Conditions: Relapsed or Refractory Peripheral T Cell Lymphoma
Allocation: NON_RANDOMIZED | Intervention model: SEQUENTIAL
Enrollment: 171
Healthy volunteers: no

Brief summary:
This is a multinational, non-randomized, open-label, Phase 1/2 clinical study to evaluate the safety, tolerability and anti-tumor efficacy of AZD4205 as monotherapy in patients with peripheral T cell lymphoma (PTCL), who have relapsed from or are refractory/intolerant to standard systemic treatment.

Phase 1 part:

Around 20\~40 patients will be subsequently enrolled into 2 different dose ascending cohorts. Additional 10\~20 patients may be enrolled to further explore a selected dose defined by dose escalation cohorts.

Phase 2 part:

After the recommended phase 2 dose (RP2D) is defined, a phase 2 single-arm open-label pivotal study will be conducted to assess anti-tumor efficacy and safety of AZD4205 at RP2D in patients with refractory or relapsed PTCL.

Detailed description:

Arms:
arm 1: Group A: Open label golidocitinib at dose A, once daily (Phase 1) arm 2: Group B: Open label golidocitinib at dose B, once daily (Phase 1) arm 3: Group C: Open label golidocitinib at a selected dose, once daily (Phase 1) arm 4: Group D: Open label golidocitinib at the RP2D, once daily (Phase 2)

Interventions: intervention 1: golidocitinib
Intervention descriptions: intervention 1: golidocitinib will be administered orally as capsules. golidocitinib treatment will be continued until disease progression or intolerant adverse reactions

Protocol document:
Prot_000.pdf: 

























































































































































































































































































SAP_001.pdf: