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

NCT02000934 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2023-02-08

No results posted yet for this study

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

DRUG

TAK-659

TAK-659 tablet

Sponsors & Collaborators

  • Calithera Biosciences, Inc

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Millennium Pharmaceuticals, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2021-06-29
Completion
2021-06-29

Countries

  • United States
  • Italy
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02000934 on ClinicalTrials.gov