Status:
TERMINATED
A Phase 1 Continuous Intravenous Infusion Study of Terameprocol (EM-1421) in Subjects With Refractory Solid Tumors
Lead Sponsor:
Erimos Pharmaceuticals
Conditions:
Refractory Solid Tumors
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a Phase I continuous infusion study designed to explore if constant concentration over time adds to the effectiveness of terameprocol without increasing toxicity. It will also explore weekly d...
Detailed Description
Subjects meeting all inclusion and exclusion criteria will be enrolled to receive terameprocol as a weekly 24 hour intravenous infusion, three weeks out of four. Serial measurements of safety will be ...
Eligibility Criteria
Inclusion
- Male or female subjects greater than or equal to 18 years of age.
- Subjects who have provided written informed consent to participate in the study.
- Subjects with documented evidence of cancer with clinically measurable or evaluable disease. Cancer can be recurrent after primary treatment with surgery, radiation therapy and/or chemotherapy and may include those subjects for whom no standard or curative therapy exists.
- Measurable tumor by imaging (CT per RECIST criteria). unless an established tumor marker exists which can be used for assessment of response in the absence of measurable disease (i.e., PSA in prostate cancer or CA 125 in ovarian cancer).
- No recent myocardial infarction (within 3 months) or serious intercurrent cardiovascular disease (any event that requires evaluation by a cardiologist, with a definitive cardiac disease diagnosed) Subjects with a history of severe cardiac disease should have had a recent consultation with a cardiologist documenting that there are no new findings.
- No overt cardiac metastasis.
- Negative pregnancy test if in women of childbearing potential within one week of starting therapy.
- ECOG Performance Status of 0, 1, or 2.
- Absolute neutrophil greater than or equal to 1500 cells/uL, hemoglobin greater than or equal to 9 gm/dl, platelets greater than or equal to 100,000/uL, ALT/AST less than or equal to 3 x ULN (upper limit of the normal range) unless involved with tumor then less than 5 x ULN, bilirubin less than or equal to 1.5 x ULN, creatinine less than or equal to 1.5 x ULN, normal creatinine clearance greater than 60 mL/min and a normal serum bicarbonate. Normal is defined by local laboratory specifications.
Exclusion
- Subjects meeting any of the following criteria will not be considered eligible for participation in the study:
- Women who are pregnant or breast-feeding (women of child-bearing potential must have a negative serum pregnancy test within one week of entering the study).
- Women of child-bearing potential who are unwilling to use two medically acceptable forms of contraception during the course of the study (surgical sterilization, approved hormonal contraceptives, or barrier method with spermicide).
- Subjects unable to comply with the study requirements.
- Subjects with a known sensitivity to any of the study medication components.
- Subjects exhibiting any of the following: a marked baseline prolongation of QT/QTc interval (repeated demonstration of a calculated QTc interval \>450), a history of additional risk factors for TdP (e.g. heart failure, hypokalemia, family history of long QT Syndrome), and subjects unable or unwilling to refrain from using medications that are known to prolong the QT/QTc ratio during the course of the study. Subjects having recently taken such medications must have five half-lives off medication before participation.
- Subjects with an existing port not compatible with the terameprocol formulation.
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00664586
Start Date
May 1 2007
End Date
June 1 2009
Last Update
February 23 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Sarah Cannon Cancer Center
Nashville, Tennessee, United States, 37203