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

NCT01002924 | Completed Phase 2 FDA Drug

• 2 other identifiers: 8109-010EC-FV-05
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumors

Keywords

Cancer; Adenocarcinoma; Phase II; Lung; Non-small cell lung cancer; NSCLC; extension; EC145; Prior exposure to EC145

Outcome Measures

Primary Outcomes (3)

• Number of participants experiencing adverse events

  Up to 2 years

• Number of participants experiencing serious adverse events

  Up to 2 years

• Number of participants discontinuing study drug due to adverse events

  Up to 2 years

Study Arms (1)

All Participants

EXPERIMENTAL

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

Interventions

EC145 DRUG

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.

All Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Endocyte: lead

Study Sites (1)

Center for Blood and Cancer Disorders

Bethesda, Maryland, 20817, United States

Location

MeSH Terms

Conditions

Neoplasms; Adenocarcinoma; Carcinoma, Non-Small-Cell Lung

Interventions

EC145

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Siu-Long Yao

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2009
• First Posted: October 28, 2009
• Study Start: December 31, 2009
• Primary Completion: December 11, 2013
• Study Completion: December 11, 2013
• Last Updated: April 8, 2021

Record last verified: 2021-04

Locations

US (1)