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A Safety Study Utilizing Yondelis and Doxorubicin in Patients With a Type of Cancer Called Soft Tissue Sarcoma

NCT00102609 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2013-01-10

No results posted yet for this study

Summary

The purpose of the study is to determine the dose of the combination of trabectedin (Yondelis) and Doxorubicin for which neutropenia (low white blood cell counts) could be managed with filgrastim (a Granulocyte-Colony Stimulation Factor that is used to help control neutropenia) in patients with a type of cancer called soft tissue sarcoma.

Conditions

  • Soft Tissue Sarcoma
  • Sarcoma
  • Neoplasms, Connective and Soft Tissue
  • Neoplasms by Histologic Type
  • Neoplasms

Interventions

DRUG

Doxorubicin

Doxorubicin 50 to 75 mg/m2 administered intravenously on Day 1

DRUG

Trabectedin

Trabectedin 0.9 to 1.3 mg/m2 administered intravenously on Day 1 every 3 weeks for up to 6 cycles

DRUG

Dexamethasone

Dexamethasone 20 mg administered intravenously within 1 hour before the start of doxorubicin

Sponsors & Collaborators

  • PharmaMar

    collaborator INDUSTRY

  • PharmaMar S.A.U.

    collaborator UNKNOWN

  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    lead INDUSTRY

Principal Investigators

  • Johnson & Johnson Pharmaceutical Research and Development, LLC Clinical Trial · Johnson & Johnson Pharmaceutical Research and Development, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-30
Completion
2007-10-31

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00102609 on ClinicalTrials.gov