Trial Outcomes & Findings for S1300: Pemetrexed Disodium With or Without Crizotinib in Treating Patients With Stage IV Non-Small Cell Lung Cancer That Has Progressed After Crizotinib (NCT NCT02134912)
NCT ID: NCT02134912
Last Updated: 2020-02-20
Results Overview
A stratified log-rank test at the 0.10 level will be used to test the primary hypothesis comparing the two treatment arms.
TERMINATED
PHASE2
1 participants
From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 3 years
2020-02-20
Participant Flow
There is only one patient enrolled in this study. Patient was taken off study treatment by treating physician due to recent changes in standard of care. And patient never started protocol treatment. Thus we didn't enter any results for this only patient in the trial.
Participant milestones
| Measure |
Arm I (Crizotinib, Pemetrexed Disodium)
Patients receive crizotinib PO BID on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.
crizotinib: Given PO
pemetrexed disodium: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
Arm II (Pemetrexed Disodium)
ARM II: Patients receive pemetrexed disodium IV over 10 minutes on day 1. Upon disease progression or symptomatic deterioration, patients may crossover to Arm I.
pemetrexed disodium: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
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Overall Study
STARTED
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0
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0
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Overall Study
COMPLETED
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0
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0
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Overall Study
NOT COMPLETED
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
S1300: Pemetrexed Disodium With or Without Crizotinib in Treating Patients With Stage IV Non-Small Cell Lung Cancer That Has Progressed After Crizotinib
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 3 yearsPopulation: The one patient that enrolled immediately withdrew consent \[enrolled the day before the study closed\]. No manuscript will be forthcoming.
A stratified log-rank test at the 0.10 level will be used to test the primary hypothesis comparing the two treatment arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: The one patient that enrolled immediately withdrew consent \[enrolled the day before the study closed\]. No manuscript will be forthcoming.
Comparisons of toxicities rates will be done using a Fisher's exact or chi-squared test of independence, when appropriate using 10% as the significance threshold. Within each treatment arm, any toxicity with at least 5% prevalence has at least a 95% chance of being observed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: The one patient that enrolled immediately withdrew consent \[enrolled the day before the study closed\]. No manuscript will be forthcoming.
Comparisons of response rates will be done using a chi-square test of independence using 10% as the significance threshold. Within each treatment arm, response rates can be estimated to within 13% (with 95% confidence).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: The one patient that enrolled immediately withdrew consent \[enrolled the day before the study closed\]. No manuscript will be forthcoming.
Comparisons of response rates will be done using a chi-square test of independence using 10% as the significance threshold. Within each treatment arm, response rates can be estimated to within 13% (with 95% confidence).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: The one patient that enrolled immediately withdrew consent \[enrolled the day before the study closed\]. No manuscript will be forthcoming.
Defined as CNS-only, extra-CNS, and both CNS and extra-CNS progression between the treatment arms. Evaluated within each treatment arm using cumulative incidence curves.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: The one patient that enrolled immediately withdrew consent \[enrolled the day before the study closed\]. No manuscript will be forthcoming.
Differences in OS by treatment arm will be evaluated using a 1-sided log-rank test with significant level of 10%.
Outcome measures
Outcome data not reported
Adverse Events
Arm I (Crizotinib, Pemetrexed Disodium)
Arm II (Pemetrexed Disodium)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60