Drug	Paclitaxel + Carboplatin + Motesanib, Panitumumab + Paclitaxel + Carboplatin + Motesanib

Primary outcome

Time to Maximum Plasma Concentration of Motesanib (Tmax) for Cycle 1
Time frame: Cycle 1, Day 3 at predose, 15 and 30 minutes, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose.
The time after dosing that the maximal plasma concentration of motesanib was observed in Cycle 1. For the 75 mg BID cohorts, Tmax is reported for the first daily dose.
Maximum Observed Plasma Concentration of Motesanib (Cmax) in Cycle 1
Time frame: Cycle 1, Day 3 at predose, 15 and 30 min, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose.
The maximal observed plasma concentration of motesanib after a single dose dose in Cycle 1. For the 75 mg BID cohorts, Cmax is reported for the first daily dose.
Estimated Terminal-phase Half-life (t1/2,z) of Motesanib in Cycle 1
Time frame: Cycle 1, Day 3 at predose, 15 and 30 min, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours postdose.
The terminal-phase elimination half-life (t1/2,z) of motesanib was calculated as ln(2)/λz. The terminal elimination rate constant (λz) was determined by linear regression of the natural logarithms of at least the last 3 measurable concentrations during the terminal phase. For the 75 mg BID cohorts, t1/2,z is reported for the first daily dose.
Area Under the Plasma Concentration-time Curve for Motesanib in Cycle 1
Time frame: Cycle 1, Day 3 at predose, 15 and 30 minutes, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose.
Area under the plasma concentration-time curve for motesanib in Cycle 1 calculated using the using the linear/log trapezoidal method. AUC from time zero to infinity (AUC0-inf) is reported for the 50 and 125 mg QD cohorts and AUC from time 0 to 24 hours post-dose (AUC0-24) is reported for the 75 mg BID cohort, where AUC0-24 is the sum of AUC0-12 for the first and second daily dose.
Trough Plasma Concentration at 24 Hours Post-dose (C24) for Motesanib in Cycle 1
Time frame: Cycle 1, Day 3, 24 hours post-dose
The trough plasma concentration for motesanib at 24 hours postdose in Cycle 1. For the 75 BID cohort, C24 is the observed concentration at 24 hours (ie, after the second daily dose).
Time to Maximum Plasma Concentration of Motesanib (Tmax) in Cycle 2
Time frame: Cycle 2, Day 1 at predose, 15 and 30 min, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose.
The time after dosing that the maximal plasma concentration of motesanib was observed in Cycle 2. For the 75 mg BID cohorts, Tmax is reported for the first daily dose.
Maximum Observed Plasma Concentration of Motesanib (Cmax) in Cycle 2
Time frame: Cycle 2, Day 1 at predose, 15 and 30 min, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose.
The maximal observed plasma concentration of motesanib in Cycle 2, after multiple doses. For the 75 mg BID cohorts, Cmax is reported for the first daily dose.
Estimated Terminal-phase Half-life (t1/2,z) of Motesanib in Cycle 2
Time frame: Cycle 2, Day 1 at predose, 15 and 30 min, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose.
The terminal-phase elimination half-life (t1/2,z) of motesanib was calculated as ln(2)/λz. The terminal elimination rate constant (λz) was determined by linear regression of the natural logarithms of at least the last 3 measurable concentrations during the terminal phase. For the 75 mg BID cohorts, t1/2,z is reported for the first daily dose.
Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours Post-dose for Motesanib in Cycle 2
Time frame: Cycle 2, Day 1 at predose, 15 and 30 minutes, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose.
Area under the plasma concentration-time curve from time 0 to 24 hours post-dose (AUC0-24) for motesanib in Cycle 2 calculated using the using the linear/log trapezoidal method. For the 75 mg BID cohort AUC0-24 is the sum of AUC0-12 for the first and second daily dose.
Trough Plasma Concentration at 24 Hours Post-dose (C24) for Motesanib in Cycle 2
Time frame: Cycle 2, Day 1, 24 hours post-dose
The trough plasma concentration for motesanib at 24 hours postdose in Cycle 2. For the 75 BID cohort, C24 is the observed concentration at 24 hours (ie, after the second daily dose).

1 secondary outcome

Percentage of Participants With an Overall Objective Response
Time frame: After 9 weeks of treatment (at the end of Cycle 3)

Results and safety

Results posted to the registry on 24 Mar 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Paclitaxel/Carboplatin + Motesanib 50 mg QD	9	5
Paclitaxel/Carboplatin + Motesanib 125 mg QD	11	8
Paclitaxel/Carboplatin + Motesanib 75 mg BID	7	4
Panitumumab + Motesanib 50 mg QD	5	4
Panitumumab + Motesanib 125 mg QD	7	3
Panitumumab + Motesanib 75 mg BID	6	3
Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD	6	4

Primary outcome: Time to Maximum Plasma Concentration of Motesanib (Tmax) for Cycle 1

Time frame: Cycle 1, Day 3 at predose, 15 and 30 minutes, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose.. Median (Full Range). Unit: hours

