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A Phase I Study of EC0489 Administered Weeks 1 and 3 of a 4-Week Cycle

Phase 1
18 Years
Not Enrolling

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Trial Information

A Phase I Study of EC0489 Administered Weeks 1 and 3 of a 4-Week Cycle

This is a Phase 1, dose escalation study of EC0489 administered by intravenous bolus (IV)
during weeks 1 and 3 of a 4-week cycle in PART A and weekly on a 4-week cycle in PART B.

Both Parts are open to patients with refractory or metastatic cancer who have exhausted
standard therapeutic options. EC0489 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 EC0489;
however, lab research (research in test tubes or animals) using EC0489 has shown activity
against tumors in animals. This activity in animal models suggests that EC0489 may be useful
as chemotherapy against human cancers. The primary objective of this study is to determine
the safety and maximum tolerated dose of EC0489 given by intravenous bolus. The efficacy of
treatment will also be measured.

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

- ≥ 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

Exclusion Criteria:

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose (MTD)

Outcome 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

Safety Issue:


Principal Investigator

Richard A Messmann, MD, MHS, MSc

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

April 2009

Completion Date:

April 2012

Related Keywords:

  • Cancer
  • Cancer
  • Phase 1
  • EC0489
  • EC20
  • Refractory
  • Metastatic
  • Experimental



Providence Cancer InstituteSouthfield, Michigan  48075
Center for Cancer and Blood DisordersBethesda, Maryland  20817
Horizon Oncology CenterLafayette, Indiana  47905
Greenebaum Cancer Center - University of MarylandBaltimore, Maryland  21201
Barbara Ann Karmanos Cancer Institute - Wayne State UniversityDetroit, Michigan  48201
Great Lakes Cancer Institute - Michigan State UniversityLansing, Michigan  48910