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

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborators: PharmaMar; PharmaMar S.A.U.
• Treatments: Antineoplastic Agents; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Doxorubicin; Liposomal doxorubicin; Trabectedin

Criteria

Inclusion Criteria:

• Have a diagnosis of soft tissue sarcoma, recurrent or persistent

• Signed informed consent obtained for all patients before performing any study-related procedures

Exclusion Criteria:

• Patients treated with more than 1 prior chemotherapy regimen (including adjuvant (or other additional) therapy)

• Previous exposure to anthracyclines (a class of drugs used in cancer chemotherapy, example is Doxorubicin) or trabectedin

• Less than 4 weeks since radiation therapy

• Known metastases (spread) of cancer to the central nervous system

• Other ongoing serious illness present at the time of enrollment as determined by the Investigator