A Phase 1 Study of SP-02L in Relapsed or Refractory Patients With Peripheral T-cell Lymphoma (PTCL)

PHASE1CompletedINTERVENTIONAL
Enrollment

17

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

April 30, 2015

Study Completion Date

July 31, 2015

Conditions
Peripheral T-cell Lymphoma
Interventions
DRUG

SP-02L (darinaparsin for injection)

Cohort 1: Darinaparsin 200 mg/m2 for 5 consecutive days every 28 days (5 days therapy, 23 days no therapy is one cycle). Subjects may start from Cycle 1 and continue to a maximum of 4 cycles of treatment.

DRUG

SP-02L (darinaparsin for injection)

Cohort 2: Darinaparsin 300 mg/m2 for 5 consecutive days every 28 days (5 days therapy, 23 days no therapy is one cycle). Subjects may start from Cycle 1 and continue to a maximum of 4 cycles of treatment.

DRUG

SP-02L (darinaparsin for injection)

Cohort 3: Darinaparsin 300 mg/m2 for 5 consecutive days every 21 days (5 days therapy, 16 days no therapy is one cycle). Subjects may start from Cycle 1 and continue to a maximum of 4 cycles of treatment.

Trial Locations (4)

Unknown

Nagoya

Fukuoka

Sendai

Tokyo

Sponsors
All Listed Sponsors
lead

Solasia Pharma K.K.

INDUSTRY