MalignanciesPhase 1NCT00320827
Study of CS-1008 in Patients With Advanced Solid Malignancies and Lymphomas (Without Leukemic Component)
A Phase 1 study testing CS-1008 (humanized anti-DR5 antibody) in people with Malignancies and Lymphoma, run by Daiichi Sankyo at 1 site in United States.
Trial summary
This is a dose escalation study of CS-1008 (humanized anti-DR5 antibody) to determine the recommended Phase 2 dose and the maximum tolerated dose. Drug will be administered for six weeks and possibly up to 12 weeks depending on response. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignancies, Lymphoma
- What is being tested?
- CS-1008 (humanized anti-DR5 antibody)
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically diagnosed metastatic solid tumors or lymphomas (with no leukemic component) which are refractory to, not curable with, or not eligible for standard treatment(s).
- Eighteen years of age or older
- Eastern Cooperative Oncology Group (ECOG) performance status equal to or less than 2
- Resolution of any toxic effects (except alopecia) of prior therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0 grade of equal to or less than 1
- Men and women of childbearing potential must be willing to consent to use effective contraception while on treatment and for at least 3 months thereafter.
- All female patients of childbearing potential must have a negative pregnancy test (serum or urine) within 3 days prior to treatment
- Patients must be fully informed about their illness and the investigational nature of the study protocol
Who cannot join
- Anticipation of the need for a major surgical procedure or radiation therapy during the study
- Treatment with chemotherapy, hormonal therapy, radiotherapy, major surgery, or any investigational agent within 4 weeks (6 weeks for nitrosoureas, mitomycin C, immunotherapy, biological therapy, or major surgery) of study enrollment
- Cumulative radiation therapy to greater than 25% of the total bone marrow
- Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) class III or IV congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or other clinically significant thromboembolytic event; clinically significant pulmonary disease (e.g., severe chronic obstructive pulmonary disease [COPD] or asthma)
- Patients with a clinically active brain metastasis (i.e., not treated or still requiring therapy with steroids or radiotherapy [RT]; or with progression 4 weeks after the completion of RT) or an uncontrolled seizure disorder, spinal cord compression, or carcinomatous meningitis
- Clinically significant active infection which requires antibiotic therapy, or HIV-positive patients receiving antiretroviral therapy.
- Chronic diarrhea, inflammatory bowel disease, or partial bowel obstruction
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294-3300
About this study
Official title: Phase 1 Study of CS-1008, a Humanized Monoclonal Antibody Targeting Death Receptor 5 (DR5), Administered Weekly to Patients With Advanced Solid Malignancies and Lymphomas (Without Leukemic Component)
This is a dose escalation study of CS-1008 (humanized anti-DR5 antibody) to determine the recommended Phase 2 dose and the maximum tolerated dose. Drug will be administered for six weeks and possibly up to 12 weeks depending on response.
- Conditions
- Malignancies, Lymphoma
- Being tested
- CS-1008 (humanized anti-DR5 antibody)
- Keywords
- Apoptosis, Death receptor 5, Cancer, Advanced solid malignancies and lymphomas (without leukemic component)
- Medical subject headings
- Neoplasms, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CS-1008 (humanized anti-DR5 antibody)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the recommended Phase 2 dose
Secondary outcomes (4)
To investigate the pharmacokinetics of CS-1008 administered weekly
To characterize the immunogenicity of CS-1008 by monitoring for anti-CS-1008 antibodies
To study potential biomarkers of CS-1008 activity
To make preliminary assessments of anti-tumor effects of CS-1008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalignanciesStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00320827
- Sponsor's protocol ID
- CS1008-A-U101
- Status last verified
- Sep 2007
- First submitted
- 28 Apr 2006
- Last updated
- 11 Sep 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of CS-1008, a Humanized Monoclonal Antibody Targeting Death Receptor 5 (DR5), Administered Weekly to Patients With Advanced Solid Malignancies and Lymphomas (Without Leukemic Component)
- ClinicalTrials.gov ID
- NCT00320827
- Acronym / sponsor ID
- CS1008-A-U101
- Conditions
- Malignancies, Lymphoma
- Keywords
- Apoptosis, Death receptor 5, Cancer, Advanced solid malignancies and lymphomas (without leukemic component)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- First posted
- 3 May 2006 (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 dose escalation study of CS-1008 (humanized anti-DR5 antibody) to determine the recommended Phase 2 dose and the maximum tolerated dose. Drug will be administered for six weeks and possibly up to 12 weeks depending on response.
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)
- Histologically or cytologically diagnosed metastatic solid tumors or lymphomas (with no leukemic component) which are refractory to, not curable with, or not eligible for standard treatment(s).
- Eighteen years of age or older
- Eastern Cooperative Oncology Group (ECOG) performance status equal to or less than 2
- Resolution of any toxic effects (except alopecia) of prior therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0 grade of equal to or less than 1
- Men and women of childbearing potential must be willing to consent to use effective contraception while on treatment and for at least 3 months thereafter.
Key exclusion criteria (7 listed)
- Anticipation of the need for a major surgical procedure or radiation therapy during the study
- Treatment with chemotherapy, hormonal therapy, radiotherapy, major surgery, or any investigational agent within 4 weeks (6 weeks for nitrosoureas, mitomycin C, immunotherapy, biological therapy, or major surgery) of study enrollment
- Cumulative radiation therapy to greater than 25% of the total bone marrow
- Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) class III or IV congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or other clinically significant thromboembolytic event; clinically significant pulmonary disease (e.g., severe chronic obstructive pulmonary disease [COPD] or asthma)
- Patients with a clinically active brain metastasis (i.e., not treated or still requiring therapy with steroids or radiotherapy [RT]; or with progression 4 weeks after the completion of RT) or an uncontrolled seizure disorder, spinal cord compression, or carcinomatous meningitis
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 |
|---|---|---|
| CS-1008 (humanized anti-DR5 antibody) | Drug | – |
Primary outcome
To determine the recommended Phase 2 dose
4 secondary outcomes
To investigate the pharmacokinetics of CS-1008 administered weekly
To characterize the immunogenicity of CS-1008 by monitoring for anti-CS-1008 antibodies
To study potential biomarkers of CS-1008 activity
To make preliminary assessments of anti-tumor effects of CS-1008
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 11 Sep 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CS-1008 (humanized anti-DR5 antibody) in people with Malignancies and Lymphoma, run by Daiichi Sankyo 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 7 inclusion and 7 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 11 Sep 2007. 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 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 determine the recommended Phase 2 dose. 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 11 Sep 2007.