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



Status:Withdrawn
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:February 28, 2018
End Date:August 20, 2019

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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.

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.

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.
We found this trial at
3
sites
333 Cedar Street
New Haven, Connecticut 06520
(203) 785-4095
Yale Cancer Center Yale Cancer Center combines a tradition of innovative cancer treatment and quality...
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New Haven, CT
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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4100 John R
Detroit, Michigan 48201
800-527-6266
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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Detroit, MI
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