Prostate CancerPhase 2NCT00072670
A Phase 2 Study of Trabectedin (Yondelis) in Adult Male Participants With Advanced Prostate Cancer
A Phase 2 study testing Trabectedin in people with Prostate Cancer, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate safety and efficacy of trabectedin (ET-743) in adult male participants with advanced metastatic (spread of cancer cells from one part of the body to another) prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Trabectedin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Nov 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed adenocarcinoma of the prostate
- Radiographically documented metastatic disease
- Surgical or chemical castration
- Prostate-specific antigen greater than or equal to (>=) 5 nanogram per milliliter (ng/ml)
- Eastern Cooperative Oncology Group performance status of 0, 1, or 2
- Androgen Independent disease
Who cannot join
- 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 percent of bone marrow reserves must have been completed at least 4 weeks before study entry)
- Participant not employing adequate contraception
- Other serious illness or medical conditions as : Uncontrolled congestive heart failure or history of myocardial infection or active angina pectoris within six months preceding registration; active infectious process; chronic active liver disease, including chronic Hepatitis B, chronic Hepatitis C, or cirrhosis
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114-2617
About this study
Official title: Phase 2 Study of Yondelis in Men With Advanced Prostate Carcinoma
The purpose of this study is to evaluate safety and efficacy of trabectedin (ET-743) in adult male participants with advanced metastatic (spread of cancer cells from one part of the body to another) prostate cancer.
Read the detailed description
This is an open-label (all people know the identity of the intervention), non-randomized, multi-center and Phase 2 study in adult male participants with advanced metastatic prostate cancer. The study consists of 3 parts: Screening (consists of 14 days before study commences on Day -1); Treatment (consists of 4-week dosing cycles wherein trabectedin will be administered as intravenously at a dose of either 0.58 milligram per square meter [mg/m^2] weekly 3-hour infusion, or 1.5 mg/m^2 or 1.2 mg/m^2 every three weeks 24-hour infusion); and Follow-up (until survival after the first dose of trabectedin). Participants will discontinue study treatment at disease progression or unacceptable toxicity unless, in the Investigator's opinion, it is deemed that the participants will continue to derive benefit from trabectedin. Efficacy will be evaluated primarily through decline in prostate-specific antigen (substance in blood that is measured to check for prostate cancer) after 72 hours of therapy on Day 1. Participants' safety will be monitored throughout the study.
- Conditions
- Prostate Cancer
- Being tested
- Trabectedin
- Keywords
- Prostate cancer, Advanced prostate cancer, Metastatic prostate cancer, Trabectedin, Yondelis, ET-743
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrabectedinDrug
Also called ET-743, Yondelis
Trabectedin will be administered intravenously as either 0.58 milligram per square meter (mg/m^2) weekly as 3-hour infusion or 1.5 mg/m^2 or 1.2 mg/m^2 every three weeks as 24-hour infusion until disease progression or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Trabectedin 0.58 milligram per square meter (mg/m^2) | Experimental | Trabectedin will be administered as 3-hour intravenous infusion at dose of 0.58 mg/m^2 weekly on Day 1, 8 and 15 in 28-day cycle and will be continued until disease progression or unacceptable toxicity. Receives: Drug: Trabectedin |
| Trabectedin 1.5 mg/m^2 | Experimental | Trabectedin will be administered at dose of 1.5 mg/m^2 as 24-hour infusion every three weeks, and will be continued until disease progression or unacceptable toxicity. Receives: Drug: Trabectedin |
| Trabectedin 1.2 mg/m^2 | Experimental | Trabectedin will be administered at dose of 1.2 mg/m^2 as 24-hour infusion every three weeks, and will be continued until disease progression or unacceptable toxicity. Receives: Drug: Trabectedin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving Prostate-Specific Antigen (PSA) Response
The PSA response will be evaluated according to National Cancer Institute PSA Working Group criterion, which is, greater than or equal to 50 percent decrease in PSA from Baseline after the first dose of study drug, which would be subsequently confirmed by a measurement, that is, at least 4 or more weeks after initial documentation of PSA.
Measured: Day 1 of each cycle until first documented disease progression up to 4 years
Secondary outcomes (2)
Duration of Prostate-Specific Antigen Response
Duration of Prostate-Specific Antigen (PSA) response will be analyzed in all participants for whom a response will be observed. The Duration of a PSA response is the time from a PSA response to PSA progression.
Measured: Day 1 of each cycle until first documented disease progression up to 4 years
Time to disease progression
Time to disease progression is defined as the time period, from initiation of study treatment until documentation of disease progression. If participant will discontinue the study or lost to follow-up without progression or receive further anticancer therapy after study treatment discontinuation in absence of progression, time to progression will be censored at the time of the last PSA evaluation recorded.
