Safety and Pharmacokinetic Profiles of Two Formulations of CO-1.01 in Patients With Advanced Solid Tumors

PHASE1CompletedINTERVENTIONAL
Enrollment

17

Participants

Timeline

Start Date

April 30, 2011

Primary Completion Date

October 31, 2011

Study Completion Date

April 30, 2013

Conditions
Advanced Solid Tumor
Interventions
DRUG

CO-1.01 Formulation A (Aqueous suspension containing 15 mg/mL of drug solubilized in purified phospholipids)

1250 mg/m2 intravenous infusion on Day 1 for Treatment Sequence 1 and Day 8 for Treatment Sequence 2.

DRUG

CO-1.01 Formulation B (Aqueous suspension containing 30 mg/mL of drug solubilized in purified phospholipids)

1250 mg/m2 intravenous infusion on Day 1 for Treatment Sequence 2 and Day 8 for Treatment Sequence 1.

Trial Locations (3)

1066 CX

The Netherlands Cancer Institute, Amsterdam

6229 HX

Maastricht University Medical Center, Maastricht

3584 CX

University Medical Center Utrecht, Utrecht

Sponsors
All Listed Sponsors
lead

Clovis Oncology, Inc.

INDUSTRY

NCT01392976 - Safety and Pharmacokinetic Profiles of Two Formulations of CO-1.01 in Patients With Advanced Solid Tumors | Biotech Hunter | Biotech Hunter