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TAK-264 (MLN0264) in Previously Treated Asian Patients with Advanced Gastrointestinal Carcinoma Expressing Guanylyl Cyclase C: Results from an Open-Label, Non-randomized Phase 1 Study / Journal of the Korean Cancer Association, 대한암학회지
Cancer Research and Treatment ; : 398-404, 2018.
Article in English | WPRIM | ID: wpr-713893
ABSTRACT

PURPOSE:

This phase 1 dose-escalation portion of the study evaluated the safety, pharmacokinetics (PK), and antitumor activity of TAK-264 in Asian patients with advanced gastrointestinal (GI) carcinoma or metastatic or recurrent gastric or gastroesophageal junction adenocarcinoma expressing guanylyl cyclase C (GCC). MATERIALS AND

METHODS:

Adult patients with advanced GI malignancies expressing GCC (H-score ≥ 10) received TAK-264 on day 1 of 3-week cycles as 30-minute intravenous infusions for up to 1 year or until disease progression or unacceptable toxicity. The primary objectives were to evaluate the safety profile including dose-limiting toxicities (DLTs) during cycle 1, determine the maximum tolerated dose (MTD), and characterize the PK profile of TAK-264.

RESULTS:

Twelve patients were enrolled and treated with 1.2 mg/kg (n=3), 1.5 mg/kg (n=3), or 1.8 mg/kg TAK-264 (n=6). Median number of treatment cycles received was two (range, 1 to 10). None of the patients experienced a DLT and the MTD was not determined. Ten patients (83%) experienced adverse events (AEs). The most common were neutropenia, anorexia, and nausea (each reported by four patients). Five patients (42%) experienced grade ≥ 3 AEs consisting of tumor hemorrhage and hypertension, ascites, adrenal insufficiency, neutropenia and asthenia. Serum exposure to TAK-264 increased proportionally with the dose and the median half-life was approximately 5.5-6.6 days. No patients experienced an objective response.

CONCLUSION:

TAK-264 demonstrated a manageable safety profile with limited antitumor activity consistent with studies conducted in Western patients with advanced GI malignancies. TAK-264 exposure increased proportionally with the dose.
Subject(s)

Full text: Available Index: WPRIM (Western Pacific) Main subject: Ascites / Asthenia / Stomach / Infusions, Intravenous / Pharmacokinetics / Adenocarcinoma / Anorexia / Adrenal Insufficiency / Disease Progression / Maximum Tolerated Dose Type of study: Controlled clinical trial Limits: Adult / Humans Language: English Journal: Cancer Research and Treatment Year: 2018 Type: Article

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Full text: Available Index: WPRIM (Western Pacific) Main subject: Ascites / Asthenia / Stomach / Infusions, Intravenous / Pharmacokinetics / Adenocarcinoma / Anorexia / Adrenal Insufficiency / Disease Progression / Maximum Tolerated Dose Type of study: Controlled clinical trial Limits: Adult / Humans Language: English Journal: Cancer Research and Treatment Year: 2018 Type: Article