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

Phase 1 Completed 17 enrolled Solasia Pharma K.K.

Non-randomizedSingle-groupOpen-labelTreatment

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).

Timeline

Start: 2011-09
Primary completion: 2015-04
Completion: 2015-07

Publications

Ogura M, Kim WS, Uchida T, Uike N, Suehiro Y, Ishizawa K, Nagai H, Nagahama F, Sonehara Y, Tobinai K. Phase I studies of darinaparsin in patients with relapsed or refractory peripheral T-cell lymphoma: a pooled analysis of two phase I studies conducted in Japan and Korea. Jpn J Clin Oncol. 2021 Feb 8;51(2):218-227. doi: 10.1093/jjco/hyaa177.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Darinaparsin	Small molecule	200 mg/m2	Intravenous
Subject	Darinaparsin	Small molecule	300 mg/m2	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications