Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00190840




Registration number
NCT00190840
Ethics application status
Date submitted
12/09/2005
Date registered
19/09/2005
Date last updated
26/01/2007

Titles & IDs
Public title
A Single Arm Phase 2 Study of Pemetrexed as 2nd-Line Treatment of Advanced Non-Small Cell Lung Cancer
Scientific title
Open-Label Single-Arm Phase 2 Study of ALIMTA in Patients With Advanced Non-Small Cell Lung Cancer Who Have Had Prior Chemotherapy
Secondary ID [1] 0 0
H3E-AA-S037
Secondary ID [2] 0 0
6685
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Response rate according to RECIST criteria
Timepoint [1] 0 0
Secondary outcome [1] 0 0
To assess the following time to event efficacy variables:
Timepoint [1] 0 0
Secondary outcome [2] 0 0
o Duration of overall response for responding patients
Timepoint [2] 0 0
Secondary outcome [3] 0 0
o Time to progressive disease
Timepoint [3] 0 0
Secondary outcome [4] 0 0
o Time to treatment failure
Timepoint [4] 0 0
Secondary outcome [5] 0 0
o Survival
Timepoint [5] 0 0
Secondary outcome [6] 0 0
To characterize the quantitative and qualitative toxicity of pemetrexed when used at tailored dosing in this patient population
Timepoint [6] 0 0

Eligibility
Key inclusion criteria
* diagnosis of NSCLC
* Locally advanced or metastatic disease (Stage IIIB or IV).
* Patients must have previously received one chemotherapy regimen for palliative therapy of locally advanced or metastatic disease.
* Disease status must be that of measurable disease as defined by RECIST criteria
* Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Scale; and adequate organ function.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Known or suspected brain metastasis, or Second primary malignancy that is clinically detectable at the time of consideration for study enrollment
* Concurrent administration of any other tumor therapy.
* History of significant neurological or mental disorder, including seizures or dementia; or any other serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study
* Inability to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) 2 days before, the day of, and 2 days after the dose of pemetrexed.
* Inability or unwillingness to take folic acid, vitamin B12 supplementation, or dexamethasone

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
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
1/09/2003
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,SA,VIC
Recruitment hospital [1] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Wollongong
Recruitment hospital [2] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Chermside
Recruitment hospital [3] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Ashford
Recruitment hospital [4] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Fitzroy
Recruitment postcode(s) [1] 0 0
2500 - Wollongong
Recruitment postcode(s) [2] 0 0
4032 - Chermside
Recruitment postcode(s) [3] 0 0
5035 - Ashford
Recruitment postcode(s) [4] 0 0
3065 - Fitzroy
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Hong Kong
Country [2] 0 0
Egypt
State/province [2] 0 0
Alexandria
Country [3] 0 0
Egypt
State/province [3] 0 0
Cairo
Country [4] 0 0
India
State/province [4] 0 0
Andhra Pradesh
Country [5] 0 0
India
State/province [5] 0 0
Punjab
Country [6] 0 0
India
State/province [6] 0 0
Chandigarh
Country [7] 0 0
India
State/province [7] 0 0
Chennai
Country [8] 0 0
India
State/province [8] 0 0
Delhi
Country [9] 0 0
Korea, Republic of
State/province [9] 0 0
Gyeonggi-Do
Country [10] 0 0
Korea, Republic of
State/province [10] 0 0
Seoul
Country [11] 0 0
Romania
State/province [11] 0 0
Bihor
Country [12] 0 0
Romania
State/province [12] 0 0
Dolj
Country [13] 0 0
Romania
State/province [13] 0 0
Bucuresti
Country [14] 0 0
Romania
State/province [14] 0 0
Iasi
Country [15] 0 0
Taiwan
State/province [15] 0 0
Taipei
Country [16] 0 0
Turkey
State/province [16] 0 0
Eskisehir

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST)
Address 0 0
Eli Lilly and Company
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00190840