Study of Oral Clofarabine Administered Daily for 5 Days in Adult Patients With Refractory Solid Tumors

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

October 31, 2003

Primary Completion Date

October 31, 2004

Study Completion Date

February 28, 2006

Conditions
Solid Tumors
Interventions
DRUG

clofarabine (oral formulation)

Cohorts of 3 patients each were to receive oral clofarabine administered daily for 5 days followed by 23 days of rest (1 cycle) and repeated every 28 days depending on toxicity and response. The starting dose of clofarabine was to be 1 mg/m2/day with subsequent dose escalation to occur in increments of 50% for the first 5 dose levels (1.5, 2.25, 3.5, and 5.0 mg/m2/day) and in increments of 25% thereafter until the MTD/RP2D was determined.

Trial Locations (3)

75246

Mary Crowley Medical Research Center, Dallas

75702

Tyler Cancer Institute, Tyler

99218

Cancer Care Northwest, Spokane

All Listed Sponsors
lead

Genzyme, a Sanofi Company

INDUSTRY

NCT00125827 - Study of Oral Clofarabine Administered Daily for 5 Days in Adult Patients With Refractory Solid Tumors | Biotech Hunter | Biotech Hunter