Advanced Solid NeoplasmsPhase 1NCT03338881
A Study to Assess Mass Balance, Pharmacokinetics (PK), and Metabolism of Orally Administered [14 C]-TAK-659 in Participants With Advanced Solid Tumor and/or Lymphoma Malignancies
A Phase 1 study testing [14C]-TAK-659 and TAK-659 in people with Advanced Solid Neoplasms and Lymphoma Neoplasms, run by Calithera Biosciences, Inc.
Trial summary
The purpose of this study is to assess the mass balance and to characterize the pharmacokinetics (PK) in plasma and urine, and of total radioactivity in plasma and whole blood following a single oral dose of [14C]-TAK-659 solution containing 60 to 80 micro curie (Ci) of total radioactivity in participants with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Neoplasms, Lymphoma Neoplasms
- What is being tested?
- [14C]-TAK-659 and TAK-659
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 10 May 2018to 1 May 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have histologically or cytologically confirmed metastatic and/or advanced solid tumors and/or lymphomas for which standard curative or life-prolonging treatment does not exist or is no longer effective or tolerable.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Life expectancy of at least 3 months.
- Suitable venous access for the study-required blood sampling (that is, PK).
- Recovered (that is, grade less than or equal to [<=] 1 toxicity) from the reversible effects of prior anticancer therapy (with the exception of alopecia and Grade 1 neuropathy).
- Must have adequate organ function, including the following:
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- Adequate bone marrow reserve: absolute neutrophil count (ANC) greater than or equal to (>=) 1000 per microliter (/mcL); platelet count >=75,000/mcL (>=50,000/mcL for participants with bone marrow involvement); and hemoglobin >=8 gram per deciliter (g/dL) (red blood cell [RBC] and platelet transfusion allowed >=14 days before assessment).
- Hepatic: total bilirubin <=1.5 times the upper limit of the normal range (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=2.5*ULN.
- Renal: creatinine clearance >=60 milliliter per minute (mL/min) either as estimated by the Cockcroft-Gault equation or based on urine collection
Who cannot join
- 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).
- Known human immunodeficiency virus (HIV) positivity or HIV-related malignancy.
- Systemic anticancer treatment (including investigational agents) or radiotherapy within 3 weeks before the first dose of study treatment <=5 times the half-life for large molecule agents or <=4 weeks with evidence of progressive disease if 5 times the half-life is greater than (>) 4 weeks.
- 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 times 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 drugs
- 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 drugs. In general, the use of these agents is not permitted during the study except when an AE must be managed during interruption of study drug dosing.
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- Food or beverages containing grapefruit within 5 days before the first dose of study drugs. Note that food and beverages containing grapefruit are not permitted during the study.
- Ongoing nausea or vomiting that is Grade 2 or worse in intensity.
- Systemic infection requiring intravenous (IV) antibiotic therapy or other serious infection within 14 days before the first dose of study drug.
- 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.
- Irregular defecation patterns and/or history of urinary and/or fecal incontinence.
About this study
Official title: A Phase 1 Study to Assess Mass Balance, Pharmacokinetics, and Metabolism of Orally Administered [14 C]-TAK-659 in Patients With Advanced Solid Tumor and/or Lymphoma Malignancies
The purpose of this study is to assess the mass balance and to characterize the pharmacokinetics (PK) in plasma and urine, and of total radioactivity in plasma and whole blood following a single oral dose of [14C]-TAK-659 solution containing 60 to 80 micro curie (Ci) of total radioactivity in participants with advanced solid tumors and/or lymphomas.
Read the detailed description
The drug being tested in this study is called TAK-659. TAK-659 is being tested to treat people who have advanced solid tumor and/or lymphoma malignancies. This study will look at the quantitative characterization of the mass balance, metabolic pathways, and rates and routes of excretion of TAK-659.
The study will enroll approximately 6 participants. The study will consist of 2 periods: absorption, distribution, metabolism, and excretion (ADME) study period and optional post-ADME study period. In ADME study period, participants will be assigned with [14C]-TAK-659 100 milligram (mg). After completion of ADME study period, participants may choose to continue in the optional post-ADME study period to receive TAK-659 100 mg.
This single center trial will be conducted in Netherlands. The overall time to participate in ADME study period will be 14 days and if participants choose the option to continue in the post-ADME study period, the maximum duration of participation will be 12 months, unless in the opinion of the investigator and sponsor the participant would derive benefit from continued treatment beyond 12 months. Participants will be followed up to 28 days after last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first.
- Conditions
- Advanced Solid Neoplasms, Lymphoma Neoplasms
- Being tested
- [14C]-TAK-659, TAK-659
- Keywords
- Drug therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]-TAK-659Drug
[14C]-TAK-659 solution.
