Status:
COMPLETED
A Phase 1 Study of SP-02L in Relapsed or Refractory Patients With Peripheral T-cell Lymphoma (PTCL)
Lead Sponsor:
Solasia Pharma K.K.
Conditions:
Peripheral T-cell Lymphoma
Eligibility:
All Genders
20+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of SP-02L monotherapy in Japanese patients with relapsed or refractory Peripheral T-cell Lymphoma (PTCL).
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Japanese patients aged ≥ 20 years of age at the day of obtaining the informed consent
- Patients with histologically confirmed diagnosis of the following:
- Peripheral T-cell Lymphoma, not otherwise specified (PTCL-NOS)
- Anaplastic Large Cell Lymphoma (ALCL ALK-positive/negative)
- Angioimmunoblastic T-cell Lymphoma (AITL)
- Have relapsed or refractory to at least one prior systemic chemotherapy for the above disease (currently requiring therapy)
- Have at least 1 evaluable lesion
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Life expectancy of at least 3 months
Exclusion
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01435863
Start Date
September 1 2011
End Date
July 1 2015
Last Update
August 13 2015
Active Locations (4)
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1
Nagoya, Aichi-ken, Japan
2
Fukuoka, Fukuoka, Japan
3
Sendai, Miyagi, Japan
4
Tokyo, Japan