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

NCT03359733 | Withdrawn Phase 1 FDA Drug

• 2 other identifiers: C34009U1111-1201-1081
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Lymphoma, Malignant; Advanced Solid Neoplasms

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (6)

• Cmax: Maximum Observed Plasma Concentration for TAK-659

  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

  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

  Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose

• Cmax: Maximum Observed Plasma Concentration for TAK-659

  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

  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

  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)

  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)

  Baseline up to 28 days after the last dose of study drug (up to 58 weeks)

• Percentage of Participants With Drug-related AEs

  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

  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)

  Baseline up to 28 days after the last dose of study drug (up to 58 weeks)

Study Arms (2)

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.

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.

Drug: TAK-659

Interventions

TAK-659 DRUG

TAK-659 tablet.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Calithera Biosciences, Inc: lead

Study Sites (3)

Yale Cancer Center

New Haven, Connecticut, 06519, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Lymphoma

Interventions

TAK-659

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Medical Director

  Millennium Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: December 2, 2017
• Study Start: February 28, 2018
• Primary Completion: January 14, 2019
• Study Completion: August 20, 2019
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

US (3)