NCT02000934

A Study of TAK-659 in Adult Participants With Advanced Solid Tumor and Lymphoma Malignancies

An Open-Label, Dose Escalation, Phase 1, First-in-Human Study of TAK-659 in Adult Patients With Advanced Solid Tumor and Lymphoma Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: Calithera Biosciences, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is an open-label, multicenter, phase 1, dose escalation study of TAK-659 in adult participants with advanced solid tumor and lymphoma malignancies. This study will be the first to administer TAK-659 to humans. The participants population during dose escalation (Part A) will consist of adults previously diagnosed with any form of a solid tumor or lymphoma for which standard, curative, or life-prolonging treatment does not exist or is no longer effective. This first-in-human (FIH) study will include 5 dose expansion cohorts in refractory and/or relapsed Chronic Lymphocytic Leukemia (CLL), Diffuse Large B Cell Lymphoma (DLBCL), indolent Non Hodgkin Lymphoma (iNHL), Mantle Cell Lymphoma (MCL), Post Transplant Lymphoproliferative Disorder (PTLD) (Part B) following completion of dose escalation (Part A).

Conditions

• Advanced Solid Tumor and Lymphoma Malignancies

Interventions

Type	Name	Description
DRUG	TAK-659	TAK-659 tablet

Timeline

• Start date: 2013-12-31
• Primary completion: 2021-06-29
• Completion: 2021-06-29
• First posted: 2013-12-04
• Last updated: 2023-02-08

Locations

15 sites across 4 countries: United States, Italy, Spain, United Kingdom