Measure	Paclitaxel/Carboplatin + Motesanib 50 mg QD n = 4	Paclitaxel/Carboplatin + Motesanib 125 mg QD n = 9	Paclitaxel/Carboplatin + Motesanib 75 mg BID n = 6	Panitumumab + Motesanib 50 mg QD n = 4	Panitumumab + Motesanib 125 mg QD n = 6	Panitumumab + Motesanib 75 mg BID n = 3	Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD n = 3
Value	0.75 (0.5 to 2.0)	1.0 (0.5 to 6.0)	0.75 (0.25 to 1.00)	1.5 (0.5 to 4.0)	1.0 (0.5 to 1.0)	0.58 (0.50 to 1.00)	1.0 (1.0 to 4.0)

Population analysed: The pharmacokinetic (PK) population consisted of all consented patients who received motesanib and had evaluable pharmacokinetic data and did not have significant protocol deviations that affected the data or key-dosing information that was missing.

Primary outcome: Maximum Observed Plasma Concentration of Motesanib (Cmax) in Cycle 1

Time frame: Cycle 1, Day 3 at predose, 15 and 30 min, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose.. Mean (Standard Deviation). Unit: ng/mL

Measure	Paclitaxel/Carboplatin + Motesanib 50 mg QD n = 4	Paclitaxel/Carboplatin + Motesanib 125 mg QD n = 9	Paclitaxel/Carboplatin + Motesanib 75 mg BID n = 6	Panitumumab + Motesanib 50 mg QD n = 4	Panitumumab + Motesanib 125 mg QD n = 6	Panitumumab + Motesanib 75 mg BID n = 3	Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD n = 3
Value	158 (55)	525 (250)	448 (112)	328 (214)	444 (130)	198 (55)	360 (243)

Population analysed: PK population

Primary outcome: Estimated Terminal-phase Half-life (t1/2,z) of Motesanib in Cycle 1

Time frame: Cycle 1, Day 3 at predose, 15 and 30 min, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours postdose.. Mean (Standard Deviation). Unit: hours

Measure	Paclitaxel/Carboplatin + Motesanib 50 mg QD n = 3	Paclitaxel/Carboplatin + Motesanib 125 mg QD n = 7	Paclitaxel/Carboplatin + Motesanib 75 mg BID n = 6	Panitumumab + Motesanib 50 mg QD n = 4	Panitumumab + Motesanib 125 mg QD n = 4	Panitumumab + Motesanib 75 mg BID n = 3
Value	7.34 (2.07)	5.33 (1.05)	5.77 (1.45)	6.47 (2.31)	7.57 (2.60)	8.28 (2.62)

Population analysed: PK Population. Participants with elevated motesanib concentrations at 24 hours were excluded from the calculations. Summary results are not presented for the Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD treatment group for which the sample size was smaller than 3.

Primary outcome: Area Under the Plasma Concentration-time Curve for Motesanib in Cycle 1

Time frame: Cycle 1, Day 3 at predose, 15 and 30 minutes, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose.. Mean (Standard Deviation). Unit: μg*hr/mL

Measure	Paclitaxel/Carboplatin + Motesanib 50 mg QD n = 3	Paclitaxel/Carboplatin + Motesanib 125 mg QD n = 7	Paclitaxel/Carboplatin + Motesanib 75 mg BID n = 5	Panitumumab + Motesanib 50 mg QD n = 4	Panitumumab + Motesanib 125 mg QD n = 4	Panitumumab + Motesanib 75 mg BID n = 3
Value	0.971 (0.300)	3.21 (1.12)	2.91 (1.01)	1.74 (0.63)	3.23 (1.83)	2.04 (1.06)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: First dose through 30 days after last dose; maximum time on treatment was 322 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Paclitaxel/Carboplatin + Motesanib 50 mg QD	5 of 6 (83.3%)	6 of 6 (100%)	Not reported
Paclitaxel/Carboplatin + Motesanib 125 mg QD	2 of 11 (18.2%)	11 of 11 (100%)	Not reported
Paclitaxel/Carboplatin + Motesanib 75 mg BID	3 of 6 (50%)	6 of 6 (100%)	Not reported
Panitumumab + Motesanib 50 mg QD	0 of 4 (0%)	4 of 4 (100%)	Not reported
Panitumumab + Motesanib 125 mg QD	1 of 7 (14.3%)	7 of 7 (100%)	Not reported
Panitumumab + Motesanib 75 mg BID	4 of 5 (80%)	5 of 5 (100%)	Not reported
Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD	2 of 6 (33.3%)	6 of 6 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 20028752Blumenschein 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.
AmgenTrials clinical trials websiteLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MD study director

Amgen

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Panitumumab, Motesanib diphosphate and Paclitaxel in people with Lung Cancer and Non-Small Cell Lung Cancer, run by Amgen.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Maximum Plasma Concentration of Motesanib (Tmax) for Cycle 1 (time frame: Cycle 1, Day 3 at predose, 15 and 30 minutes, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00094835, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2016.