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Non-Randomized, Open, Uncontrolled, Dose Comparison Study of E7070 in Patients With Gastric Cancer


Phase 1/Phase 2
20 Years
74 Years
Not Enrolling
Both
Gastric Cancer

Thank you

Trial Information

Non-Randomized, Open, Uncontrolled, Dose Comparison Study of E7070 in Patients With Gastric Cancer

Inclusion Criteria


Inclusion Criteria (Phase I):

- 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).

1. WBCl count: ≥3,000/mm3, ≤12,000/mm3

2. Neutrophil count: ≥2,000/mm3

3. Platelet count: ≥100,000/mm3

4. Hemoglobin: ≥9.0 g/dL

5. Aspartate aminotransferase (AST): ≤2.5 times the upper limit of normal range at
the study site

6. Alanine aminotransferase (ALT): ≤2.5 times the upper limit of normal range at
the study site

7. Total bilirubin: ≤1.5 times the upper limit of normal rage at the study site

8. Serum creatinine: ≤1.5 times the upper limit of normal range at the study site

9. Partial pressure oxygen in arterial blood: ≥65 torr

- Patients who are EM/IM regarding CYP2C9 and CYP2C19

- Patients who consented to participate in this study with a written consent form

- Patients who have no carry-over adverse drug reaction(s) that affect the evaluation
of previous treatments and safety of E7070 after the completion of the previous
treatment. Required periods of wash-out from the end of previous treatment to the
beginning of the study treatment are as follows:

1. Chemotherapy, endocrinotherapy, immunotherapy, radiotherapy, surgical therapy,
and other investigational products: 4 weeks

2. Nitrosourea agents and mitomycin C: 6 weeks

3. Blood transfusion, blood preparations, and hematopoietic preparations including
G-CSF preparation: 2 weeks

- Patients who are expected to survive for at least 3 months from the beginning of the
study treatment.

Exclusion Criteria (Phase I):

- 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:

1. 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).

2. Myocardial infarction within 6 months.

3. Hepatic cirrhosis.

4. Interstitial pneumonia or pulmonary fibrosis.

5. Gastrointestinal fresh hemorrhage that requires repeated blood transfusion.

6. 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:

1. A history of prolonged QT/QTc intervals (male: QTc > 450 ms, female: QTc > 470
ms (Bazett's correction))

2. At the time of registration: QTc > 500 ms (Bazett's correction)

3. A history of serious arrhythmia including Torsades de pointes

- Patients who require nutrition support using intravenous hyperalimentation (IVH) or
enteral nutrition.

- Patients who have a history of hypersensitivity to sulfonamide.

- Premenoposal women who are currently pregnant, breastfeeding, or childbearing
potential. Premenoposal women of childbearing potential are defined as women with
less than a 12-month elapse after the last menstruation, and their pregnant test is
positive or not performed at the time of registration, or they do not consent for
using an appropriate contraceptive method.

- Male patients who have no intention of contraception.

- Patients on a coumarin agent or who has taken it within 2 weeks before starting the
study treatment.

- Patients who are currently taking an agent that is known to cause prolonged QT/QTc
intervals.

- Patients who are positive for a test of human immunodeficiency virus (HIV), hepatitis
C virus (HCV), or hepatitis B virus surface antigen (HBs antigen).

- Patients who have a history of drug or alcohol abuse.

- Patients who continuously require systemic treatment with a steroid during the study
period.

- Patients who are presently participating in another clinical study.

- Patients who are judged to be ineligible for participating in this study by the
investigator or subinvestigator.

Inclusion Criteria (Phase IIa):

- Patients who are histologically or cytologically proved efficacy for gastric cancer.

- Patients unable to undergo resection or with recurrence of cancer.

- Patients with evaluable lesions based on RECIST.

- Patients treated with 1 or 2 regimens of previous chemotherapy for gastric cancer (at
least 1 regimen using fluorouracil agent). Adjuvant chemotherapy with an oral
pyrimidine fluoride agent is not included in the number of previous regimen.

- Patients who are aged ≥20 years and <70 years.

- Patients graded as 0 - 2 as the Eastern Cooperative Oncology Group (ECOG) Performance
status (PS)

- Patients who can be hospitalized from the beginning of study treatment to the end of
the first cycle.

- Patients with well-maintained functions of major organs (bone marrow, liver, kidney,
and lung).

