NCT00852189

Brief Summary

This is a Phase 1 clinical trial evaluating the safety and tolerability of escalating doses of EC0489 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
65

participants targeted

Target at P50-P75 for phase_1 cancer

Timeline
Completed

Started Apr 2009

Geographic Reach
1 country

6 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

First Submitted

Initial submission to the registry

February 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 26, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

August 8, 2012

Status Verified

August 1, 2012

Enrollment Period

2.7 years

First QC Date

February 25, 2009

Last Update Submit

August 7, 2012

Conditions

Cancer

Keywords

CancerPhase 1EC0489EC20RefractoryMetastaticExperimental

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

EC0489, InjectionDRUG

PART A: Dose escalation from a starting dose of 1.0 mg/m2 IV bolus on 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
EC20DRUG

20-25 mCi 99mTc-EC20 administered IV bolus 1-2 hours prior to imaging and at end of study for subjects who received 1 cycle or more of EC0489.

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
  • ≥ 4 weeks post therapeutic radiation or recovered (or returned to baseline) from any acute toxicity associated with prior cytotoxic therapy. Patients previously treated with non-cytotoxic therapy (e.g., EGFR, VGEF, etc.) 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 EC0489)and willingness to practice contraceptive methods
  • Adequate bone marrow reserve, renal and hepatic function

You may not qualify if:

  • Concurrent malignancies
  • Women who are pregnant or breast-feeding
  • Evidence of symptomatic brain metastases
  • Receiving concomitant anticancer therapy (excluding supportive care)
  • Requires palliative radiotherapy at time of study entry
  • Requires antifolate therapy for comorbid conditions
  • Heart failure characterized as greater than NYHA Class I
  • History of myocardial infarct
  • Any of the following baseline echocardiogram findings: valvular lesions (stenosis or insufficiency) characterized as greater than moderate, systolic ventricular impairment characterized as greater than mild, left ventricular ejection fraction \< 55%, any feature of the echocardiogram that would confound interpretation of the serial echocardiograms required by the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Horizon Oncology Center

Lafayette, Indiana, 47905, United States

Location

Greenebaum Cancer Center - University of Maryland

Baltimore, Maryland, 21201, United States

Location

Center for Cancer and Blood Disorders

Bethesda, Maryland, 20817, United States

Location

Barbara Ann Karmanos Cancer Institute - Wayne State University

Detroit, Michigan, 48201, United States

Location

Great Lakes Cancer Institute - Michigan State University

Lansing, Michigan, 48910, United States

Location

Providence Cancer Institute

Southfield, Michigan, 48075, United States

Location

MeSH Terms

Conditions

NeoplasmsNeoplasm Metastasis

Interventions

EC 0489

Condition Hierarchy (Ancestors)

Neoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Richard A Messmann, MD, MHS, MSc

    Endocyte

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

February 25, 2009

First Posted

February 26, 2009

Study Start

April 1, 2009

Primary Completion

December 1, 2011

Study Completion

April 1, 2012

Last Updated

August 8, 2012

Record last verified: 2012-08

Locations

US(6)