A Dose Escalation Study of E7107 Administered IV (Bolus) on Days 1, 8, and 15 Every 28 Days to Patients With Solid Tumours

NCT ID: NCT00459823

Last Updated: 2009-03-24

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31

Brief Summary

Two-centre, open-label, non-randomized, dose-finding phase I study to determine the MTD of E7107 administered by intravenous infusion (as a 2-5 minutes bolus) on days 1, 8 and 15 every 28 days in patients with solid tumors, for whom therapy of proven efficacy does not exist or is not longer effective.

Conditions

Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

E7107

Intervention Type: DRUG

E7107 administered by intravenous infusion (as a 2-5 minutes bolus) on days 1, 8 and 15 every 28 days.

Interventions

E7107

E7107 administered by intravenous infusion (as a 2-5 minutes bolus) on days 1, 8 and 15 every 28 days.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients with histologically and/or cytologically confirmed solid tumours who have progressed after receiving approved therapies for their disease and for whom no curative therapies are available.

2. Surgery and radiotherapy must have been completed at least four weeks prior to study entry, and prior chemotherapy and other anti-cancer therapy, excluding bisphosphonates at a steady dose level, must have been discontinued for at least two weeks previously. All acute toxicities related to these treatments must have resolved.

3. Aged >= 18 years.

4. ECOG performance status score of 0 or 1.

5. Written informed consent prior to any study specific screening procedures, which will include voluntary additional consent to provide specimens specifically for pharmacogenomic analysis, with the understanding that the patient may withdraw consent at any time without prejudice.

6. Willing and able to comply with the protocol for the duration of the study.

7. Anticipated life expectancy > three months.

8. After MTD has been reached: patients must have measurable disease according to RECIST criteria.

Exclusion Criteria

Patients with the following characteristics will not be eligible for the study:

1. Symptomatic or progressive brain tumours or brain or leptomeningeal (CNS) metastases requiring clinical intervention, except if they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least two weeks before starting treatment with E7107.

2. Any of the following laboratory parameters:

1. haemoglobin < 9 g/dL (5.6 mM)

2. neutrophils <1.5 x 10^9/L

3. platelets <100 x 10^9/L

4. serum bilirubin >25 ìM (1.5 mg/dL)

5. liver function tests (defined as AST and ALT) with values >3 x ULN (5 x ULN if liver metastases are present)

6. serum creatinine > 105µM (or >1.5 mg/L) or creatinine clearance < 40 mL/min

3. Positive history of HIV, active hepatitis B or active hepatitis C or severe/uncontrolled intercurrent illness or infection.

4. Clinically significant cardiac impairment or unstable ischemic heart disease (greater than Class III according to NYHA classification) including a myocardial infarction within six months of study start.

5. Bleeding or thrombotic disorders, or using therapeutic dosages of anticoagulants.

6. History of alcoholism, drug addiction, or any psychiatric or psychological condition which, in the opinion of the Investigator, would impair study compliance.

7. Pregnancy or lactation (all women of childbearing potential must have a negative pregnancy test before inclusion in the study; peri-menopausal women must have been amenorrheic for at least 12 months, otherwise pregnancy test is required).

8. Fertile persons who are not willing to use adequate contraception (defined as two forms of contraception including a barrier method).

9. Patients with a marked screening or baseline prolongation of QT/QTc interval (i.e., repeated demonstration of a QTc interval > 450 msec); a history of additional factors of TdP (i.e., heart failure, hypokalaemia, family history of Long QT Syndrome).

10. Legal incapacity.

11. After MTD has been reached: Second malignancy within the past 5 years, except for carcinoma in situ of the cervix, basal cell carcinoma of the skin.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Eisai Limited

Principal Investigators

Jantien Wanders, M.D.

Role: STUDY_DIRECTOR

Eisai Limited

Locations

Department of Medical Oncology, Erasmus University Medical Centre

Rotterdam, , Netherlands

Medical Oncology Service. Vall d'Hebron University Hospital

Barcelona, , Spain

Countries

Netherlands; Spain

Other Identifiers

E7107-E044-102

Identifier Type: -

Identifier Source: org_study_id