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Extension Study of EC145 for Subjects Enrolled in a Previous Study With EC145

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: March 5, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Adenocarcinoma of the Lung
 Drug: EC145
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Endocyte:

Primary Outcome Measures:
  • 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. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: December 2009
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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: Binh Nguyen, MD Endocyte
  More Information

No publications provided

Responsible Party: Endocyte
ClinicalTrials.gov Identifier: NCT01002924     History of Changes
Other Study ID Numbers: EC-FV-05
Study First Received: October 26, 2009
Last Updated: March 5, 2012
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

Additional relevant MeSH terms:
Adenocarcinoma
Adenocarcinoma, Mucinous
Lung Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Neoplasms, Cystic, Mucinous, and Serous
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 22, 2013