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Pemetrexed- Before Protocol Amendment

Phase 2

Non Small Cell Lung Cancer | Small molecule | Oncology |Eli Lilly and Company|Last Updated: Oct 20, 2009

Target and mechanism

ModalitySmall molecule

Also known as Pemetrexed - Before Protocol Amendment

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment19

FDA Designations

No designations recorded

Clinical trial landscape

Pemetrexed- Before Protocol Amendment · 1 trial · 1 indication

Phase 2 1
NCT00370292Dosage Schedule Study of Pemetrexed Monochemotherapy for Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)Non Small Cell Lung Cancer
COMPLETED19 Analytics
PHASE2COMPLETED
Dosage Schedule Study of Pemetrexed Monochemotherapy for Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Non Small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Mean Deoxycytidine Kinase (dCK) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3
pre-dose, 1, 2, 4, 6, 24, and 48 hours post-dose (3 cycles)

dCK and hENT expression (see Outcome #2) on normal lymphocytes were measured after Pemetrexed administration to evaluate if there was reproducible timing of maximum dCK expression, and to assess proper time interval between pemetrexed and gemcitabine for treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC). Values are calculated as ratio between thereshold cycles (number of polymerase chain reaction \[PCR\] cycles) with respect to a reference gene; in this case glyceraldehyde 3-phosphate dehydrogenase (GAPDH).

Mean Human Equilibrative Nucleoside Transporter 1 (hENT) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3
pre-dose, 1, 2, 4, 6, 24, and 48 hours post-dose (3 cycles)

dCK (see Outcome #1)and hENT expression (see Outcome #2) on normal lymphocytes were measured after Pemetrexed administration to evaluate if there was reproducible timing of maximum dCK expression, and to assess proper time interval between pemetrexed and gemcitabine for treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC). Values are calculated as ratio between thereshold cycles (number of polymerase chain reaction \[PCR\] cycles) with respect to a reference gene; in this case glyceraldehyde 3-phosphate dehydrogenase (GAPDH).

Secondary Endpoints

Best Objective Tumor Response
baseline to measured response (every 14 days for 6 cycles)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Pemetrexed - Before Protocol AmendmentEXPERIMENTAL -
Pemetrexed - After Protocol AmendmentEXPERIMENTAL -

Interventions

NameTypeDescription
Pemetrexed - Before Protocol AmendmentDRUG500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles or disease progression, unacceptable toxicity or patient decision to discontinue
Pemetrexed - After Protocol AmendmentDRUG500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 6 cycles or disease progression, unacceptable toxicity or patient decision to discontinue.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria * Histologically or cytologically proven IIIB and IV NSCLC. * No symptomatic uncontrolled brain metastasis * Not suitable for platinum containing regimens if chemo-naive * Performance status less than or equal to 2 on the Eastern Cooperative Oncology Group (ECOG) Scale. * Creatin...

Countries:Italy
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Competitive Landscape -Non-Small Cell Lung Cancer 387 trials (matched to "Non Small Cell Lung Cancer")