CBT-1® in Combination With Doxorubicin in Patients With Metastatic, Unresectable Sarcomas Who Previously Progressed on Doxorubicin

PHASE1UnknownINTERVENTIONAL
Enrollment

46

Participants

Timeline

Start Date

March 29, 2018

Primary Completion Date

September 30, 2020

Study Completion Date

September 30, 2020

Conditions
Sarcoma
Interventions
DRUG

CBT-1®

"CBT-1®, oral, on days 1-7 of each cycle 21-day cycle. Participants will be assigned to dose level of CBT-1®:~Dose level 1 - 50 mg/m2/day Dose level 2 - 100 mg/m2/day Dose level 3 - 150 mg/m2/day Dose level 4 - 200 mg/m2/day Dose level 5 - 250 mg/m2/day Dose level 6 - 300 mg/m2/day doxorubicin, 37.5 mg/m2, IV, on days 5 and 6 of each cycle Study treatment discontinued after 450 mg/m2 lifetime cumulative dose of doxorubicin reached or after 4-5 cycles completed."

Trial Locations (6)

15232

RECRUITING

University of Pittsburgh Medical Center, Pittsburgh

32224

RECRUITING

Mayo Clinic, Jacksonville

90403

RECRUITING

Sarcoma Oncology Research Center, Santa Monica

98109

RECRUITING

Seattle Cancer Care Alliance, Seattle

02114

RECRUITING

Massachusetts General Hospital, Boston

02215

RECRUITING

Dana Farber Cancer Institute, Boston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

CBA Research

INDUSTRY

NCT03002805 - CBT-1® in Combination With Doxorubicin in Patients With Metastatic, Unresectable Sarcomas Who Previously Progressed on Doxorubicin | Biotech Hunter | Biotech Hunter