Study of EC0225 for the Treatment of Refractory or Metastatic Tumors

Completed · Phase 1

Conditions studied: Cancer

In brief

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.

Key facts

Study ID

NCT00441870

Run by

Endocyte

People needed

77

Starts

2007-02-01

Expected to finish

2010-11-01

Last updated by the study team

2012-03-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

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

Where it is running

• Greenebaum Cancer Center - University of Maryland Medicine — Baltimore, Maryland, United States
• Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States
• Nevada Cancer Institute — Las Vegas, Nevada, United States

Full record on ClinicalTrials.gov

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