A Study to Evaluate the Effect of Food on the Pharmacokinetics (PK) of TAK-659 in Participants With Advanced Solid Tumor

February 6, 2023 updated by: Calithera Biosciences, Inc

An Open-Label, Phase 1, Two-Way, Crossover Study of the Effect of Food on the Pharmacokinetics of TAK-659 in Patients With Advanced Solid Tumor and/or Lymphoma Malignancies

The purpose of this study is to characterize the effect of food on the single-dose PK of TAK-659 in participants with advanced solid tumors and/or lymphomas.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The drug being tested in this study is called TAK-659. TAK-659 is being tested in participants with advanced solid tumors and/or lymphomas in order to determine the effect of food on the PK of single oral dose of TAK-659 tablet formulation. The study will enroll approximately 20 participants. Participants will be randomly and equally assigned (by chance, like flipping a coin) to 1 of the 2 treatment sequences following as:

  • TAK-659 100 mg Fasted + TAK-659 100 mg Fed
  • TAK-659 100 mg Fed + TAK-659 100 mg Fasted

All participants will be asked to take single oral dose of TAK-659 tablet on Day 1 and Day 8 of a 15-day food effect treatment period. Upon completion of the food effect treatment period, participants can continue in the optional post food effect treatment period to receive TAK-659 100 mg, once daily in a 28-day treatment cycle until disease progression, unacceptable toxicity, or the start of another anticancer therapy upon request by the investigator and agreement by the project clinician.

This single or multi-center trial will be conducted in the United States. The overall time to participate in this study is up to 58 weeks. Participants will visit the clinic on Day -1 and remain confined until Day 15 of food effect treatment period. Participants will make a visit to the clinic after 28 days after last dose of study drug for a follow-up assessment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Yale Cancer Center
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Barbara Ann Karmanos Cancer Institute
    • New York
      • Bronx, New York, United States, 10461
        • Montefiore Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Must have a histologically or cytologically confirmed metastatic and/or advanced solid tumor and/or lymphoma for which standard curative or life-prolonging treatment does not exist, or is no longer effective or tolerable.
  2. Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
  3. Has a life expectancy of at least 3 months.
  4. Suitable venous access for the study-required blood sampling (that is, PK).

  5. Must have adequate organ function, including the following:

    • Adequate bone marrow reserve: absolute neutrophil count (ANC) greater than or equal to (>=) 1000 per cubic millimeter (/mm^3), platelet count >=75,000/ mm^3 (>=50,000 per micro liter (/mcL) for participants with bone marrow involvement), and hemoglobin >=8 gram per deciliter (g/dL) (red blood cell [RBC] transfusion allowed >=14 days before assessment).
    • Hepatic: total bilirubin less than or equal to (<=) 1.5*the upper limit of the normal range (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=2.5*ULN.
    • Renal: serum creatinine <=1.5*ULN or creatinine clearance >=60 milliliter per minute (mL/min) as estimated by the Cockcroft-Gault equation or based on urine collection (12 or 24 hours).

Exclusion Criteria:

  1. Central nervous system (CNS) lymphoma; active brain or leptomeningeal metastases, as indicated by positive cytology from lumbar puncture or computed tomography (CT) scan/magnetic resonance imaging (MRI).
  2. History of drug-induced pneumonitis requiring treatment with steroids; history of idiopathic pulmonary fibrosis, organizing pneumonia, or evidence of active pneumonitis on screening chest CT scan; history of radiation pneumonitis in the radiation field (fibrosis) is permitted.
  3. Systemic anticancer treatment (including investigational agents) less than 3 weeks before the first dose of study treatment (<=4 weeks for antibody-based therapy including unconjugated antibody, antibody-drug conjugate, and bi-specific T-cell engager agent; <=8 weeks for cell-based therapy or anti-tumor vaccine).
  4. Radiotherapy less than 3 weeks before the first dose of study treatment.

