Study of EC0489 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 EC0489 in patients with refractory or metastatic tumors who have exhausted standard therapeutic options.

Key facts

Study ID

NCT00852189

Run by

Endocyte

People needed

65

Starts

2009-04-01

Expected to finish

2012-04-01

Last updated by the study team

2012-08-08

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
• ≥ 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

You may not qualify if…

• 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

Where it is running

• Horizon Oncology Center — Lafayette, Indiana, United States
• Greenebaum Cancer Center - University of Maryland — Baltimore, Maryland, United States
• Center for Cancer and Blood Disorders — Bethesda, Maryland, United States
• Barbara Ann Karmanos Cancer Institute - Wayne State University — Detroit, Michigan, United States
• Great Lakes Cancer Institute - Michigan State University — Lansing, Michigan, United States
• Providence Cancer Institute — Southfield, Michigan, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.