Georgia's Online Cancer Information Center

Find A Clinical Trial

A Multi-Center, Phase 2, Open-label, Parallel Cohort Study of Efficacy and Safety of Duvelisib in Patients With Relapsed or Refractory Peripheral T Cell Lymphoma (PTCL)

Status
Active
Cancer Type
Lymphoma
Trial Phase
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCD ID
NCT03372057
Protocol IDs
VS-0145-225 (primary)
NCI-2018-00275
Study Sponsor
Verastem Inc

Summary

This is a multi-center, parallel cohort, open-label, Phase 2 study of duvelisib, an oral dual inhibitor of PI3K-d,?, in patients with relapsed or refractory Peripheral T cell Lymphoma (PTCL).

Objectives

The study has 2 phases, a Dose Optimization Phase and an Expansion Phase. In the Dose Optimization Phase, patients will be randomly assigned to 1 of 2 study cohorts, as follows: - Cohort 1: Duvelisib PO BID at a starting dose of 25 mg, with potential escalation on a per-patient basis to 50 mg and then 75 mg, based on the patient's response to and tolerance of therapy, in 28-day cycles. - Cohort 2: Duvelisib 75 mg PO BID, administered in 28-day cycles . A total of 20 patients will be enrolled in the Dose Optimization Phase, with 10 patients per cohort. Based on the safety and activity data obtained in the Dose Optimization Phase of the study, the Expansion Phase dose of Duvelisib will be determined. In the Expansion Phase, approximately 90-100 patients may be enrolled and will receive Duvelisib dose in 28-day cycles as determined in Dose Optimization Phase.
Georgia CORE

 

Hearts and Minds Dedicated to Improving Cancer Care

Georgia CORE is a public-private partnership that creates collaboration among the state’s cancer organizations and institutions to connect more Georgians to quality, personalized cancer care. We welcome you to this one-of-a-kind online information center for all things related to cancer and survivorship care in Georgia.