A Study of E7070 in Patients With Gastric Cancer

NCT00165594 | Terminated Phase 1

• 1 other identifier: E7070-J081-217
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 5

Brief Summary

Phase I study: To investigate primary objective (maximal tolerated dose and dose-limiting toxicity) and secondary objectives (pharmacokinetics, safety, estimation of a recommended dose, and anti-tumor effect by evaluable case) of E7070 in patients with gastric cancer who are extensive or intermediate metabolizer type (EM/IM) to CYP2C9 and CYP2C9 by intravenously administering once every 3 weeks. Phase IIa study: To investigate primary objective (response rate for efficacy assessment) and secondary objectives (frequency and severity of adverse drug reactions, and pharmacokinetics) of E7070 in patient with gastric cancer who are EM/IM type by intravenously administering once every 3 weeks.

Conditions

Gastric Cancer

Keywords

gastric cancer; Phase I; Phase IIa; E7070; Indisulam; Pharmacogenomic; 2C19

Outcome Measures

Primary Outcomes (4)

• Phase I study:

• Dose-limiting toxicity (DLT)

• Phase IIa study:

• Response rate based on Response Evaluation Criteria in Solid Tumors (RECIST)

Secondary Outcomes (6)

• Phase I study:

• Plasma E7070 concentration.

• Adverse event, adverse drug reaction, laboratory parameter, and vital sign.

• Anti-tumor effect based on (RECIST).

• Phase IIa study:

Interventions

E7070 DRUG

Eligibility Criteria

• Age: 20 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are histologically or cytologically confirmed to have gastric cancer.
• Patients who are non-responder to existing treatments with proved efficacy for gastric cancer, but any further effect is no longer expected with existing treatments.
• Patients who are aged ≥20 years and \<75 years at the time of registration.
• Patients graded as 0 - 2 of the Eastern Cooperative Oncology Group (ECOG) Performance status (PS)
• Patients who can be hospitalized between the beginning of the study treatment and the end of the first cycle.
• Patients with well-maintained functions of major organs (bone marrow, liver, kidney, and lung).
• WBCl count: ≥3,000/mm3, ≤12,000/mm3
• Neutrophil count: ≥2,000/mm3
• Platelet count: ≥100,000/mm3
• Hemoglobin: ≥9.0 g/dL
• Aspartate aminotransferase (AST): ≤2.5 times the upper limit of normal range at the study site
• Alanine aminotransferase (ALT): ≤2.5 times the upper limit of normal range at the study site
• Total bilirubin: ≤1.5 times the upper limit of normal rage at the study site
• Serum creatinine: ≤1.5 times the upper limit of normal range at the study site
• Partial pressure oxygen in arterial blood: ≥65 torr

You may not qualify if:

• Patients with systemic infectious disease.
• Patients with a large volume of pleural effusion, ascites, or pericardial effusion that requires drainage.
• Patients who have brain metastasis with clinical symptoms.
• Patients who have a clinically significant mental disorder, attack, or central nervous-related disorder.
• Patients who meet any of the following serious complications:
• Ischemic heart disorders or heart diseases including arrhythmia that requires medical treatment (excluding left ventricular hypertrophy, mild left ventricular load, or mild right bundle branch block accompanied with hypertension).
• Myocardial infarction within 6 months.
• Hepatic cirrhosis.
• Interstitial pneumonia or pulmonary fibrosis.
• Gastrointestinal fresh hemorrhage that requires repeated blood transfusion.
• Uncontrolled diabetes mellitus (hemoglobin Alc (HBAlc): ≥8.0 %)
• Patients whose NYHA classification is II - IV.
• Patients who meet any of the following items regarding prolonged QT/QTc intervals:
• A history of prolonged QT/QTc intervals (male: QTc \> 450 ms, female: QTc \> 470 ms (Bazett's correction))
• At the time of registration: QTc \> 500 ms (Bazett's correction)

Sponsors & Collaborators

• Eisai Co., Ltd.: lead

Study Sites (5)

Unknown Facility

Kashiwa, Chiba, 277-0882, Japan

Location

Unknown Facility

Sagamihara-shi, Kanagawa, Japan

Location

Unknown Facility

Takatsuki-shi, Osaka, Japan

Location

Unknown Facility

Sunto-gun, Shizuoka, 411-0934, Japan

Location

Unknown Facility

Chuo-ku, Tokyo, 104-0045, Japan

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

N-(3-chloro-7-indolyl)-1,4-benzenedisulphonamide

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Tatsuo Watanabe

  Eisai Co., Ltd - Development Clinical Research Department. Clinical Research Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 14, 2005
• Study Start: February 1, 2005
• Primary Completion: July 1, 2006
• Study Completion: August 1, 2006
• Last Updated: January 23, 2014

Record last verified: 2014-01

Locations

JP (5)