Measured: Day 1 of each cycle until first documented disease progression up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2003 (estimated)
- Study startJan 2004
- Primary completionSep 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PharmaMar
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00072670
- Sponsor's protocol ID
- CR101850
- Other IDs
- ET-B-025-02
- Status last verified
- Apr 2014
- First submitted
- 7 Nov 2003
- Last updated
- 8 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Yondelis in Men With Advanced Prostate Carcinoma
- ClinicalTrials.gov ID
- NCT00072670
- Acronym / sponsor ID
- CR101850
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, Advanced prostate cancer, Metastatic prostate cancer, Trabectedin, Yondelis, ET-743
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Collaborators
- PharmaMar
- Study start
- Jan 2004
- Primary completion
- Sep 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 11 Nov 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate safety and efficacy of trabectedin (ET-743) in adult male participants with advanced metastatic (spread of cancer cells from one part of the body to another) prostate cancer.
Detailed description
This is an open-label (all people know the identity of the intervention), non-randomized, multi-center and Phase 2 study in adult male participants with advanced metastatic prostate cancer. The study consists of 3 parts: Screening (consists of 14 days before study commences on Day -1); Treatment (consists of 4-week dosing cycles wherein trabectedin will be administered as intravenously at a dose of either 0.58 milligram per square meter [mg/m^2] weekly 3-hour infusion, or 1.5 mg/m^2 or 1.2 mg/m^2 every three weeks 24-hour infusion); and Follow-up (until survival after the first dose of trabectedin). Participants will discontinue study treatment at disease progression or unacceptable toxicity unless, in the Investigator's opinion, it is deemed that the participants will continue to derive benefit from trabectedin. Efficacy will be evaluated primarily through decline in prostate-specific antigen (substance in blood that is measured to check for prostate cancer) after 72 hours of therapy on Day 1. Participants' safety will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Trabectedin 0.58 milligram per square meter (mg/m^2) | Experimental | Drug: TrabectedinTrabectedin will be administered as 3-hour intravenous infusion at dose of 0.58 mg/m^2 weekly on Day 1, 8 and 15 in 28-day cycle and will be continued until disease progression or unacceptable toxicity. |
| Trabectedin 1.5 mg/m^2 | Experimental | Drug: TrabectedinTrabectedin will be administered at dose of 1.5 mg/m^2 as 24-hour infusion every three weeks, and will be continued until disease progression or unacceptable toxicity. |
| Trabectedin 1.2 mg/m^2 | Experimental | Drug: TrabectedinTrabectedin will be administered at dose of 1.2 mg/m^2 as 24-hour infusion every three weeks, and will be continued until disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically confirmed adenocarcinoma of the prostate
- Radiographically documented metastatic disease
- Surgical or chemical castration
- Prostate-specific antigen greater than or equal to (>=) 5 nanogram per milliliter (ng/ml)
- Eastern Cooperative Oncology Group performance status of 0, 1, or 2
Key exclusion criteria (4 listed)
- 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 percent of bone marrow reserves must have been completed at least 4 weeks before study entry)
- Participant not employing adequate contraception
- Other serious illness or medical conditions as : Uncontrolled congestive heart failure or history of myocardial infection or active angina pectoris within six months preceding registration; active infectious process; chronic active liver disease, including chronic Hepatitis B, chronic Hepatitis C, or cirrhosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrabectedinAlso: ET-743, YondelisTrabectedin will be administered intravenously as either 0.58 milligram per square meter (mg/m^2) weekly as 3-hour infusion or 1.5 mg/m^2 or 1.2 mg/m^2 every three weeks as 24-hour infusion until disease progression or unacceptable toxicity. | Drug | Trabectedin 0.58 milligram per square meter (mg/m^2), Trabectedin 1.2 mg/m^2, Trabectedin 1.5 mg/m^2 |
Primary outcome
Percentage of Participants Achieving Prostate-Specific Antigen (PSA) Response
Time frame: Day 1 of each cycle until first documented disease progression up to 4 years
The PSA response will be evaluated according to National Cancer Institute PSA Working Group criterion, which is, greater than or equal to 50 percent decrease in PSA from Baseline after the first dose of study drug, which would be subsequently confirmed by a measurement, that is, at least 4 or more weeks after initial documentation of PSA.
2 secondary outcomes
Duration of Prostate-Specific Antigen Response
Time frame: Day 1 of each cycle until first documented disease progression up to 4 years
Time to disease progression
Time frame: Day 1 of each cycle until first documented disease progression up to 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2014.
- Phase 2 Study of Yondelis in Men With Advanced Prostate CarcinomaLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trabectedin in people with Prostate Cancer, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving Prostate-Specific Antigen (PSA) Response (time frame: Day 1 of each cycle until first documented disease progression up to 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2014.