Solid Tumors
Conditions
Keywords
Cancer, Adenocarcinoma, Phase II, Lung, Non-small cell lung cancer, NSCLC, extension, EC145, Prior exposure to EC145
Brief summary
This extension protocol is for those subjects that have completed the allowed duration of participation in an Endocyte-sponsored clinical trial of EC145 (vintafolide) and have continuing evidence of clinical benefit (stable disease or better) at the time that they completed participation in that study.
Detailed description
This extension protocol is for those subjects that have completed the allowed duration of participation in an Endocyte-sponsored clinical trial of EC145 and have continuing evidence of clinical benefit (stable disease or better) at the time that they completed participation in that study. Following confirmation of eligibility, subjects will receive intravenously-administered EC145 at a dose of 2.5 mg. Dosing will occur on Monday, Wednesday, and Friday of weeks 1 and 3 of each 4-week cycle. No therapy will be administered during weeks 2 and 4. Subjects randomized to non-EC145-containing treatment arms of EC145 trials are not eligible for this study.
Interventions
DRUGEC145
EC145 will be administered intravenously at a dose of 2.5 mg. Dosing will occur on Monday, Wednesday, and Friday of weeks 1 and 3 of each 4-week cycle. No therapy will be administered during weeks 2 and 4.
Sponsors
Endocyte
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must have received prior treatment with EC145 within the context of an Endocyte-sponsored, IRB-approved clinical trial. * Disease (i.e., cancer) that was considered stable at the last evaluation while participating in the previous EC145-containing study. Stable is defined as not having progression of disease per standard criteria (RECIST, etc). Stable disease may be indicated by previously attained complete or partial tumor shrinkage that has not progressed per standard criteria. * No more than 10 weeks have elapsed since the last evaluation of stable disease. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 * Must have recovered (to baseline/stabilization) from prior EC145-associated acute toxicities. * Adequate bone marrow reserve, hepatic, and renal function. * Negative serum pregnancy test for women of childbearing potential * Willingness to practice contraceptive methods for men and women of childbearing potential.
Exclusion criteria
* Pregnancy. * Development of a secondary malignancy requiring treatment. * Symptomatic central nervous system (CNS) metastasis. * History of receiving any investigational treatment or other systemic therapy directed at controlling cancer since the subject's last dose on the parent EC145 study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants experiencing adverse events | Up to 2 years |
| Number of participants experiencing serious adverse events | Up to 2 years |
| Number of participants discontinuing study drug due to adverse events | Up to 2 years |
Countries
United States
Outcome results
None listed