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Protocol EC-FV-01: A Phase 1 Study of EC145 Administered in Weeks 1 and 3 of a 4-Week Cycle

Phase 1
18 Years
Not Enrolling

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Trial Information

Protocol EC-FV-01: A Phase 1 Study of EC145 Administered in Weeks 1 and 3 of a 4-Week Cycle

This is a Phase I, dose escalation study of EC145 administered by intravenous bolus (IV)
during weeks 1 and 3 of a 4-week cycle to patients with solid tumors refractory to current
therapies. EC145 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 EC145 treatment; however, lab
research (research in test tubes and/or animals) using EC145 has shown activity against
tumors in animals. This activity in animal models suggests that EC145 may be useful as
chemotherapy against human cancers.

The primary objective of this study is to determine the safety and maximum tolerated dose of
EC145 given by intravenous bolus. The efficacy of the 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

- > or = to 4 weeks post therapeutic radiation of chemotherapy (> or = to 6 weeks for
nitrosoureas and mitomycin C) and recovery from associated toxicities

- Negative serum pregnancy test for women of child-bearing potential and willingness to
practice contraceptive methods

- Adequate bone marrow reserve, renal, and hepatic function

Exclusion Criteria:

- Concurrent hematological 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

Type of Study:


Study Design:

Allocation: Non-Randomized, 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 hightest 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, BSc

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

March 2006

Completion Date:

July 2008

Related Keywords:

  • Cancer
  • Cancer
  • Phase I
  • EC145
  • Recurrent
  • Refractory
  • Solid Tumors
  • Experimental



Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
Greenebaum Cancer Center at University of Maryland Medical Center Baltimore, Maryland  21201