Tesetaxel as Second-line Therapy for Patients With Advanced Gastric Cancer

PHASE2UnknownINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

March 31, 2010

Primary Completion Date

September 30, 2012

Study Completion Date

October 31, 2012

Conditions
Adenocarcinoma of the StomachAdenocarcinoma of Esophagogastric Junction
Interventions
DRUG

Tesetaxel

"For subjects in Cohort A, a flat dose of 40 mg will be administered in Cycle 1; the dose will be adjusted based on body weight. In subsequent cycles, depending on tolerability, the Cycle 1 flat dose may be increased by 5 mg in Cycle 2, and the Cycle 2 flat dose may again be increased by 5 mg in Cycle 3.~For subjects in Cohort B, a flat dose of 50 mg will be administered in Cycle 1; the dose will be adjusted based on body weight. In subsequent cycles, depending on tolerability, the dose may be increased by 10 mg in Cycle 2.~For subjects in Cohort C, a dose of 27 mg/m2 will be administered in Cycle 1. In subsequent cycles, depending on tolerability, the dose will be increased to 35 mg/m2 in Cycle 2."

Trial Locations (4)

19104

Abramson Cancer of the University of Pennsylvania at Perelman Center for Advanced Medicine, Philadelphia

60611

Northwestern Medical Faculty Foundation, Chicago

77030

The University of Texax MD Anderson Cancer Center, Houston

120-752

Severance Hospital, Yonsei University Health System, Seoul

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Genta Incorporated

INDUSTRY