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/ct2/show/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
Treatment: Drugs - pemetrexed

Treatment: Drugs: pemetrexed
Intervention code [1] 0 0
Treatment: Drugs
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
In previous phase 2 studies, pemetrexed has shown antitumor activity in advanced non-small
cell lung cancer as a single agent as well as in combination with cisplatin. Since the
introduction of vitamin supplementation, pemetrexed has shown good tolerance and high safety.
Vitamin supplementation has opened the opportunity to offer patients higher pemetrexed
dosing, as has been demonstrated by a recent Phase 1 study. The higher dose with
supplementation may increase pemetrexed's efficacy without unduly compromising safety. The
present Phase 2 study will use pemetrexed dosing that is tailored to individual patient
tolerance, and is an effort to determine the efficacy and safety of this approach in patients
with advanced NSCLC who had prior chemotherapy.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00190840
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00190840