An Efficacy and Safety Study of Trabectedin Versus Doxorubicin-Based Chemotherapy in Participants With Translocation-Related Sarcomas (TRS)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00796120
• Date of registration: 20/11/2008
• Prospective Registration: No
• Primary sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Public title: An Efficacy and Safety Study of Trabectedin Versus Doxorubicin-Based Chemotherapy in Participants With Translocation-Related Sarcomas (TRS)
• Scientific title: A Randomized, Multicenter, Phase III Trial of Trabectedin (Yondelis) Versus Doxorubicin-based Chemotherapy as First-Line Therapy in Patients With Translocation-Related Sarcomas (TRS)
• Date of first enrolment: November 2008
• Target sample size: 121
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00796120
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

France, Germany, Spain, United Kingdom, United States

Contacts

• Name: Johnson & Johnson Pharmaceutical Research & Development, LLC Clinical Trial
• Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Key inclusion & exclusion criteria

Inclusion Criteria:

- Pathological diagnosis of translocation-related sarcomas (TRS) including the following
subtypes: alveolar soft part sarcoma, angiomatoid fibrous histiocytoma, clear cell
sarcoma, desmoplastic small round cell tumor, low grade endometrial stromal sarcoma
(prior hormone therapy allowed), low grade fibromyxoid sarcoma, myxoid chondrosarcoma,
myxoid/round cell liposarcoma (MRCL) and synovial sarcoma

- Participants must have unresectable locally advanced or metastatic progressive disease
prior to enrolment

- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2

- Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) within
normal limits according to institutional standards, as shown by echocardiography or
scintigraphy multiple-gated acquisition scan [MUGA]

- Measurable disease as defined by the radiological (computed tomography [CT] scan and
magnetic resonance imaging [MRI]) Response Evaluation Criteria in Solid Tumors (RECIST
v.1.0) guidelines

Exclusion Criteria:

- Known hypersensitivity to any components of the intravenous formulation of trabectedin
or the comparators

- Prior chemotherapy treatment or irradiation of the lesion if only one target lesion is
available

- Brain metastases and/or leptomeningeal metastases, even if treated

- Pregnant or lactating women or men and women of reproductive potential who are not
using effective contraceptive methods

- History of another neoplastic disease (except basal cell carcinoma or cervical
carcinoma in situ adequately treated) unless in remission for five years or more



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Sarcoma

Intervention(s)

Drug: Trabectedin

Drug: Ifosfamide

Drug: Doxorubicin

Primary Outcome(s)

Progression - Free Survival (PFS) [Time Frame: Every 6 weeks from randomization during the first 9 months and thereafter, every 9 weeks up to 20 months]

Secondary Outcome(s)

Overall Survival [Time Frame: Baseline up to End of Study (an average of 4 years)]

6-month Progression - Free Survival [Time Frame: 6 months]

Percentage of Participants With Objective Response [Time Frame: Every 6 weeks during first 9 months of the study and thereafter every 9 weeks up to 20 months]

Duration of Response (DOR) [Time Frame: Up to 20 months]

Secondary ID(s)

CR015769

ET-C-002-07

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

PharmaMar

Results

• Results available: Yes
• Date Posted: 16/09/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00796120