  5. Use or consumption of any of the following substances:

    • Medications or supplements that are known to be inhibitors of P-glycoprotein (P-gp) and/or strong reversible inhibitors of cytochrome P450 (CYP) 3A within 5*the inhibitor half-life (if a reasonable half-life estimate is known), or within 7 days (if a reasonable half-life estimate is unknown), before the first dose of study drug.
    • Medications or supplements that are known to be strong CYP3A mechanism-based inhibitors or strong CYP3A inducers and/or P-gp inducers within 7 days or within 5 times the inhibitor or inducer half-life (whichever is longer) before the first dose of study drug. In general, the use of these agents is not permitted during the study except in cases in which an AE must be managed during interruption of study drug dosing.
    • Food or beverages containing grapefruit within 5 days before the first dose of study drug. Note that food and beverages containing grapefruit are not permitted during the study.
  6. Major surgery within 14 days before the first dose of study drug and not recovered fully from any complications from surgery.
  7. Active secondary malignancy that requires treatment. Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection and are considered disease-free at the time of study entry.
  8. Lactose-intolerance or are unwilling/unable to consume the protocol-specified standardized high-fat, high-calorie breakfast.
  9. Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of TAK-659, including difficulty swallowing tablets or diarrhea greater than (>) Grade 1 despite supportive therapy.
  10. Treatment with high-dose corticosteroids for anticancer purposes within 14 days before the first dose of TAK-659; daily dose equivalent to 10 mg oral prednisone or less is permitted. Corticosteroids for topical use or in nasal spray or inhalers are allowed.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: TAK-659 100 mg Fasted + TAK-659 100 mg Fed
TAK-659 100 milligram (mg), tablet, orally under fasted state, once on Day 1, followed by TAK-659 100 mg, tablet, orally under fed state, once on Day 8 of a 15-day food effect treatment period.
Drug: TAK-659
TAK-659 tablet.
EXPERIMENTAL: TAK-659 100 mg Fed + TAK-659 100 mg Fasted
TAK-659 100 mg, tablet, orally under fed state, once on Day 1, followed by TAK-659 100 mg, tablet, orally under fasted state, once on Day 8 of a 15-day food effect treatment period.
Drug: TAK-659
TAK-659 tablet.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Cmax: Maximum Observed Plasma Concentration for TAK-659
Time Frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-659
Time Frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-659
Time Frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Cmax: Maximum Observed Plasma Concentration for TAK-659
Time Frame: Day 8 pre-dose and at multiple time points (up to 168 hours) post-dose
Day 8 pre-dose and at multiple time points (up to 168 hours) post-dose
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-659
Time Frame: Day 8 pre-dose and at multiple time points (up to 168 hours) post-dose
Day 8 pre-dose and at multiple time points (up to 168 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-659
Time Frame: Day 8 pre-dose and at multiple time points (up to 168 hours) post-dose
Day 8 pre-dose and at multiple time points (up to 168 hours) post-dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs)
Time Frame: Baseline up to 28 days after the last dose of study drug (up to 58 weeks)
Baseline up to 28 days after the last dose of study drug (up to 58 weeks)
Percentage of Participants With Grade 3 or Above Adverse Event (AE)
Time Frame: Baseline up to 28 days after the last dose of study drug (up to 58 weeks)
AE Grades will be evaluated as per National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE), version 4.03. Grade 1 scaled as Mild; Grade 2 scaled as Moderate; Grade 3 scaled as severe or medically significant but not immediately life-threatening; Grade 4 scaled as life-threatening consequences; and Grade 5 scaled as death related to AE.
Baseline up to 28 days after the last dose of study drug (up to 58 weeks)
Percentage of Participants With Drug-related AEs
Time Frame: Baseline up to 28 days after the last dose of study drug (up to 58 weeks)
Baseline up to 28 days after the last dose of study drug (up to 58 weeks)
Percentage of Participants With Drug-related Grade 3 or Above AEs
Time Frame: Baseline up to 28 days after the last dose of study drug (up to 58 weeks)
AE Grades will be evaluated as per NCI CTCAE, version 4.03. Grade 1 scaled as Mild; Grade 2 scaled as Moderate; Grade 3 scaled as severe or medically significant but not immediately life-threatening; Grade 4 scaled as life-threatening consequences; and Grade 5 scaled as death related to AE.
Baseline up to 28 days after the last dose of study drug (up to 58 weeks)
Percentage of Participants who Experience at Least 1 Serious Adverse Event (SAE)
Time Frame: Baseline up to 28 days after the last dose of study drug (up to 58 weeks)
Baseline up to 28 days after the last dose of study drug (up to 58 weeks)
Percentage of Participants who Discontinue due to an AE
Time Frame: Baseline up to 28 days after the last dose of study drug (up to 58 weeks)
Baseline up to 28 days after the last dose of study drug (up to 58 weeks)
Percentage of Participants who Meet the Takeda Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose
Time Frame: Baseline up to 28 days after the last dose of study drug (up to 58 weeks)
Baseline up to 28 days after the last dose of study drug (up to 58 weeks)
Percentage of Participants who Meet the Takeda Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose
Time Frame: Baseline up to 28 days after the last dose of study drug (up to 58 weeks)
Baseline up to 28 days after the last dose of study drug (up to 58 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Calithera Biosciences, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 28, 2018

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 14, 2019

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 20, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 27, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 2, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C34009
  • U1111-1201-1081 (REGISTRY: WHO)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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