A Phase 1 Continuous Intravenous Infusion Study of Terameprocol (EM-1421) in Subjects With Refractory Solid Tumors.
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 performed prior to dosing. Subjects will be screened within
28 days of Cycle 1. Hematologic, serum chemistry, tumor marker, and pregnancy testing will
be performed. Circulating tumor cell assays will be performed. Needle biopsy specimens will
be taken prior to therapy and one week after first dose, if possible, to assess for tumor
markers (cdc-2 and survivin). Subjects meeting all inclusion and exclusion criteria will be
enrolled in groups of 3-6 subjects to receive terameprocol as a weekly 24 hour intravenous
infusion. The terameprocol dose levels to be studied include 100mg/hr, increasing by 25 mg/
hr increments in the next cohort assuming no DLT is reached. Serial measurements of safety
will be performed at each visit. The MTD will be assessed after the first Cycle of
treatment at a dose level. The use of myeloid colony-stimulating factors will not be
allowed prophylactically in cycle 1 but may be used if clinically indicated and will be
allowed during subsequent cycles to prevent the development of neutropenia in subjects with
an established history of this adverse event in earlier cycles. Each subject in a cohort
will be treated at the same dose and on the same schedule of weekly infusions. Dose
escalation in a subject may be allowed after safe evaluation of a higher dosage, and two
cycles being completed with stable disease or better.
Terameprocol (EM-1421) will be administered as an intravenous infusion over 24 hours,
weekly. Dose will commence in the first cohort with 100 mg per hour (2400 mg in a 24 hour
period)with escalation in the 5 cohorts of 3 to 6 patients with increments of 25 mg per hour
to a maximum of 200 mg/hr (4800 mg/24 hour period) or until MTD is defined. When the MTD has
been declared, then 11 additional subjects will be enrolled at the MTD dose level (to total
14 subjects treated in dosage cohort).
Cohort A. will receive weekly Terameprocol 100 mg per hour (2400 mg in a 24 hour period)
Cohort B. will receive weekly Terameprocol 125 mg per hour (3000 mg in a 24 hour period)
Cohort C. will receive weekly Terameprocol 150 mg per hour (3600 mg in a 24 hour period)
Cohort D. will receive weekly Terameprocol 175 mg per hour (4200 mg in a 24 hour period)
Cohort E. will receive weekly Terameprocol 200 mg per hour (4800 mg in a 24 hour period)
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine Maximum Tolerated Dose (MTD)and dose limiting toxicities (DLTs) of Terameprocol (EM-1421) administered as a weekly continuous infusion over 24 hours.
The MTD will be assessed after the first Cycle of study drug treatment
Yes
Neil Frazer, MB, ChB
Erimos Pharmaceuticals
United States: Food and Drug Administration
EM-1421 #104
NCT00664586
May 2007
April 2009
Name | Location |
---|---|
The Sarah Cannon Cancer Center | Nashville, Tennessee 37203 |