Lymphoma, MalignantPhase 1NCT03359733
A Study to Evaluate the Effect of Food on the Pharmacokinetics (PK) of TAK-659 in Participants With Advanced Solid Tumor
A Phase 1 study testing TAK-659 in people with Lymphoma, Malignant and Advanced Solid Neoplasms, run by Calithera Biosciences, Inc at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Malignant, Advanced Solid Neoplasms
- What is being tested?
- 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
- 3 sitesUnited States
- Study dates
- 28 Feb 2018to 20 Aug 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 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.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Has a life expectancy of at least 3 months.
- Suitable venous access for the study-required blood sampling (that is, PK).
- 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).
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).
- 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.
- 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).
- Radiotherapy less than 3 weeks before the first dose of study treatment.
- 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.
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- 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.
- Major surgery within 14 days before the first dose of study drug and not recovered fully from any complications from surgery.
- 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.
- Lactose-intolerance or are unwilling/unable to consume the protocol-specified standardized high-fat, high-calorie breakfast.
- 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.
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
Yale Cancer Center
New Haven, Connecticut, 06519
Montefiore Medical Center
The Bronx, New York, 10461
About this study
Official title: 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.
Read the 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.
- Conditions
- Lymphoma, Malignant, Advanced Solid Neoplasms
- Being tested
- TAK-659
- Keywords
- Drug therapy
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-659Drug
TAK-659 tablet.
| Study group | Role | What they receive |
|---|---|---|
| TAK-659 100 mg Fasted + TAK-659 100 mg Fed | Experimental | 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. Receives: Drug: TAK-659 |
| TAK-659 100 mg Fed + TAK-659 100 mg Fasted | Experimental | 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. Receives: 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 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
Measured: 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
Measured: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Cmax: Maximum Observed Plasma Concentration for TAK-659
Measured: 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
Measured: 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
Measured: Day 8 pre-dose and at multiple time points (up to 168 hours) post-dose
Secondary outcomes (8)
Percentage of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs)
Measured: 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)
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.
Measured: Baseline up to 28 days after the last dose of study drug (up to 58 weeks)
Percentage of Participants With Drug-related AEs
Measured: 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
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.
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline up to 28 days after the last dose of study drug (up to 58 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2017
- Study start28 Feb 2018 (estimated)
- Primary completion14 Jan 2019 (estimated)
- Study completion20 Aug 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 Lymphoma, MalignantStudies 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
- Randomised
- Intervention model
- Crossover
- 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
- NCT03359733
- Sponsor's protocol ID
- C34009
- Other IDs
- U1111-1201-1081
- Status last verified
- Feb 2023
- First submitted
- 27 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
- 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
- ClinicalTrials.gov ID
- NCT03359733
- Acronym / sponsor ID
- C34009
- Conditions
- Lymphoma, Malignant, Advanced Solid 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
- 28 Feb 2018 (estimated)
- Primary completion
- 14 Jan 2019 (estimated)
- Study completion
- 20 Aug 2019 (estimated)
- First posted
- 2 Dec 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 characterize the effect of food on the single-dose PK of TAK-659 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 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAK-659 100 mg Fasted + TAK-659 100 mg Fed | Experimental | Drug: TAK-659TAK-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. |
| TAK-659 100 mg Fed + TAK-659 100 mg Fasted | Experimental | Drug: TAK-659TAK-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Has a life expectancy of at least 3 months.
- Suitable venous access for the study-required blood sampling (that is, PK).
- Must have adequate organ function, including the following:
Key exclusion criteria (13 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).
- 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.
- 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).
- Radiotherapy less than 3 weeks before the first dose of study treatment.
- Use or consumption of any of the following substances:
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 |
|---|---|---|
| TAK-659TAK-659 tablet. | Drug | TAK-659 100 mg Fasted + TAK-659 100 mg Fed, TAK-659 100 mg Fed + TAK-659 100 mg Fasted |
Primary outcome
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
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
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
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
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
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
8 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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)
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TAK-659 in people with Lymphoma, Malignant and Advanced Solid Neoplasms, run by Calithera Biosciences, Inc at 3 sites in United States.
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 8 inclusion and 13 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.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 168 hours) post-dose). The study lists 6 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.