Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
30 participants
INTERVENTIONAL
1998-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
PURPOSE: Phase I trial to study the effectiveness of E7070 in treating patients who have solid tumors.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* Determine the maximum tolerated dose (MTD) of E7070 when administered to adult patients with solid tumors.
* Determine the qualitative and quantitative toxic effects of this drug and study the predictability, duration, intensity, onset, reversibility and dose relationship of the toxic effects in this patient population.
* Propose a safe dose for phase II study.
* Assess the pharmacokinetics of this drug at different dose levels in this patient population.
* Determine any possible antitumor activity of this drug in this patient population.
OUTLINE: This is a dose escalation study.
Patients receive E7070 IV over 1 hour on days 1, 8, 15, and 22. Treatment continues every 6 weeks for at least 2 courses in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating doses of E7070 is escalated until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.
Patients are followed every 3 weeks.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study over 12 months.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
TREATMENT
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
indisulam
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Histologically or cytologically confirmed solid tumor that is not amenable to standard therapy
* No brain involvement or leptomeningeal disease
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* WHO 0-2
Life expectancy:
* At least 3 months
Hematopoietic:
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 9 g/dL
Hepatic:
* Bilirubin less than 1.5 mg/dL
* Liver function tests no greater than 2.5 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present)
Renal:
* Creatinine no greater than 1.4 mg/dL OR
* Creatinine clearance at least 60 mL/min
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No active bacterial infections (e.g., abscess or fistulae)
* No other nonmalignant disease that precludes protocol therapy
* No history of alcoholism, drug addiction, or psychotic disorders that preclude participation
* No glaucoma
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 4 weeks since prior immunotherapy
Chemotherapy:
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
* No other concurrent antitumor drugs
Endocrine therapy:
* At least 4 weeks since prior anticancer hormonal therapy
Radiotherapy:
* At least 4 weeks since prior radiotherapy (6 weeks for extensive radiotherapy)
* No concurrent radiotherapy (except localized palliative radiotherapy)
Surgery:
* Not specified
Other:
* No concurrent sulfonylurea agent for diabetes or antiarrhythmic agents
* No other concurrent investigational drugs
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Axel R. Hanauske, MD, PhD, MBA
Role: STUDY_CHAIR
University Hospital, Gasthuisberg
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Innsbruck Universitaetsklinik
Innsbruck, , Austria
Kaiser Franz Josef Hospital
Vienna, , Austria
Institut Jules Bordet
Brussels, , Belgium
Ludwig Institute for Cancer Research
Brussels, , Belgium
Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
U.Z. Gasthuisberg
Leuven, , Belgium
Herlev Hospital - University Hospital of Copenhagen
Copenhagen, , Denmark
Centre Jean Perrin
Clermont-Ferrand, , France
Centre Leon Berard
Lyon, , France
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, , France
Institut Claudius Regaud
Toulouse, , France
Institut Gustave Roussy
Villejuif, , France
Universitaetsklinikum Essen
Essen, , Germany
Vrije Universiteit Medisch Centrum
Amsterdam, , Netherlands
Antoni van Leeuwenhoekhuis
Amsterdam, , Netherlands
Academisch Ziekenhuis Groningen
Groningen, , Netherlands
University Medical Center Nijmegen
Nijmegen, , Netherlands
Erasmus University Medical Center
Rotterdam, , Netherlands
Norwegian Radium Hospital
Oslo, , Norway
University Hospital
Basel, , Switzerland
Inselspital, Bern
Bern, , Switzerland
Kantonsspital - St. Gallen
Sankt Gallen, , Switzerland
Newcastle General Hospital
Newcastle upon Tyne, England, United Kingdom
Royal Marsden Hospital
Sutton, England, United Kingdom
Ninewells Hospital and Medical School
Dundee, Scotland, United Kingdom
Western General Hospital
Edinburgh, Scotland, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EORTC-16975
Identifier Type: -
Identifier Source: secondary_id
EISAI-E7070-E044-103
Identifier Type: -
Identifier Source: secondary_id
EORTC-16975
Identifier Type: -
Identifier Source: org_study_id