First-in-Human Study of TAK-659 in Advanced Solid Tumor and Lymphoma
Research type
Research Study
Full title
An Open-Label, Dose Escalation, Phase 1, First-in-Human Study of TAK-659 in Adult Patients with Advanced Solid Tumor and Lymphoma Malignancies
IRAS ID
172756
Contact name
Rakesh Popat
Contact email
Sponsor organisation
Millennium Pharmaceuticals Inc
Eudract number
2013-002292-18
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 2 months, 15 days
Research summary
This study is an open-label, multicenter, phase 1, dose escalation study of TAK-659 in adult patients with advanced solid tumor and lymphoma malignancies. This study will be the first to administer TAK-659 to humans.
The patient population 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 a dose escalation (Part A) and 2 dose expansion cohorts in refractory and/or relapsed chronic lymphocytic leukemia (CLL) and diffuse large B-cell lymphoma (DLBCL) (Part B).
Part A is currently open to recruitment in the United States.
Part A, called dose escalation, wiht 6 does levels, will enroll approximately 30 subjects with various types of solid tumor, lymphoma, and Chronic Lymphocytic Leukemia (CLL) cancers.
Part B, called dose expansion, will enroll approximately 14 subjects with Chronic Lymphocytic Leukemia (CLL) and approximately 29 subjects with Diffuse Large B Cell Lymphoma (DLBCL). There will be 3 sites in the UK.Study participation consists of a screening visit (within 28 days of first dose of study drug), up to 12 months of treatment (unless it is determined that a patient would continue to benefit beyond this timeframe) and an End of study visit (28 days after last dose of study drug). Part A will determine the highest dose of TAK-659 that can be given to patients and tolerated safely. Once this dose has been determined in Part A, a dose will be recommended for patients enrolling in Part B. The study tablet will be given orally during periods that last 28 days called "cycles". Each 28-day treatment cycle is composed of 28 consecutive days of study treatment.
The following assessments will be performed: Physical exam, vital signs, electrocardiograph (ECG), blood and urine samples, eye exams, bone marrow biopsy and aspirate, Imaging (CT,PET, MRI scans) and possible tumour biopsy.
REC name
London - City & East Research Ethics Committee
REC reference
15/LO/0302
Date of REC Opinion
23 Apr 2015
REC opinion
Further Information Favourable Opinion