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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01002924
First Posted: October 28, 2009
Last Update Posted: August 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Endocyte
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]
  • Number of participants experiencing serious adverse events [ Time Frame: Up to 2 years ]
  • Number of participants discontinuing study drug due to adverse events [ Time Frame: Up to 2 years ]

Enrollment: 1
Study Start Date: December 2009
Study Completion Date: December 11, 2013
Primary Completion Date: December 11, 2013 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Endocyte
ClinicalTrials.gov Identifier: NCT01002924     History of Changes
Other Study ID Numbers: 8109-010
EC-FV-05
First Submitted: October 26, 2009
First Posted: October 28, 2009
Last Update Posted: August 24, 2017
Last Verified: August 2017

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

Additional relevant MeSH terms:
Folic Acid
Vinca Alkaloids
Hematinics
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action