- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00852189
Study of EC0489 for the Treatment of Refractory or Metastatic Tumors
A Phase I Study of EC0489 Administered Weeks 1 and 3 of a 4-Week Cycle
Study Overview
Status
Conditions
Intervention / Treatment
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 to patients with refractory or metastatic cancer who have exhausted standard therapeutic options. EC0489 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 EC0489; however, lab research (research in test tubes or animals) using EC0489 has shown activity against tumors in animals. This activity in animal models suggests that EC0489 may be useful as chemotherapy against human cancers. The primary objective of this study is to determine the safety and maximum tolerated dose of EC0489 given by intravenous bolus. The efficacy of treatment will also be measured.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Indiana
-
Lafayette, Indiana, United States, 47905
- Horizon Oncology Center
-
-
Maryland
-
Baltimore, Maryland, United States, 21201
- Greenebaum Cancer Center - University of Maryland
-
Bethesda, Maryland, United States, 20817
- Center For Cancer And Blood Disorders
-
-
Michigan
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Detroit, Michigan, United States, 48201
- Barbara Ann Karmanos Cancer Institute - Wayne State University
-
Lansing, Michigan, United States, 48910
- Great Lakes Cancer Institute - Michigan State University
-
Southfield, Michigan, United States, 48075
- Providence Cancer Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
- ≥ 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum tolerated dose (MTD)
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
|
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
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacokinetic and pharmacodynamic parameters
Time Frame: Obtained during the first cycle of therapy on Days 1 and 3
|
Obtained during the first cycle of therapy on Days 1 and 3
|
Anti-tumor activity
Time Frame: Initial dose of study therapy to disease progression
|
Initial dose of study therapy to disease progression
|
Uptake of 99mTc-EC20 in tumors and normal tissues
Time Frame: 1-2 hours post administration of 99mTc-EC20
|
1-2 hours post administration of 99mTc-EC20
|
Safety and Tolerability
Time Frame: Initiation of study therapy through 30 day post last dose of study therapy
|
Initiation of study therapy through 30 day post last dose of study therapy
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Richard A Messmann, MD, MHS, MSc, Endocyte
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EC-0489-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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