A Study to Provide Access to Trabectedin in Participants With Locally Advanced or Metastatic Soft Tissue Sarcoma Who Have Persistent or Recurrent Disease and Who Are Not Expected to Benefit From Currently Available Standard of Care Treatment

Sponsor

Janssen Research & Development, LLC (Industry)

Overall Status

No longer available

CT.gov ID

NCT00210665

Collaborator

(none)

Locations

Study Details

Study Description

Brief Summary

The purpose of this study is to facilitate access to trabectedin for eligible previously treated patients with soft tissue sarcoma (STS), who cannot be expected to benefit from currently available therapeutic options but who may benefit from treatment with trabectedin. The safety profile of trabectedin will be evaluated to further assess the potential risks of trabectedin treatment.

Condition or Disease	Intervention/Treatment	Phase
Sarcoma	Drug: Trabectedin

Detailed Description

This is a multicenter, open-label (all people know the identity of the intervention), single-arm study. It will consist of 2 Phases: a Screening Phase (up to 21 days before the first dose administration), and Treatment Phase (for patients meeting the continuation criteria). During the Treatment Phase, patients will receive a dose of 1.5 mg/m2 trabectedin intravenous formulation administered as a 24-hour infusion on Day 1 of each suggested 21-day treatment cycle. All patients will receive 20 mg dexamethasone (or corticosteroid equivalent to dexamethasone). Number of cycles is not specified for this study. Patients may continue to receive treatment as long as they obtain an overall clinical benefit, ie, until there is clear evidence of disease progression or unacceptable toxicity, as judged by the investigator. Trabectedin is the first of a new class of antitumor agents. Previous studies with trabectedin in patients who had been previously treated for soft tissue sarcoma have suggested that treatment with trabectedin resulted in tumor shrinkage, disease stabilization, and improved survival rates. However, hematologic toxicity, hepatic toxicity, and renal impairment were also observed in these patients. The safety profile of trabectedin will be evaluated to further assess the potential risks of trabectedin treatment in patients previously treated for soft tissue sarcoma who are not expected to benefit from currently available therapeutic options for treatment of soft tissue sarcoma. Safety will be monitored throughout the study.

Study Design

Study Type:

Expanded Access

Official Title:

A Multicenter, Open-Label, Single-Arm Study of YONDELIS (Trabectedin) for Subjects With Locally Advanced or Metastatic Soft Tissue Sarcoma Who Have Relapsed or Are Refractory to Standard of Care Treatment

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Unresectable advanced or metastatic histologically proven soft tissue sarcoma (STS). Eligibility will include adult participants with desmoplastic small round cell tumor
Must have relapsed or had progressive disease following standard of care treatment with chemotherapy prior to enrollment or intolerant to prior standard of care treatment with chemotherapy due to safety issues
Recovery from toxic effects of prior therapies to Grade 1 or better according to National Cancer Institute-Common Terminology Criteria of Adverse Events (criteria used to grade the severity of toxic effects on a scale from 0 to 5 - Grade 1 = mild in severity, Grade 0 = no severity)
Clinical test results within acceptable limits (ie, hematologic, clinical chemistry and hepatic function test results)
Female participants must be postmenopausal, surgically sterile, abstinent, or if sexually active, be practicing 2 effective methods of birth control (eg, prescription hormonal contraceptive, intrauterine device, double-barrier method [eg, condoms, occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam, cream, gel, film, or suppository]), before entry, and must agree to continue to use these same methods of contraception throughout the study and for 3 months thereafter. Male participants must agree to use an adequate contraception method as deemed appropriate by the investigator (eg, vasectomy, double-barrier, partner using effective contraception) and to not donate sperm for a minimum of 5 months after treatment discontinuation

Exclusion Criteria:

Diagnosis of Ewing's sarcoma or osteosarcoma, less than 3 weeks from last dose of radiation, systemic cytotoxic therapy (or 4 half lives, whichever is longer)
Active symptomatic viral hepatitis or chronic liver disease
Significant uncontrolled cardiac condition, including New York Heart Association Class II or greater heart failure, uncontrolled angina pectoris, myocardial infarction within 6 months before enrollment, significant pericardial disease, or uncontrolled or arrhythmias
Active infection
Female participant who is pregnant or breastfeeding

Contacts and Locations

Locations

	City	State	Country
1	Anchorage	Alaska	United States
2	San Diego	California	United States
3	Santa Monica	California	United States
4	Aurora	Colorado	United States
5	Daytona Beach	Florida	United States
6	Hollywood	Florida	United States
7	Atlanta	Georgia	United States
8	Coeur d'Alene	Idaho	United States
9	Park Ridge	Illinois	United States
10	Iowa City	Iowa	United States
11	Overland Park	Kansas	United States
12	Louisville	Kentucky	United States
13	Metairie	Louisiana	United States
14	Baltimore	Maryland	United States
15	Boston	Massachusetts	United States
16	Ann Arbor	Michigan	United States
17	Detroit	Michigan	United States
18	Rochester	Minnesota	United States
19	Saint Joseph	Missouri	United States
20	Omaha	Nebraska	United States
21	Newark	New Jersey	United States
22	New York	New York	United States
23	Cleveland	Ohio	United States
24	Tulsa	Oklahoma	United States
25	Portland	Oregon	United States
26	Philadelphia	Pennsylvania	United States
27	Charleston	South Carolina	United States
28	Houston	Texas	United States
29	San Antonio	Texas	United States
30	Seattle	Washington	United States
31	Milwaukee	Wisconsin	United States
32	Calgary	Alberta	Canada
33	Edmonton	Alberta	Canada
34	Toronto	Ontario	Canada
35	Edmonton N/A		Canada
36	Tel Aviv		Israel