A Study of CC-122 to Assess the Safety and Tolerability in Japanese Patients With Advanced Solid Tumors and Non-Hodgkin's Lymphoma (NHL)

Lymphoma, Non-Hodgkin Clinical Trial

Official title: A Phase 1, Multi-center, Open-label Dose-escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of CC-122 Administered Orally to Adult Japanese Subjects With Advanced Solid Tumors or Non-Hodgkin's Lymphoma

Status Completed

Clinical Trial Summary

To determine the safety and tolerability of CC-122 when administered orally to adult Japanese subjects with advanced solid tumors or Non-Hodgkin's Lymphoma (NHL) and to define the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).

Clinical Trial Description

This is a phase 1, multicenter, open-label, dose-escalation study that will evaluate the safety, tolerability, (Pharmacokinetics) PK, and preliminary efficacy of CC-122 in Japanese subjects with advanced solid tumors or Non-Hodgkin's Lymphoma (NHL).

Subjects will receive ascending dose levels of CC-122 from Cycle 1 onwards to measure PK and to determine safety and tolerability.

An initial cohort of at least three subjects will be given CC-122 at a dose of 2.0 mg on an intermittent dosing schedule (5 continuous days out of 7 days per week) and 3-6 subjects will be enrolled in subsequent dose levels. Dose escalation for subsequent cohorts will proceed according to a standard dose escalation design (3+3 design) (Storer, 1989) to establish initial toxicity. ;

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin

• NCT number: NCT02509039
• Study type: Interventional
• Source: Celgene
• Status: Completed
• Phase: Phase 1
• Start date: September 2, 2015
• Completion date: May 9, 2023