TAK-659Drug
TAK-659 tablets.
| Study group | Role | What they receive |
|---|---|---|
| [14C]-TAK-659 100 mg | Experimental | [14C]-TAK-659 100 mg, solution, orally, once, in the fasted state on Day 1. Participant will have the option to continue treatment with TAK-659 100 mg, tablets, orally, once daily in a 28-day treatment cycle for up to 12 months or until disease progression or unacceptable toxicity, or the start of another anticancer therapy in post-ADME study period. Receives: Drug: [14C]-TAK-659; Drug: TAK-659 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax: Maximum Observed Plasma Concentration for TAK-659
Measured: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
Cmax: Maximum Observed Plasma and Whole Blood Radioactivity for [14C]-TAK-659
Measured: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-659
Measured: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
Tmax: Time to Reach the Maximum Plasma and Whole Blood Radioactivity for [14C]-TAK-659
Measured: Day 1 pre-dose and at multiple time points (up to 240 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
Measured: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
AUClast: Area Under the Plasma and Whole Blood Radioactivity-time Curve from Time 0 to the Time of the Last Quantifiable Radioactivity for [14C]-TAK-659
Measured: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
Ae urine,14C: Cumulative Amount of Radioactivity Excreted in Urine for [14C]-TAK-659
Measured: Baseline up to 14 days
Ae feces, 14C: Cumulative Amount of Radioactivity Excreted in Feces for [14C]-TAK-659
Measured: Baseline up to 14 days
Ae total: Total Cumulative Amount of Radioactivity Excreted in Urine and Feces for [14C]-TAK-659
Measured: Baseline up to 14 days
Ae urine: Cumulative Amount of TAK-659 Excreted in Urine
Measured: Baseline up to 14 days
Percentage of Dose Excreted in Urine for TAK-659
Measured: Baseline up to 14 days
Renal Clearance (CLR) of TAK-659
Measured: Baseline up to 14 days
Secondary outcomes (9)
Percentage of TAK-659 Metabolites in Plasma
Measured: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
Percentage of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Measured: Baseline up to 28 days after the last dose of study drug (Week 58)
Percentage of Participants with Grade 3 or Higher Adverse Events (AEs)
Measured: Baseline up to 28 days after the last dose of study drug (Week 58)
Percentage of Participants with Drug Related AEs
Measured: Baseline up to 28 days after the last dose of study drug (Week 58)
Percentage of Participants with Drug Related Grade 3 or Higher AEs
Measured: Baseline up to 28 days after the last dose of study drug (Week 58)
Percentage of Participants with AEs Leading to Discontinuation of TAK-659
Measured: Baseline up to 28 days after the last dose of study drug (Week 58)
Percentage of Participants who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose
Measured: Baseline up to 28 days after the last dose of study drug (Week 58)
Percentage of Participants who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose
Measured: Baseline up to 28 days after the last dose of study drug (Week 58)
Percentage of TAK-659 Metabolites in Urine and Feces
Measured: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study start10 May 2018 (estimated)
- Primary completion1 May 2019 (estimated)
- Study completion1 May 2019 (estimated)
Why it stopped: Business decision: no safety or efficacy concerns
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Calithera Biosciences, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Millennium Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03338881
- Sponsor's protocol ID
- C34010
- Other IDs
- U1111-1203-6940, 2017-003383-12, 2017
- Status last verified
- Feb 2023
- First submitted
- 8 Nov 2017
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Assess Mass Balance, Pharmacokinetics, and Metabolism of Orally Administered [14 C]-TAK-659 in Patients With Advanced Solid Tumor and/or Lymphoma Malignancies
- ClinicalTrials.gov ID
- NCT03338881
- Acronym / sponsor ID
- C34010
- Conditions
- Advanced Solid Neoplasms, Lymphoma Neoplasms
- Keywords
- Drug therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business decision: no safety or efficacy concerns
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Calithera Biosciences, IncIndustry (pharma, biotech, devices)
- Study start
- 10 May 2018 (estimated)
- Primary completion
- 1 May 2019 (estimated)
- Study completion
- 1 May 2019 (estimated)
- First posted
- 9 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the mass balance and to characterize the pharmacokinetics (PK) in plasma and urine, and of total radioactivity in plasma and whole blood following a single oral dose of [14C]-TAK-659 solution containing 60 to 80 micro curie (Ci) of total radioactivity in participants with advanced solid tumors and/or lymphomas.
Detailed description
The drug being tested in this study is called TAK-659. TAK-659 is being tested to treat people who have advanced solid tumor and/or lymphoma malignancies. This study will look at the quantitative characterization of the mass balance, metabolic pathways, and rates and routes of excretion of TAK-659.
