Extension Study of EC145 (Vintafolide) for Subjects Enrolled in a Previous Study With EC145 (MK-8109-010)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Endocyte
ClinicalTrials.gov Identifier:
NCT01002924
First received: October 26, 2009
Last updated: October 7, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Solid Tumors
Drug: EC145
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Further study details as provided by Endocyte:

Primary Outcome Measures:
  • Number of participants experiencing adverse events [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
  • Number of participants experiencing serious adverse events [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
  • Number of participants discontinuing study drug due to adverse events [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: December 2009
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: All Participants
All participants invited to enroll on study will receive EC145 (vintafolide) 2.5 mg by intravenous bolus on Monday, Wednesday, and Friday of Weeks 1 and 3 in each 4-week cycle.
Drug: EC145
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01002924

Locations
United States, Maryland
Center for Blood and Cancer Disorders
Bethesda, Maryland, United States, 20817
Sponsors and Collaborators
Endocyte
Investigators
Study Director: Siu-Long Yao Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Endocyte
ClinicalTrials.gov Identifier: NCT01002924     History of Changes
Other Study ID Numbers: 8109-010, EC-FV-05
Study First Received: October 26, 2009
Last Updated: October 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Endocyte:
Cancer
Adenocarcinoma
Phase II
Lung
Non-small cell lung cancer
NSCLC
extension
EC145
Extension
Prior exposure to EC145

ClinicalTrials.gov processed this record on October 23, 2014