NeoplasmsPhase 1NCT00161642
Study Evaluating CMD-193 in Advanced Malignant Solid Tumors
A Phase 1 study testing CMD-193 in people with Neoplasms, run by Wyeth is now a wholly owned subsidiary of Pfizer at 3 sites in United States.
Trial summary
The purpose of this study is to determine the safety, tolerability and maximum tolerated dose of CMD-193. Preliminary information about how a person's body processes CMD-193 and how CMD-193 affects tumors will also be collected. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- CMD-193
- How many people
- 54 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2004to Jul 2007
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed malignant solid tumor that has progressed following standard therapy, or for which no standard effective treatment is available
- Tumor expression of Lewis Y antigen ( > or = 20% tumor cells positive for Lewis Y by immunohistochemistry assay)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Who cannot join
- Chemotherapy, radiation therapy, other cancer therapy, or investigational agents within 21 days of the first dose of CMD-193 (42 days if the previous chemotherapy included nitrosoureas or mitomycin C)
- Symptomatic or clinically active CNS metastases. Subjects who have had prior treatment with radiotherapy or surgical resection for CNS metastases will be permitted if CNS metastases have remained stable and have not required any treatment for at least 3 months prior to the first dose of CMD-193.
- Significant prior allergic reaction to recombinant human or murine proteins
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Study site
Lebanon, New Hampshire, 03756
Study site
Nashville, Tennessee, 37203
Study site
Philadelphia, Pennsylvania, 19111
About this study
Official title: A Phase 1 Dose Escalation Study of CMD-193 in Subjects With Advanced Malignant Tumors.
The purpose of this study is to determine the safety, tolerability and maximum tolerated dose of CMD-193. Preliminary information about how a person's body processes CMD-193 and how CMD-193 affects tumors will also be collected.
- Conditions
- Neoplasms
- Being tested
- CMD-193
- Keywords
- Malignant Tumors
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMD-193Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical examinations
hematology panels
ECG
Secondary outcomes (2)
Radiographic tumor evaluations
blood sampling for pharmacokinetic assessments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startNov 2004
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00161642
- Sponsor's protocol ID
- 3152K1-100
- Status last verified
- Sep 2009
- First submitted
- 7 Sep 2005
- Last updated
- 10 Sep 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose Escalation Study of CMD-193 in Subjects With Advanced Malignant Tumors.
- ClinicalTrials.gov ID
- NCT00161642
- Acronym / sponsor ID
- 3152K1-100
- Conditions
- Neoplasms
- Keywords
- Malignant Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 12 Sep 2005 (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 determine the safety, tolerability and maximum tolerated dose of CMD-193. Preliminary information about how a person's body processes CMD-193 and how CMD-193 affects tumors will also be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically confirmed malignant solid tumor that has progressed following standard therapy, or for which no standard effective treatment is available
- Tumor expression of Lewis Y antigen ( > or = 20% tumor cells positive for Lewis Y by immunohistochemistry assay)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Key exclusion criteria (3 listed)
- Chemotherapy, radiation therapy, other cancer therapy, or investigational agents within 21 days of the first dose of CMD-193 (42 days if the previous chemotherapy included nitrosoureas or mitomycin C)
- Symptomatic or clinically active CNS metastases. Subjects who have had prior treatment with radiotherapy or surgical resection for CNS metastases will be permitted if CNS metastases have remained stable and have not required any treatment for at least 3 months prior to the first dose of CMD-193.
- Significant prior allergic reaction to recombinant human or murine proteins
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 |
|---|---|---|
| CMD-193 | Drug | – |
Primary outcome
Physical examinations
hematology panels
ECG
2 secondary outcomes
Radiographic tumor evaluations
blood sampling for pharmacokinetic assessments
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 10 Sep 2009.
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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.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
3 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 CMD-193 in people with Neoplasms, run by Wyeth is now a wholly owned subsidiary of Pfizer at 3 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 3 inclusion and 3 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 10 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
What does the primary outcome measure?
Physical examinations. The study lists 3 primary outcomes in all. 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 10 Sep 2009.