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COMPLETED Phase 1

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

NCT02000934 · View on ClinicalTrials.gov ↗

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).

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

FieldValue
Enrollment Target 143 participants
Start Date 2013-12-31
Est. Completion 2021-06-29
Phase Phase 1

Sponsor

Calithera Biosciences

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02000934

The ClinicalTrials.gov registry entry for NCT02000934 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 143 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Calithera Biosciences, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02000934 reports 15 study locations spanning 8 distinct geographic areas — top geographies include Other, Texas, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02000934?

The interventions under investigation include: TAK-659 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02000934?

This trial is sponsored by Calithera Biosciences, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial