Status:
COMPLETED
Study of EC0225 for the Treatment of Refractory or Metastatic Tumors
Lead Sponsor:
Endocyte
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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.
Detailed Description
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 sta...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT00441870
Start Date
February 1 2007
End Date
November 1 2010
Last Update
March 9 2012
Active Locations (3)
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1
Greenebaum Cancer Center - University of Maryland Medicine
Baltimore, Maryland, United States, 21201
2
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
3
Nevada Cancer Institute
Las Vegas, Nevada, United States, 89135