NCT00441870

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P75+ for phase_1 cancer

Timeline
Completed

Started Feb 2007

Typical duration for phase_1 cancer

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 1, 2007

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

March 9, 2012

Status Verified

March 1, 2012

Enrollment Period

3.8 years

First QC Date

February 27, 2007

Last Update Submit

March 8, 2012

Conditions

Cancer

Keywords

CancerPhase 1EC0225EC20RefractoryMetastaticExperimental

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated dose (MTD)

    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 Outcomes (4)

  • Pharmacokinetic and pharmacodynamic parameters

    Obtained during the first cycle of therapy on Days 1 and 3

  • Anti-tumor activity

    Initial dose of study therapy to disease progression

  • Uptake of 99mTc-Ec20 in tumors and normal tissues

    1-2 hours post-administration of 99mTc-EC20

  • Safety and tolerability

    Initiation of study therapy through 30 day post last dose of study therapy

Interventions

EC0225, for Injection (Folic acid desacetylvinblastine hydrazide conjugate)DRUG

Dose escalation from a starting dose of 0.38mg IV bolus Monday Wednesday and Friday Weeks 1 and 3 of a 4 Week Cycle to the Maximum Tolerated Dose (MTD)

Also known as: Folic acid desacetylvinblastine hydrazide conjugate
99mTC-EC20 (Folic acid-technetium 99m conjugate)DRUG

20-25 mCi 99m Tc-EC20 administered IV 1-2 hours prior to imaging

Also known as: Folic acid-technetium 99m conjugate, FolateScan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Greenebaum Cancer Center - University of Maryland Medicine

Baltimore, Maryland, 21201, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Nevada Cancer Institute

Las Vegas, Nevada, 89135, United States

Location

MeSH Terms

Conditions

NeoplasmsNeoplasm Metastasis

Interventions

EC0225WW Domain-Containing Oxidoreductase

Condition Hierarchy (Ancestors)

Neoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Short Chain Dehydrogenase-ReductasesNAD (+) and NADP (+) Dependent Alcohol OxidoreductasesAlcohol OxidoreductasesOxidoreductasesEnzymesEnzymes and CoenzymesTumor Suppressor ProteinsNeoplasm ProteinsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Richard A. Messmann, MD, MHS, MSc

    Endocyte

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2007

First Posted

March 1, 2007

Study Start

February 1, 2007

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

March 9, 2012

Record last verified: 2012-03

Locations

US(3)