The study will enroll approximately 6 participants. The study will consist of 2 periods: absorption, distribution, metabolism, and excretion (ADME) study period and optional post-ADME study period. In ADME study period, participants will be assigned with [14C]-TAK-659 100 milligram (mg). After completion of ADME study period, participants may choose to continue in the optional post-ADME study period to receive TAK-659 100 mg.
This single center trial will be conducted in Netherlands. The overall time to participate in ADME study period will be 14 days and if participants choose the option to continue in the post-ADME study period, the maximum duration of participation will be 12 months, unless in the opinion of the investigator and sponsor the participant would derive benefit from continued treatment beyond 12 months. Participants will be followed up to 28 days after last dose of study drug or until the start of subsequent antineoplastic therapy, whichever occurs first.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]-TAK-659 100 mg | Experimental | Drug: [14C]-TAK-659, Drug: TAK-659[14C]-TAK-659 100 mg, solution, orally, once, in the fasted state on Day 1. Participant will have the option to continue treatment with TAK-659 100 mg, tablets, orally, once daily in a 28-day treatment cycle for up to 12 months or until disease progression or unacceptable toxicity, or the start of another anticancer therapy in post-ADME study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Must have histologically or cytologically confirmed metastatic and/or advanced solid tumors and/or lymphomas for which standard curative or life-prolonging treatment does not exist or is no longer effective or tolerable.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Life expectancy of at least 3 months.
- Suitable venous access for the study-required blood sampling (that is, PK).
- Recovered (that is, grade less than or equal to [<=] 1 toxicity) from the reversible effects of prior anticancer therapy (with the exception of alopecia and Grade 1 neuropathy).
Key exclusion criteria (11 listed)
- 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).
- Known human immunodeficiency virus (HIV) positivity or HIV-related malignancy.
- Systemic anticancer treatment (including investigational agents) or radiotherapy within 3 weeks before the first dose of study treatment <=5 times the half-life for large molecule agents or <=4 weeks with evidence of progressive disease if 5 times the half-life is greater than (>) 4 weeks.
- Use or consumption of any of the following substances:
- Ongoing nausea or vomiting that is Grade 2 or worse in intensity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [14C]-TAK-659[14C]-TAK-659 solution. | Drug | [14C]-TAK-659 100 mg |
| TAK-659TAK-659 tablets. | Drug | [14C]-TAK-659 100 mg |
Primary outcome
Cmax: Maximum Observed Plasma Concentration for TAK-659
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
Cmax: Maximum Observed Plasma and Whole Blood Radioactivity for [14C]-TAK-659
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-659
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
Tmax: Time to Reach the Maximum Plasma and Whole Blood Radioactivity for [14C]-TAK-659
Time frame: Day 1 pre-dose and at multiple time points (up to 240 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 240 hours) post-dose
AUClast: Area Under the Plasma and Whole Blood Radioactivity-time Curve from Time 0 to the Time of the Last Quantifiable Radioactivity for [14C]-TAK-659
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
Ae urine,14C: Cumulative Amount of Radioactivity Excreted in Urine for [14C]-TAK-659
Time frame: Baseline up to 14 days
Ae feces, 14C: Cumulative Amount of Radioactivity Excreted in Feces for [14C]-TAK-659
Time frame: Baseline up to 14 days
Ae total: Total Cumulative Amount of Radioactivity Excreted in Urine and Feces for [14C]-TAK-659
Time frame: Baseline up to 14 days
Ae urine: Cumulative Amount of TAK-659 Excreted in Urine
Time frame: Baseline up to 14 days
Percentage of Dose Excreted in Urine for TAK-659
Time frame: Baseline up to 14 days
Renal Clearance (CLR) of TAK-659
Time frame: Baseline up to 14 days
9 secondary outcomes
Percentage of TAK-659 Metabolites in Plasma
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
Percentage of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Baseline up to 28 days after the last dose of study drug (Week 58)
Percentage of Participants with Grade 3 or Higher Adverse Events (AEs)
Time frame: Baseline up to 28 days after the last dose of study drug (Week 58)
Percentage of Participants with Drug Related AEs
Time frame: Baseline up to 28 days after the last dose of study drug (Week 58)
Percentage of Participants with Drug Related Grade 3 or Higher AEs
Time frame: Baseline up to 28 days after the last dose of study drug (Week 58)
Percentage of Participants with AEs Leading to Discontinuation of TAK-659
Time frame: Baseline up to 28 days after the last dose of study drug (Week 58)
Percentage of Participants who Meet the 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 (Week 58)
Percentage of Participants who Meet the 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 (Week 58)
Percentage of TAK-659 Metabolites in Urine and Feces
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Millennium Pharmaceuticals, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [14C]-TAK-659 and TAK-659 in people with Advanced Solid Neoplasms and Lymphoma Neoplasms, run by Calithera Biosciences, Inc.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax: Maximum Observed Plasma Concentration for TAK-659 (time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.