Phase 2
N=52
Study of LY573636-Sodium in Patients With Metastatic Non-Small Cell Lung Cancer
Non-Small-Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00363766 ↗Enrolled (actual)
52
Serious AEs
50.0%
Results posted
Oct 2018
Primary outcome: Primary: Time to Progression — 3.12; 1.64 months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LY573636-sodium (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Progression |
3.12; 1.64 | — |
| SECONDARY Progression-Free Survival |
2.69; 1.43 | — |
| SECONDARY Percentage of Participants With Complete Response or Partial Response (Objective Response Rate) |
0; 0 | — |
| SECONDARY Pharmacokinetics: Maximum Concentration (Cmax) of LY573636 |
379.6; 337.6; 293.7; 316.1 | — |
| SECONDARY Overall Survival Time |
8.48; 7.97 | — |
| SECONDARY Duration of Response |
— | — |
| SECONDARY Duration of Stable Disease |
4.21; 4.93 | — |
| SECONDARY Number of Participants With Adverse Events (Safety) |
17; 9; 30; 17 | — |
Summary
The primary objective is to estimate the time to progressive disease for patients who receive LY573636-sodium (hereafter referred to as LY573636) after two previous treatments for metastatic non-small cell lung cancer. Patients will receive an intravenous infusion of study drug once every 21 days. Computed tomography (CT)-scans will be done before the first dose and then after every other treatment.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of metastatic non-small-cell lung cancer
- At least 18 years of age
- Have received 2 previous treatment regimens for metastatic non-small-cell lung cancer
Exclusion Criteria
- Serious pre-existing medical conditions
- Previous cancer (except skin cancer, excluding melanoma)
- Have received 3 or more previous treatment regimens for metastatic non- small-cell lung cancer
- Active treatment with Coumadin
Data sourced from ClinicalTrials.gov (NCT00363766). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.