Prostate CancerPhase 1NCT00052000
A Trial of MLN2704 in Subjects With Metastatic Androgen Independent Prostate Cancer
A Phase 1 study testing MLN2704 (DM1 conjugated monoclonal antibody MLN591) in people with Prostate Cancer, run by Millennium Pharmaceuticals, Inc. at 2 sites in United States.
Trial summary
This is the first study of MLN2704 administered to humans. The purpose of the study is to determine the highest dose of MLN2704 that can be given safely to patients with prostate cancer, and to identify any side effects associated with taking the drug. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- MLN2704 (DM1 conjugated monoclonal antibody MLN591)
- How many people
- 29 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2002to not given
- Phase
- Phase 1
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Each subject must meet the following inclusion criteria to be eligible for enrollment in the study:
- Histologic diagnosis (recent or remote) of prostate adenocarcinoma
- Progressive prostate cancer on physical exam, imaging studies and/or rising PSA, as defined by the presence of one or more of the following:
- Progressive tumor lesions (changes in the size of lymph nodes or parenchymal masses on physical examination or X-ray and CT scan or MRI)
- Progressive bone metastasis (presence of new lesion(s) on a bone scan)
- Progressive PSA levels despite castrate levels of testosterone
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- Patients who have received an anti-androgen must have shown progression of disease off of the anti-androgen prior to enrollment
- Failed hormonal therapy (including anti-androgen withdrawal therapy, as appropriate)
- LHRH (Luteinizing Hormone-Releasing Hormone)analog therapy:
- If subject is being treated with LHRH analog therapy at the time of screening the therapy must be maintained for the duration of the trial.
- If subject discontinued LHRH therapy prior to screening, the therapy must be discontinued ≥10 weeks prior to enrollment for 1 month depot preparations, 24 weeks for 3 month depot preparations, and 32 weeks for 4 month depot preparations.
- Agree to use an effective method of barrier contraception. Effective method of barrier contraception includes a condom with spermicidal jelly, a diaphragm with spermicidal jelly, or abstinence.
Who cannot join
- Subjects meeting any of the following exclusion criteria are not to be enrolled in the study:
- Use of corticosteroids and/or adrenal hormone inhibitors within 4 weeks of enrollment
- Use of PC-SPES (herbal supplement) within 4 weeks of enrollment
- Prior cytotoxic chemotherapy and/or radiation therapy within 6 weeks of enrollment
- Use of anti-androgen therapy (e.g., flutamide, bicalutamide, nilutamide) within 6 weeks of enrollment
- Prior monoclonal antibody administration, including Prostacint®
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- Peripheral neuropathy of Grade 2 or greater intensity, as defined by the NCI Common Toxicity Criteria (NCI CTC)
- History of CNS metastasis, including epidural disease
- History of seizure disorder requiring active treatment and/or stroke
- History of HIV infection
- Platelet count ≤100,000/mm3
- Absolute neutrophil count (ANC) ≤1,500/mm3
- Hematocrit ≤30 percent
- Abnormal coagulation profile (PT, and/or INR, PTT)
- Creatinine clearance <60 mL/min or Serum creatinine >2.0 mg/dL
- AST or ALT >1.5 X ULN
- Bilirubin (total) >ULN
- Serum calcium ≥12.5 mg/dL
- Active serious infection not controlled by antibiotics
- Active angina pectoris or NY Heart Association Class III-IV heart disease
- Karnofsky Performance Status <60
- Life expectancy <6 months
- Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or hematological organ systems that might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Sidney Kimmel Comprehensive Cancer Center @ Johns Hopkins
Baltimore, Maryland, 21231
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
Official title: A Phase 1 Single Ascending Dose Trial of MLN2704 (DM1 Conjugated Monoclonal Antibody MLN591) in Subjects With Metastatic Androgen Independent Prostate Cancer
This is the first study of MLN2704 administered to humans. The purpose of the study is to determine the highest dose of MLN2704 that can be given safely to patients with prostate cancer, and to identify any side effects associated with taking the drug. This study will also evaluate how MLN2704 is taken up (absorbed), broken down (metabolized) and eliminated (excreted) by the body. This process is called pharmacokinetic analysis.
Read the detailed description
This is a Phase 1 open-label dose-escalating trial designed to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and pharmacokinetics of a single dose of MLN2704 in subjects with metastatic androgen-independent prostate cancer.
- Conditions
- Prostate Cancer
- Being tested
- MLN2704 (DM1 conjugated monoclonal antibody MLN591)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MLN2704 (DM1 conjugated monoclonal antibody MLN591)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2003 (estimated)
- Study startNov 2002
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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants
Sponsor and investigators
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00052000
- Sponsor's protocol ID
- M59102-042
- Status last verified
- Feb 2007
- First submitted
- 21 Jan 2003
- Last updated
- 1 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Single Ascending Dose Trial of MLN2704 (DM1 Conjugated Monoclonal Antibody MLN591) in Subjects With Metastatic Androgen Independent Prostate Cancer
- ClinicalTrials.gov ID
- NCT00052000
- Acronym / sponsor ID
- M59102-042
- Conditions
- Prostate Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants
- Lead sponsor
- Millennium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2002
- First posted
- 22 Jan 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.
This is the first study of MLN2704 administered to humans. The purpose of the study is to determine the highest dose of MLN2704 that can be given safely to patients with prostate cancer, and to identify any side effects associated with taking the drug. This study will also evaluate how MLN2704 is taken up (absorbed), broken down (metabolized) and eliminated (excreted) by the body. This process is called pharmacokinetic analysis.
Detailed description
This is a Phase 1 open-label dose-escalating trial designed to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and pharmacokinetics of a single dose of MLN2704 in subjects with metastatic androgen-independent prostate cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Each subject must meet the following inclusion criteria to be eligible for enrollment in the study:
- Histologic diagnosis (recent or remote) of prostate adenocarcinoma
- Progressive prostate cancer on physical exam, imaging studies and/or rising PSA, as defined by the presence of one or more of the following:
- Failed hormonal therapy (including anti-androgen withdrawal therapy, as appropriate)
- LHRH (Luteinizing Hormone-Releasing Hormone)analog therapy:
Key exclusion criteria (23 listed)
- Subjects meeting any of the following exclusion criteria are not to be enrolled in the study:
- Use of corticosteroids and/or adrenal hormone inhibitors within 4 weeks of enrollment
- Use of PC-SPES (herbal supplement) within 4 weeks of enrollment
- Prior cytotoxic chemotherapy and/or radiation therapy within 6 weeks of enrollment
- Use of anti-androgen therapy (e.g., flutamide, bicalutamide, nilutamide) within 6 weeks of enrollment
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 |
|---|---|---|
| MLN2704 (DM1 conjugated monoclonal antibody MLN591) | Drug | – |
Primary outcome
Not reported in the source record.
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 1 Mar 2007.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MLN2704 (DM1 conjugated monoclonal antibody MLN591) in people with Prostate Cancer, run by Millennium Pharmaceuticals, Inc. at 2 sites 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 12 inclusion and 23 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 1 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
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 1 Mar 2007.