Study to Assess the Safety and Tolerability of U3-1565 in Subjects With Advanced Solid Malignant Tumors

PHASE1CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

January 31, 2011

Primary Completion Date

January 31, 2013

Study Completion Date

January 31, 2013

Conditions
Advanced Solid Malignant TumorsAdvanced Ovarian Cancer
Interventions
DRUG

U3-1565

U3 1565 will be provided as a sterile, frozen solution. Each glass vial will contain 1.1 mL (1 mL extractable) of study medication with a concentration of 100 mg/mL. U3 1565 will be diluted in a final volume of 100 mL and administered by continuous IV infusion over 60 minutes. Infusion times can be extended to a maximum of 120 minutes for subjects unable to tolerate the 60 minute infusion.

Trial Locations (4)

19111

Fox Chase Cancer Center, Philadelphia

37203

Sarah Cannon Research Institute, Nashville

48201

Karmanos Cancer Center, Detroit

73104

Univ. Oklahoma Health Science Center, Oklahoma City

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Daiichi Sankyo

INDUSTRY

NCT01290471 - Study to Assess the Safety and Tolerability of U3-1565 in Subjects With Advanced Solid Malignant Tumors | Biotech Hunter | Biotech Hunter