TumorsPhase 1NCT00105170
Safety and Tolerability of hCBE-11 in Subjects With Advanced Solid Tumors
A Phase 1 study testing hCBE-11 in people with Tumors, run by Biogen at 3 sites in United States.
Trial summary
This is a Phase I, open-label, dose-escalation study on subjects with advanced solid tumors. This is the first study of hCBE-11 in humans and is designed to determine the safety and how well patients tolerate this investigational drug. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumors
- What is being tested?
- hCBE-11
- How many people
- 13 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2005to Aug 2006
- 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
- Relapsed or refractory solid tumors not curable with standard therapy.
- At least one measurable lesion
- ECOG Performance Status less than or equal to 2
- Acceptable hematologic status
- Albumin greater than or equal to 2.5 g/dL
- Normal calculated glomerular filtration rate (GFR)
- Acceptable liver function
Who cannot join
- Uncontrolled cardiac disease, angina, congestive heart failure, or myocardial infarction within 6 months prior to Study Day
- Known history of hepatitis B or C, or HIV infection
- Clinically significant effusions, including pericardial, pleural, and ascites
- Serious non-malignant disease
- Central nervous system (CNS) metastatic involvement except where the disease has been successfully treated
- Investigational therapies within 4 weeks of Study Day 1
Show all 10Show fewer
- Radiation therapy of tumors to be followed for this study
- Chemotherapy, biologic therapy, or major surgery other than diagnostic within 4 weeks prior to Study Day 1
- Current Grade 3 or 4 neurological toxicity
- Concurrent anti-neoplastic therapy and/or steroids
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Research Site
Aurora, Colorado, 80045
Research Site
Philadelphia, Pennsylvania, 19111-2497
Research Site
Tucson, Arizona, 85724-5024
About this study
Official title: A Phase I, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Safety and Tolerability of hCBE-11, a Humanized Monoclonal Antibody, in Subjects With Advanced Solid Tumors
This is a Phase I, open-label, dose-escalation study on subjects with advanced solid tumors. This is the first study of hCBE-11 in humans and is designed to determine the safety and how well patients tolerate this investigational drug. The study duration is two years with treatment visits occurring weekly for either 4 or 8 weeks, follow-up for 8 weeks and long-term follow-up contact every 3 months thereafter.
- Conditions
- Tumors
- Being tested
- hCBE-11
- Keywords
- Monoclonal antibody, Advanced solid tumors, Tumors, hCBE-11
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hCBE-11Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of hCBE-11 in advanced solid tumors
Measured: up to 2 years
Secondary outcomes (1)
To define the recommended Phase II dose of hCBE-11
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2005 (estimated)
- Study startJan 2005
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumorsStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00105170
- Sponsor's protocol ID
- 202-01
- Status last verified
- Apr 2013
- First submitted
- 8 Mar 2005
- Last updated
- 26 Apr 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Safety and Tolerability of hCBE-11, a Humanized Monoclonal Antibody, in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00105170
- Acronym / sponsor ID
- 202-01
- Conditions
- Tumors
- Keywords
- Monoclonal antibody, Advanced solid tumors, Tumors, hCBE-11
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 13 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 9 Mar 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.
This is a Phase I, open-label, dose-escalation study on subjects with advanced solid tumors. This is the first study of hCBE-11 in humans and is designed to determine the safety and how well patients tolerate this investigational drug. The study duration is two years with treatment visits occurring weekly for either 4 or 8 weeks, follow-up for 8 weeks and long-term follow-up contact every 3 months thereafter.
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 (7 listed)
- Relapsed or refractory solid tumors not curable with standard therapy.
- At least one measurable lesion
- ECOG Performance Status less than or equal to 2
- Acceptable hematologic status
- Albumin greater than or equal to 2.5 g/dL
Key exclusion criteria (10 listed)
- Uncontrolled cardiac disease, angina, congestive heart failure, or myocardial infarction within 6 months prior to Study Day
- Known history of hepatitis B or C, or HIV infection
- Clinically significant effusions, including pericardial, pleural, and ascites
- Serious non-malignant disease
- Central nervous system (CNS) metastatic involvement except where the disease has been successfully treated
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 |
|---|---|---|
| hCBE-11 | Drug | – |
Primary outcome
To evaluate the safety and tolerability of hCBE-11 in advanced solid tumors
Time frame: up to 2 years
1 secondary outcome
To define the recommended Phase II dose of hCBE-11
Time frame: up to 2 years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2013.
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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.
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 hCBE-11 in people with Tumors, run by Biogen 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 7 inclusion and 10 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: stopped early, as of the sponsor's last update on 26 Apr 2013. 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 was stopped early. Results are not available in the source record.
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?
To evaluate the safety and tolerability of hCBE-11 in advanced solid tumors (time frame: up to 2 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 26 Apr 2013.