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

NCT00459823 | Suspended Phase 1

• 1 other identifier: E7107-E044-102
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 2

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

Keywords

Cancer; solid tumors

Outcome Measures

Primary Outcomes (1)

• To determine MTD of E7107. Safety and tolerability.

  Every six weeks.

Secondary Outcomes (1)

• Pharmacokinetics of E7107. Evaluation of anti-tumor activity. To investigate potential biomarkers of pharmacodynamic effect.

  Every 21 days.

Study Arms (1)

1

EXPERIMENTAL

Drug: E7107

Interventions

E7107 DRUG

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

1

Eligibility Criteria

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

You may qualify if:

• 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.
• 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.
• Aged \>= 18 years.
• ECOG performance status score of 0 or 1.
• 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.
• Willing and able to comply with the protocol for the duration of the study.
• Anticipated life expectancy \> three months.
• After MTD has been reached: patients must have measurable disease according to RECIST criteria.

You may not qualify if:

• Patients with the following characteristics will not be eligible for the study:
• 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.
• Any of the following laboratory parameters:
• haemoglobin \< 9 g/dL (5.6 mM)
• neutrophils \<1.5 x 10\^9/L
• platelets \<100 x 10\^9/L
• serum bilirubin \>25 ìM (1.5 mg/dL)
• liver function tests (defined as AST and ALT) with values \>3 x ULN (5 x ULN if liver metastases are present)
• serum creatinine \> 105µM (or \>1.5 mg/L) or creatinine clearance \< 40 mL/min
• Positive history of HIV, active hepatitis B or active hepatitis C or severe/uncontrolled intercurrent illness or infection.
• 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.
• Bleeding or thrombotic disorders, or using therapeutic dosages of anticoagulants.
• History of alcoholism, drug addiction, or any psychiatric or psychological condition which, in the opinion of the Investigator, would impair study compliance.
• Fertile persons who are not willing to use adequate contraception (defined as two forms of contraception including a barrier method).
• 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).

Sponsors & Collaborators

• Eisai Limited: lead

Study Sites (2)

Department of Medical Oncology, Erasmus University Medical Centre

Rotterdam, Netherlands

Location

Medical Oncology Service. Vall d'Hebron University Hospital

Barcelona, 08035, Spain

Location

MeSH Terms

Conditions

Neoplasms

Interventions

E 7107

Study Officials

• Jantien Wanders, M.D.

  Eisai Limited

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: April 11, 2007
• First Posted: April 13, 2007
• Study Start: May 1, 2007
• Primary Completion: June 1, 2009
• Last Updated: March 24, 2009

Record last verified: 2009-03

Locations

ES (1); NL (1)