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

This study has suspended participant recruitment.
Sponsor:
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00459823
First received: April 11, 2007
Last updated: March 23, 2009
Last verified: March 2009
  Purpose

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.


Condition Intervention Phase
Cancer
Drug: E7107
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Open-Label, Single-Arm, Dose Escalation Study of E7107 Administered IV (Bolus) on Days 1, 8, and 15 Every 28 Days to Patients With Solid Tumours

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • To determine MTD of E7107. Safety and tolerability. [ Time Frame: Every six weeks. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics of E7107. Evaluation of anti-tumor activity. To investigate potential biomarkers of pharmacodynamic effect. [ Time Frame: Every 21 days. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: May 2007
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: E7107
E7107 administered by intravenous infusion (as a 2-5 minutes bolus) on days 1, 8 and 15 every 28 days.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

Patients must meet all of the inclusion criteria outlined below in order to be eligible to participate in the study.

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00459823

Locations
Netherlands
Department of Medical Oncology, Erasmus University Medical Centre
Rotterdam, Netherlands
Spain
Medical Oncology Service. Vall d'Hebron University Hospital
Barcelona, Spain, 08035
Sponsors and Collaborators
Eisai Limited
Investigators
Study Director: Jantien Wanders, M.D. Eisai Limited
  More Information

No publications provided

Responsible Party: Eisai Limited Medical Information Services, Eisai Limited
ClinicalTrials.gov Identifier: NCT00459823     History of Changes
Other Study ID Numbers: E7107-E044-102
Study First Received: April 11, 2007
Last Updated: March 23, 2009
Health Authority: Spain: Spanish Agency of Medicines and Health Products (AEMPS)
The Netherlands: Centrale Commissie Mensgebonden Onderzoek (CCMO)

Keywords provided by Eisai Inc.:
Cancer
solid tumors

ClinicalTrials.gov processed this record on October 20, 2014