Clinical trial NCT01002924: Extension Study of EC145 (Vintafolide) for Subjects Enrolled in a Previous Study With EC145 (MK-8109-010)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Solid Tumors
Keywords: Cancer
Adenocarcinoma
Phase II
Lung
Non-small cell lung cancer
NSCLC
extension
EC145
Prior exposure to EC145
Lead sponsor: Endocyte
Sponsor class: INDUSTRY
First posted: 2009-10-28
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants experiencing adverse events
timeFrame: Up to 2 years
measure: Number of participants experiencing serious adverse events
timeFrame: Up to 2 years
measure: Number of participants discontinuing study drug due to adverse events
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Center for Blood and Cancer Disorders
state: Maryland
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Siu-Long Yao
role: STUDY_DIRECTOR
References: