Status:
COMPLETED
Study of EC0489 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 EC0489 in patients with refractory or metastatic tumors who have exhausted standard therapeutic options.
Detailed Description
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 ...
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
- ≥ 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
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00852189
Start Date
April 1 2009
End Date
April 1 2012
Last Update
August 8 2012
Active Locations (6)
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1
Horizon Oncology Center
Lafayette, Indiana, United States, 47905
2
Greenebaum Cancer Center - University of Maryland
Baltimore, Maryland, United States, 21201
3
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States, 20817
4
Barbara Ann Karmanos Cancer Institute - Wayne State University
Detroit, Michigan, United States, 48201