Solid TumorsPhase 1NCT00674947
A Phase I Study of BIIB015 in Relapsed/Refractory Solid Tumors
A Phase 1 study testing BIIB015 in people with Solid Tumors, run by Biogen at 3 sites in United States.
Trial summary
Phase 1, open-labeled, safety and tolerability study for the treatment of subjects with relapsed or refractory solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- BIIB015
- Type of treatment
- Injection or infusion
- How many people
- 55 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2008to Jun 2011
- 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
- Age 18 years or older at the time of informed consent.
- Solid tumors that are relapsed or refractory to at least 1 prior anti-cancer systemic therapy and for which no standard therapy exists.
- ECOG Performance Status </= 2.
Who cannot join
- History of keratoconjunctivitis, open or closed angle glaucoma, or "dry eye" disease.
- New York Heart Association (NYHA) Grade II or greater congestive heart failure.
- History of myocardial infarction within 6 months prior to Day 1.
- Presence of >/= Grade 2 peripheral neuropathy.
- Known presence of central nervous system or brain metastases.
- Prior therapy with a conjugated or unconjugated maytansine derivative.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Research Site
Philadelphia, Pennsylvania
Research Site
San Antonio, Texas
Research Site
Santa Monica, California
About this study
Official title: A Phase I Study of BIIB015, a Humanized, IgG1, DM4-Conjugated, Anti-Cripto, Monoclonal Antibody, for the Treatment of Subjects With Relapsed or Refractory Solid Tumors
Phase 1, open-labeled, safety and tolerability study for the treatment of subjects with relapsed or refractory solid tumors.
- Conditions
- Solid Tumors
- Being tested
- BIIB015
- Keywords
- Relapsed, Refractory
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIIB015Drug
IV infusion once every 3 weeks until disease progression or unacceptable toxicity
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate safety
Measured: ongoing
To determine the maximum-tolerated dose (MTD)
Measured: ongoing
Secondary outcomes (2)
To evaluate pharmacokinetics (PK)
Measured: ongoing
To evaluate clinical activity
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2008 (estimated)
- Study startJun 2008
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid 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
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00674947
- Sponsor's protocol ID
- 207ST101
- Status last verified
- Sep 2011
- First submitted
- 6 May 2008
- Last updated
- 16 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of BIIB015, a Humanized, IgG1, DM4-Conjugated, Anti-Cripto, Monoclonal Antibody, for the Treatment of Subjects With Relapsed or Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT00674947
- Acronym / sponsor ID
- 207ST101
- Conditions
- Solid Tumors
- Keywords
- Relapsed, Refractory
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 8 May 2008 (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.
Phase 1, open-labeled, safety and tolerability study for the treatment of subjects with relapsed or refractory solid tumors.
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)
- Age 18 years or older at the time of informed consent.
- Solid tumors that are relapsed or refractory to at least 1 prior anti-cancer systemic therapy and for which no standard therapy exists.
- ECOG Performance Status </= 2.
Key exclusion criteria (6 listed)
- History of keratoconjunctivitis, open or closed angle glaucoma, or "dry eye" disease.
- New York Heart Association (NYHA) Grade II or greater congestive heart failure.
- History of myocardial infarction within 6 months prior to Day 1.
- Presence of >/= Grade 2 peripheral neuropathy.
- Known presence of central nervous system or brain metastases.
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 |
|---|---|---|
| BIIB015IV infusion once every 3 weeks until disease progression or unacceptable toxicity | Drug | – |
Primary outcome
To evaluate safety
Time frame: ongoing
To determine the maximum-tolerated dose (MTD)
Time frame: ongoing
2 secondary outcomes
To evaluate pharmacokinetics (PK)
Time frame: ongoing
To evaluate clinical activity
Time frame: ongoing
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 16 Sep 2013.
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
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Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
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 BIIB015 in people with Solid 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 3 inclusion and 6 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 16 Sep 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 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?
To evaluate safety (time frame: ongoing). The study lists 2 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 16 Sep 2013.