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


Phase 1
18 Years
N/A
Not Enrolling
Both
Cancer

Thank you

Trial Information

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, 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.


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

Type of Study:

Interventional

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 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:

Yes

Principal Investigator

Richard A. Messmann, MD, MHS, MSc

Investigator Role:

Study Director

Investigator Affiliation:

Endocyte

Authority:

United States: Food and Drug Administration

Study ID:

EC-0225-01

NCT ID:

NCT00441870

Start Date:

February 2007

Completion Date:

November 2010

Related Keywords:

  • Cancer
  • Cancer
  • Phase 1
  • EC0225
  • EC20
  • Refractory
  • Metastatic
  • Experimental

Name

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