1. WBC count: ≥3,000/mm3, ≤12,000/mm3

2. Neutrophil count: ≥ 2,000/mm3

3. Platelet count: ≥100,000/mm3

4. Hemoglobin: ≥9.0 g/dL

5. Aspartate aminotransferase [AST]: ≤2.5 times the upper limit of normal at the
center

6. Alanine aminotransferase [ALT]: ≤2.5 times the upper limit of normal at the
center

7. Total bilirubin: ≤1.5 times the upper limit of normal at the center

8. Serum creatinine: ≤1.5 times the upper limit of normal at the center

9. Partial pressure oxygen in arterial blood: ≥65 torr

- Patients who are EM/IM regarding CYP2C9 and CYP2C19

- Patients who consented to participate in this study with a written consent form.

- Patients who have no carry-over adverse drug reaction(s) that affect the evaluation
of previous treatment and safety of E7070 after the completion of the previous
treatment. Required periods of wash-out from the end of previous treatment to the
beginning of study treatment are as follows.

1. Chemotherapy, endocrinotherapy, immunotherapy, radiotherapy, surgical therapy,
and other investigational products: ≥4 weeks

2. Nitrosourea agents and mitomycin C: ≥6 weeks

3. Blood transfusion, blood preparations, and hematopoietic preparations including
G-CSF preparation: ≥2 weeks

- Patients who are expected to survive for at least 3 months from the beginning of
treatment with the investigational product.

Exclusion Criteria (Phase IIa):

- Patients with systemic infectious disease.

- Patients with severe peritoneal dissemination that meet any of the following items.

1. Clinical sign of ileus or subileus

2. Worse than moderate ascites (beyond over pelvic cavity)

3. Clear peritoneal dissemination confirmed with enema

- Patients with a large volume of pleural effusion, ascites, or pericardial effusion
that require drainage.

- Patients who have brain metastasis with clinical symptoms

- Patients who have clinically significant metal disorder, attack, or central
nervous-related disorder.

- Patients who meet any of the following serious complications:

1. Ischemic heart disease or other heart disease including arrhythmia that require
medical treatment (excluding left ventricular hypertrophy, mild left ventricular
load, or mild right bundle branch block accompanied with hypertension)

2. Myocardial infarction within 6 months

3. Hepatic cirrhosis

4. Interstitial pneumonia or pulmonary fibrosis

5. Gastrointestinal fresh hemorrhage that requires repeated blood transfusion

6. 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.

1. A history of prolonged QT/QTc intervals (male: QTc > 450 ms, female: QTc > 470
ms (Bazett's correction))

2. At the time of registration: QTc > 500 ms (Bazett's correction)

3. A history of serious arrhythmia including Torsades de pointes

- Patients who require nutrition support with intravenous hyperalimentation (IVH) or
enteral nutrition.

- Patients who have a history of hypersensitivity to sulfonamide.

- Patients with active multiple malignant tumor (including disease-free interval within
5 years)

- Premenoposal women of currently pregnant, breastfeeding or childbearing potential.
Premenopausal women of childbearing potential are defined as women with less than a
12-month elapse after the last menstruation and pregnant test is positive or not
performed at the time of registration, or they do not consent for an appropriate
contraceptive method.

- Male patients who have no intention of doing contraception.

- Patients who are currently taking a coumarin agent or has taken it within 2 weeks
before the beginning of study treatment.

- Patients who are currently taking an agent that is known to cause prolonged QT/QTc
intervals.

- Patients who are positive for a test of human immunodeficiency virus (HIV), hepatitis
C virus (HCV), or hepatitis B virus surface antigen (HBs antigen).

- Patients who have a history of drug or alcohol abuse

- Patients who continuously require systemic treatment with a steroid during the study
period.

- Patients who are presently participating in another clinical study.

- Patients who are judged to be ineligible for participating in this clinical study by
the investigator or subinvestigator

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase I study:

Principal Investigator

Tatsuo Watanabe

Investigator Role:

Study Director

Investigator Affiliation:

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

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

E7070-J081-217

NCT ID:

NCT00165594

Start Date:

February 2005

Completion Date:

Related Keywords:

  • Gastric Cancer
  • gastric cancer
  • Phase I
  • Phase IIa
  • E7070
  • Indisulam
  • Pharmakogenomic
  • 2C19
  • Stomach Neoplasms

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