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NCT02000934 · ClinicalTrials.gov registry record · Phase 1
A Study of TAK-659 in Adult Participants With Advanced Solid Tumor and Lymphoma Malignancies
A Phase 1 study of Advanced Solid Tumor and Lymphoma Malignancies, sponsored by Calithera Biosciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 143
- Enrollment target
- 15
- Study locations
NCT02000934: Completed Phase 1 study of Advanced Solid Tumor and Lymphoma Malignancies, sponsored by Calithera Biosciences.
NCT02000934 is a Phase 1 study of Advanced Solid Tumor and Lymphoma Malignancies that has completed, run by Calithera Biosciences. The registered enrollment target is 143 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (138% higher). The trial reports 15 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02000934, a Phase 1 study of Advanced Solid Tumor and Lymphoma Malignancies, has completed, sponsored by Calithera Biosciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 143 participants
- Enrollment target
- 15
- Study locations
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).
Primary Outcome
DLT was defined as one of the following adverse events considered by the investigator to be possibly related to study drug: Grade 4 neutropenia unresolved to ≤Grade 1 or baseline \>7 days in absence of growth factor support;≥Grade 3 neutropenia with fever and/or infection; Grade 4 thrombocytopenia unresolved to ≤ Grade 1 or baseline \>7 days or a platelet count \<10,000/mm\^3; ≥Grade 3 thrombocytopenia with clinically significant bleeding; Grade 4 anemia; ≥Grade 3 nonhematological toxicity excep
Conditions Studied
Interventions
- DRUG TAK-659
Study Locations (15)
Other
- Azienda Ospedaliera Papa Giovanni XXIII - Bergamo
- Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi - Bologna
- Ospedale San Raffaele U.O. di Ematologia e Trapianto di midollo osseo - Milan
- Azienda Ospedaliera Universitaria Policlinico Tor Vergata - Roma
- Hospital Universitari Vall d'Hebron - Barcelona
- Avda. Reyes Catolicos, 2 - Madrid
- Centro Integral Oncologico Clara Campal - Madrid
Texas
- The Methodist Hospital Research Institute - Houston
- University of Texas Health Science Center at San Antonio - San Antonio
Florida
- Florida Cancer Specialists, Sarasota FL - Sarasota
Illinois
- Northwestern University - Chicago
Tennessee
- SCRI - Nashville
Greater London
- University College London Hospitals - London
Greater Manchester
- The Christie - Manchester
Surrey
- Royal Marsden Hospital - Sutton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 143 participants |
| Start Date | 2013-12-31 |
| Est. Completion | 2021-06-29 |
| Phase | Phase 1 |
What the finished NCT02000934 record still lists
NCT02000934 is an interventional study that assigns participants to a tested intervention. The registered 143 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (138% higher).
The record links to 1 condition, with Advanced Solid Tumor and Lymphoma Malignancies appearing as the primary indexed condition, and to 1 intervention - of which TAK-659 is the first listed.
NCT02000934 lists 15 locations in 8 states (Other, Texas, Florida).
Frequently Asked Questions
What is clinical trial NCT02000934 about?
NCT02000934 is a clinical study titled "A Study of TAK-659 in Adult Participants With Advanced Solid Tumor and Lymphoma Malignancies". 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 adu...
What is the current status of trial NCT02000934?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 143 participants. The study started on 2013-12-31. Estimated completion is 2021-06-29.
What conditions does trial NCT02000934 study?
This clinical trial studies the following conditions: Advanced Solid Tumor and Lymphoma Malignancies.
What interventions are being tested in trial NCT02000934?
The interventions under investigation include: TAK-659 (DRUG).
Who is sponsoring clinical trial NCT02000934?
This trial is sponsored by Calithera Biosciences, which has 22 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02000934 being conducted?
This trial has 15 study locations across Florida, Illinois, Tennessee, Texas, Greater London. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02000934's enrollment target sits among peer trials
143 401st of 2000 higher than 1,600 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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