Phase II Study of Three Hour, Weekly Infusion of ET-743 (Yondelis) in Men With Advanced Prostate Carcinoma


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Neoplasm

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Trial Information

Phase II Study of Three Hour, Weekly Infusion of ET-743 (Yondelis) in Men With Advanced Prostate Carcinoma


This is an open-label (identity of assigned study drug will be known), 2-stage study of
ET-743 (trabectedin) in adult men with advanced metastatic prostate cancer. In the first
stage of the study, patients will be treated with weekly study drug infusions for 3 out of 4
weeks. If patients meet protocol-defined criteria for the primary endpoint of
prostate-specific antigen (PSA) response, the second stage will be initiated to also include
enrollment of patients previously treated with docetaxel. Disease response and safety will
be monitored.


Inclusion Criteria:



- Histologically confirmed adenocarcinoma of the prostate

- Radiographically documented metastatic disease

- Surgical or chemical castration

- Prostate-specific antigen >=5 ng/ml

- Androgen-independent disease

- Eastern Cooperative Oncology Group performance status of 0, 1, or 2

- Protocol-defined adequate bone marrow reserve, hepatic and renal function

- Protocol-defined adequate hepatic function

- Agrees to protocol-defined use of effective contraception

Exclusion Criteria:

- Treatment with chemotherapy or radiation therapy that was terminated at least 4 weeks
before study entry

- Treatment with extensive external beam radiation therapy or radionuclide therapy
within 6 weeks of study entry (palliative radiation involving less than 20% of bone
marrow reserves must have been completed at least 4 weeks before study entry)

- Other protocol-defined serious illnesses or medical conditions

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Prostate-specific antigen response

Outcome Time Frame:

Up to Month 12

Safety Issue:

No

Principal Investigator

Johnson & Johnson Pharmaceutical Research & Development Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

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

Authority:

United States: Food and Drug Administration

Study ID:

CR101850

NCT ID:

NCT00072670

Start Date:

January 2004

Completion Date:

September 2008

Related Keywords:

  • Prostate Neoplasm
  • Prostate neoplasm
  • Prostate cancer
  • Advanced prostate cancer
  • Metastatic prostate cancer
  • ET-743
  • Yondelis
  • Trabectedin
  • Neoplasms
  • Prostatic Neoplasms

Name

Location
Massachusetts General Hospital Boston, Massachusetts  02114-2617