Protocol EC-FV-05: An Open-label, Multi-center, Extension Study of EC145 Administered Weeks 1 and 3 of a 4-Week Cycle in Subjects Enrolled in a Previous Study With EC145
18 Years
N/A
Both
Adenocarcinoma of the Lung
Trial Information
Protocol EC-FV-05: An Open-label, Multi-center, Extension Study of EC145 Administered Weeks 1 and 3 of a 4-Week Cycle in Subjects Enrolled in a Previous Study With EC145
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Summary of the frequency of treatment-emergent adverse events and serious adverse events (by CTCAE v3.0 preferred term and system organ class). Summary of laboratory test values with descriptive statistics and analyzed for abnormal changes from baseline.
Outcome Time Frame:
2 years
Safety Issue:
Yes
Principal Investigator
Binh Nguyen, MD
Investigator Role:
Study Director
Investigator Affiliation:
Endocyte
Authority:
United States: Food and Drug Administration
Study ID:
EC-FV-05
NCT ID:
NCT01002924
Start Date:
December 2009
Completion Date:
December 2016
Related Keywords:
- Adenocarcinoma of the Lung
- Cancer
- Adenocarcinoma
- Phase II
- Lung
- Non-small cell lung cancer
- NSCLC
- extension
- EC145
- Extension
- Prior exposure to EC145
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Lung Neoplasms
Name | Location |
|---|---|
| Center for Blood and Cancer Disorders | Bethesda, Maryland 20817 |
