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CompletedNCT00147212Updated Jan 18, 2013Results posted

ET 743 (Yondelis) in Men With Advanced Prostate Cancer

A Phase 2 interventional study of ET 743 in Prostate Cancer, sponsored by Massachusetts General Hospital. Completed at 2 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-01-18.

Sponsored by Massachusetts General Hospital · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
Male
01

Study summary

The main purpose of this study is to find out what effects (good or bad) trabectedin (ET743) has on men with advanced prostate carcinoma.

Read the detailed description
  • Treatment with trabectedin will be given once a week for three consecutive weeks with one week of no treatment. This four week period constitutes one cycle.
  • Trabectedin is given as an infusion through a central venous catheter and is administered over 3 hours.
  • On day 1 of each cycle a history, physical exam and blood tests will be performed and trabectedin will be administered.
  • On day 8 and day 15 of each cycle blood work will be performed and trabectedin will be administered.
  • Patients will continue to receive trabectedin as long as there is no disease progression or unacceptable side effects.
  • Scans (CT, MRI or bone) or x-rays may be done while the patient is on the trial at the discretion of the physician.
02

Conditions studied

  • Prostate Cancer

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Keywords

  • Advanced Prostate Cancer
  • Prostate Cancer
  • Trabectedin
  • ET 743
  • Yondelis
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 50 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • Histologically confirmed adenocarcinoma of the prostate
  • Radiographically documented metastatic disease
  • Surgical or chemical castration
  • Prostate specific antigen (PSA) > 5 ng/ml
  • Castration resistant prostate cancer (CRPC)
  • One previous taxane-based chemotherapy regimen
  • Eastern Cooperative Group (ECOG) performance status 0,1 or 2
  • Neutrophil count > 1,500/ul
  • Platelet count > 100,000/ul
  • Serum bilirubin \< 1.0 x upper limit normal (ULN)
  • Serum alkaline phosphatase \< 1.5 x ULN
  • Asparate aminotransferase/Alanine aminotransferase \< 2.5 x ULN
  • Albumin > 2.5 g/dl
  • Serum creatinine \< 1.5 x ULN
  • Prior hormonal therapy

Exclusion criteria

Exclusion Criteria:

  • Chemotherapy treatment within 4 weeks of study entry
  • Patient not employing adequate contraception
  • Serious illness or medical conditions, specifically: uncontrolled congestive heart failure or history of myocardial infection or active angina pectoris within 6 months; active infectious process; chronic active liver disease, including chronic hepatitis B, C or cirrhosis
  • Current anti-cancer treatment with any non-FDA approved investigational drug
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    1

    ET-743

    Drug: ET 743

Interventions

  • DrugET 743

    ET-743 administered IV by 24-hr infusion every 3 weeks

    Also known as: Trabectedin, Yondelis

06

What researchers measure

Primary outcomes

  1. The Number of Men With Advanced Prostate Cancer Treated With Trabectedin Who Have a PSA Response

    Prostate specific antigen (PSA) response rate, as defined by the PSA Working Group Criteria (see Bubley et al, J Clin Oncol. 1999 Nov;17(11):3461-7)

    Time frame: Participants were followed until disease progression, an average of 6 months

07

Results

Posted Jan 18, 2013

Participant flow

Completed

Participant flow — Overall Study
MilestoneTrabectedin
Started50
Completed50
Not completed0

Outcome measures

PrimaryThe Number of Men With Advanced Prostate Cancer Treated With Trabectedin Who Have a PSA Response

Prostate specific antigen (PSA) response rate, as defined by the PSA Working Group Criteria (see Bubley et al, J Clin Oncol. 1999 Nov;17(11):3461-7)

Time frame:
Participants were followed until disease progression, an average of 6 months
Reported as:
Number · participants
The Number of Men With Advanced Prostate Cancer Treated With Trabectedin Who Have a PSA Response
participantsTrabectedin
The Number of Men With Advanced Prostate Cancer Treated With Trabectedin Who Have a PSA Response7 (0 to 50)

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Trabectedin—10/50 (20%)0/50 (0%)
Most frequent serious events
Most frequent serious events
EventTrabectedin
NeutropeniaBlood and lymphatic system disorders10/50

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Trabectedin
<=18 years0
Between 18 and 65 years25
>=65 years25
Age Continuous
Age Continuous(years)Trabectedin
Mean65 ± 5
Sex: Female, Male
Sex: Female, Male(Participants)Trabectedin
Female0
Male50
Region of Enrollment
Region of Enrollment(participants)Trabectedin
Spain4
United States46
08

Study locations

2 sites
  • Masachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • Dana-Farber Cancer Institute
    Boston, Massachusetts 02115, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 18, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00147212
Lead sponsor
Massachusetts General Hospital
Collaborators
Dana-Farber Cancer Institute, PharmaMar
Responsible party
Dror Michaelson, MD (Assistant Professor of Medicine, Massachusetts General Hospital) — Principal investigator
First posted
Sep 7, 2005
Start date
Jun 2002
Primary completion
Apr 2008
Completion
Apr 2008
Results posted
Jan 18, 2013
Last update
Jan 18, 2013

Study contacts

Dror Michaelson, MD
principal investigator · Massachusetts General Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.

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