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Spots Global Cancer Trial Database for E7070 in Treating Patients With Solid Tumors

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Trial Identification

Brief Title: E7070 in Treating Patients With Solid Tumors

Official Title: Phase I Study to Determine the Safety of E7070 in Patients With a Solid Tumor on a Single IV Infusion Repeated Every 3 Weeks

Study ID: NCT00003976

Interventions

indisulam

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of E7070 in treating patients who have solid tumors.

Detailed Description: OBJECTIVES: I. Determine the maximum tolerated dose of E7070 in patients with solid tumors. II. Assess the qualitative and quantitative toxicity in terms of predictability, duration, intensity, onset, reversibility, and dose relationship of this treatment regimen in this patient population. III. Determine a safe dose for phase II evaluation. IV. Assess the pharmacokinetics of this treatment regimen in these patients. V. Determine any possible antitumor activity of this regimen in these patients. OUTLINE: This is a dose escalation study. Patients receive E7070 IV over 1 hour once every 3 weeks. Treatment continues for at least 2 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of E7070 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose limiting toxicity. PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study within 12 months.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Innsbruck Universitaetsklinik, Innsbruck, , Austria

Kaiser Franz Josef Hospital, Vienna, , Austria

Institut Jules Bordet, Brussels, , Belgium

Ludwig Institute for Cancer Research-Brussels Branch, Brussels, , Belgium

Universitair Ziekenhuis Antwerpen, Edegem, , Belgium

U.Z. Gasthuisberg, Leuven, , Belgium

Herlev Hospital - University Hospital of Copenhagen, Herlev, , 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

Universitaetsklinik und Strahlenklinik - Essen, Essen, , Germany

Klinikum Nurnberg, Nuremberg (Nurnberg), , Germany

Antoni van Leeuwenhoekhuis, Amsterdam, , Netherlands

Academisch Ziekenhuis der Vrije Universiteit, Amsterdam, , Netherlands

Academisch Ziekenhuis Groningen, Groningen, , Netherlands

University Medical Center Nijmegen, Nijmegen, , Netherlands

Rotterdam Cancer Institute, Rotterdam, , Netherlands

Norwegian Radium Hospital, Oslo, , Norway

University Hospital, Basel, , Switzerland

Inselspital, Bern, Bern, , Switzerland

Kantonsspital - Saint Gallen, Saint Gallen, , Switzerland

Newcastle General Hospital, Newcastle Upon Tyne, England, United Kingdom

Ninewells Hospital and Medical School, Dundee, Scotland, United Kingdom

Western General Hospital, Edinburgh, Scotland, United Kingdom

C.R.C. Beatson Laboratories, Glasgow, Scotland, United Kingdom

Contact Details

Name: Jean-Pierre Armand, MD

Affiliation: Gustave Roussy, Cancer Campus, Grand Paris

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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