Study of EC0225 for the Treatment of Refractory or Metastatic Tumors

March 8, 2012 updated by: Endocyte

Protocol EC-0225-01: A Phase 1 Study of EC0225 Administered Weeks 1 and 3 of a 4-Week Cycle

This is a Phase 1 clinical trial evaluating the safety and tolerability of escalating doses of EC0225 in patients with refractory or metastatic tumors who have exhausted standard therapeutic options.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a Phase 1, dose escalation study of EC0225 administered by intravenous bolus (IV) during weeks 1 and 3 of a 4-week cycle to patients with refractory or metastatic cancer who have exhausted standard therapeutic options. EC0225 is a drug that is specifically designed to enter cells via a folate vitamin receptor. Experimental evidence shows that the target receptor is over-expressed in many human cancers. There are no previous human studies of EC0225; however, lab research (research in test tubes or animals) using EC0225 has shown activity against tumors in animals. This activity in animal models suggests that EC0225 may be useful as chemotherapy against human cancers. The primary objective of this study is to determine the safety and maximum tolerated dose of EC0225 given by intravenous bolus. The efficacy of treatment will also be measured.

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Greenebaum Cancer Center - University of Maryland Medicine
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Barbara Ann Karmanos Cancer Institute
    • Nevada
      • Las Vegas, Nevada, United States, 89135
        • Nevada Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years of age or older
  • Histological or cytological diagnosis of neoplasm
  • No effective standard therapeutic options
  • ECOG performance status of 0-2
  • ≥ to 4 weeks post therapeutic radiation or chemotherapy(≥ to 6 weeks for nitrosureas) and recovery (to baseline status) from associated acute toxicities. Patients previously treated with non-cytotoxic therapy and who have recovered from or have controlled drug-associated toxicity are allowed to enter the trial after a period consisting of 4 half-lives of the agent.
  • Negative serum pregnancy test for women of child-bearing potential within one week prior to treatment with investigational agents (99mTc-EC20 and EC0225)
  • Adequate bone marrow reserve, renal and hepatic function

Exclusion Criteria:

  • Concurrent malignancies
  • Women who are pregnant or lactating
  • Evidence of symptomatic brain metastases
  • Receiving concomitant anticancer therapy (excluding supportive care)
  • Requires palliative radiotherapy at time of study entry
  • Unable to tolerate conditions for radionuclide imaging
  • Administration of another radiopharmaceutical that would interfere with assessment of 99mTc-EC20

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum tolerated dose (MTD)
Time Frame: Dose escalation to the highest dose that can be safely administered to produce acceptable, manageable and reversible toxicity in no more than 0 or 1 of 6 patients
Dose escalation to the highest dose that can be safely administered to produce acceptable, manageable and reversible toxicity in no more than 0 or 1 of 6 patients

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic and pharmacodynamic parameters
Time Frame: Obtained during the first cycle of therapy on Days 1 and 3
Obtained during the first cycle of therapy on Days 1 and 3
Anti-tumor activity
Time Frame: Initial dose of study therapy to disease progression
Initial dose of study therapy to disease progression
Uptake of 99mTc-Ec20 in tumors and normal tissues
Time Frame: 1-2 hours post-administration of 99mTc-EC20
1-2 hours post-administration of 99mTc-EC20
Safety and tolerability
Time Frame: Initiation of study therapy through 30 day post last dose of study therapy
Initiation of study therapy through 30 day post last dose of study therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Endocyte

Investigators

  • Study Director: Richard A. Messmann, MD, MHS, MSc, Endocyte

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

February 27, 2007

First Submitted That Met QC Criteria

February 27, 2007

First Posted (Estimate)

March 1, 2007

Study Record Updates

Last Update Posted (Estimate)

March 9, 2012

Last Update Submitted That Met QC Criteria

March 8, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC-0225-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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