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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01666977




Registration number
NCT01666977
Ethics application status
Date submitted
15/08/2012
Date registered
17/08/2012
Date last updated
3/06/2016

Titles & IDs
Public title
Phase 1b/2 Trial of AMG386 With Pemetrexed and Carboplatin in Non-Small Cell Lung Cancer
Scientific title
A Phase 1b/2 Trial of AMG 386 in Combination With Pemetrexed and Carboplatin as First Line Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer
Secondary ID [1] 0 0
2011-001111-31
Secondary ID [2] 0 0
20101128
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AMG 386
Treatment: Drugs - AMG 386
Treatment: Drugs - AMG 386 Placebo
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Carboplatin

Experimental: Arm A - Arm A: AMG 386 placebo IV QW, pemetrexed 500 mg/m2 IV Q3W, carboplatin AUC 6 IV Q3W, for up to 6 cycles

Experimental: Arm B - Arm B: AMG 386 15 mg/kg IV QW, pemetrexed 500 mg/m2 IV Q3W, carboplatin AUC 6 IV Q3W, for up to 6 cycles

Experimental: Arm C - Arm C: AMG 386 30 mg/kg IV QW, pemetrexed 500 mg/m2 IV Q3W, carboplatin AUC 6 IV Q3W, for up to 6 cycles


Treatment: Drugs: AMG 386
15mg/kg

Treatment: Drugs: AMG 386
30 mg/kg

Treatment: Drugs: AMG 386 Placebo
AMG 386 Placebo

Treatment: Drugs: Pemetrexed
Pemetrexed 500 mg/m2

Treatment: Drugs: Carboplatin
Carboplatin AUC 6

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival
Timepoint [1] 0 0
Incidence of adverse events and clinical laboratory abnormalities defined as a DLT

Eligibility
Key inclusion criteria
* Histologically confirmed, unresectable stage IV non-squamous non small cell lung cancer (NSCLC)
* Radiographically evaluable disease (measurable or non-measurable) per RECIST 1.1 with modifications
* Adequate hematological, renal, and hepatic function, normal coagulation profile, calculated CrCL = 45 mL/min
* Other criteria may apply
Minimum age
18 Years
Maximum age
95 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Any prior chemotherapy or targeted therapy for non-squamous NSCLC
* Subjects with adenosquamous histology or any histology subtype containing greater than 10% squamous cells
* Subjects with an epidermal growth factor receptor (EGFR) mutation sensitive to treatment with a tyrosine kinase inhibitor (TKI)
* Subjects with known anaplastic lymphoma kinase (EML4-ALK) translocations
* History or presence of central nervous system metastases
* Central (chest) radiation therapy within 28 days prior to enrollment/randomization, radiation therapy to any other site(s) within 14 days prior to enrollment/randomization
* History of pulmonary hemorrhage or gross hemoptysis within 6 months
* History of arterial or venous thromboembolism within 12 months
* History of clinically significant bleeding within 6 months
* Clinically significant cardiovascular disease within 12 months
* Other criteria may apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Research Site - Camperdown
Recruitment hospital [2] 0 0
Research Site - Kogarah
Recruitment hospital [3] 0 0
Research Site - Randwick
Recruitment hospital [4] 0 0
Research Site - Tweed Heads
Recruitment hospital [5] 0 0
Research Site - Herston
Recruitment hospital [6] 0 0
Research Site - Bentleigh East
Recruitment hospital [7] 0 0
Research Site - Heidelberg
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2031 - Randwick
Recruitment postcode(s) [4] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [5] 0 0
4029 - Herston
Recruitment postcode(s) [6] 0 0
3165 - Bentleigh East
Recruitment postcode(s) [7] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Kentucky
Country [5] 0 0
United States of America
State/province [5] 0 0
New Hampshire
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
North Dakota
Country [8] 0 0
United States of America
State/province [8] 0 0
South Carolina
Country [9] 0 0
Belgium
State/province [9] 0 0
Bruxelles
Country [10] 0 0
Canada
State/province [10] 0 0
Ontario
Country [11] 0 0
Canada
State/province [11] 0 0
Quebec
Country [12] 0 0
Greece
State/province [12] 0 0
Heraklion
Country [13] 0 0
Greece
State/province [13] 0 0
Larissa
Country [14] 0 0
Greece
State/province [14] 0 0
Patra
Country [15] 0 0
Greece
State/province [15] 0 0
Thessaloniki
Country [16] 0 0
Spain
State/province [16] 0 0
Andalucía
Country [17] 0 0
Spain
State/province [17] 0 0
Aragón
Country [18] 0 0
Spain
State/province [18] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this phase 1b/2 study is to estimate the treatment effect of study drug measuring progression free survival.
Trial website
https://clinicaltrials.gov/study/NCT01666977
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01666977