AzTrials
AzTrials

Gastric CancerPhase 1/2NCT00165594

A Study of E7070 in Patients With Gastric Cancer

A Phase 1/2 study testing E7070 in people with Gastric Cancer, run by Eisai Co., Ltd. at 5 sites in Japan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 20 to 74 years
Conditions the study is for
Gastric Cancer
What is being tested?
E7070
How many people
50 participants
Where
5 sitesJapan
Study dates
Feb 2005to Aug 2006
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
Show all 46Show fewer
  • 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
  • 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:
  • Chemotherapy, endocrinotherapy, immunotherapy, radiotherapy, surgical therapy, and other investigational products: 4 weeks
  • Nitrosourea agents and mitomycin C: 6 weeks
  • 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.
  • 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).
  • WBC 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 at the center
  • Alanine aminotransferase [ALT]: ≤2.5 times the upper limit of normal at the center
  • Total bilirubin: ≤1.5 times the upper limit of normal at the center
  • Serum creatinine: ≤1.5 times the upper limit of normal at the center
  • 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.
  • Chemotherapy, endocrinotherapy, immunotherapy, radiotherapy, surgical therapy, and other investigational products: ≥4 weeks
  • Nitrosourea agents and mitomycin C: ≥6 weeks
  • 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.

Who cannot join

  • 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).
Show all 59Show fewer
  • 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)
  • A history of serious arrhythmia including Torsades de pointes
  • Patients who require nutrition support using intravenous hyper alimentation (IVH) or enteral nutrition.
  • Patients who have a history of hypersensitivity to sulfonamide.
  • Premenopausal women who are 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 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 sub investigator.
  • Patients with systemic infectious disease.
  • Patients with severe peritoneal dissemination that meet any of the following items.
  • Clinical sign of ileus or sub ileus
  • Worse than moderate ascites (beyond over pelvic cavity)
  • 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:
  • 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)
  • 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)
  • A history of serious arrhythmia including Torsades de pointes
  • Patients who require nutrition support with intravenous hyper alimentation (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)
  • Premenopausal 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 sub investigator

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Japan5 sites

  • Study site

    Chuo-ku, Tokyo, 104-0045

  • Study site

    Kashiwa, Chiba, 277-0882

  • Study site

    Sagamihara-shi, Kanagawa

  • Study site

    Sunto-gun, Shizuoka, 411-0934

  • Study site

    Takatsuki-shi, Osaka

Other trials in Japan

About this study

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

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
Being tested
E7070
Keywords
gastric cancer, Phase I, Phase IIa, E7070, Indisulam, Pharmacogenomic, 2C19
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • E7070Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase I study:

  2. Dose-limiting toxicity (DLT)

  3. Phase IIa study:

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

Secondary outcomes (6)

  1. Phase I study:

  2. Plasma E7070 concentration.

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

  4. Anti-tumor effect based on (RECIST).

  5. Phase IIa study:

  6. Adverse drug reaction.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2005 (estimated)
  2. Study startFeb 2005
  3. Primary completionJul 2006
  4. Study completionAug 2006

Why it stopped: Study was completed.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00165594
Sponsor's protocol ID
E7070-J081-217
Status last verified
Jan 2014
First submitted
12 Sep 2005
Last updated
23 Jan 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing E7070 in people with Gastric Cancer, run by Eisai Co., Ltd. at 5 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 46 inclusion and 59 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Study was completed.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase I study:. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00165594.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in