TumorsPhase 1NCT00207025
A Phase I Study of BMS-275183 Given on a Daily Schedule in Patients With Advanced Malignancies
A Phase 1 study testing BMS-275183 in people with Tumors, run by Bristol-Myers Squibb at 3 sites in 2 countries.
Trial summary
The purpose of this clinical research study is to learn about the safety and tolerability of daily BMS-275183 in patients with advanced cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumors
- What is being tested?
- BMS-275183
- How many people
- 60 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Oct 2004to Feb 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
- Non-hematologic malignancy that has progressed or no standard therapy is known
- Four weeks from last chemotherapy or two weeks from last non-cytotoxic therapy
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- No more than 3 prior chemotherapy regimens in advanced/metastatic setting
- Absolute neutrophil count >=1,500/mm3 and platelets >=100,000/mm3
- Bilirubin <=1.5 x Upper Limit of Normal (ULN), Aspartate aminotransferase <=2.5 x ULN
Show all 9Show fewer
- Serum creatinine <=1.5 x ULN
- Men and women >=18 years
- Women of Child Bearing Potential (WOCBP) must use adequate method of contraception throughout and up to 4 weeks after the study
Who cannot join
- WOCBP and men not using adequate method of birth control
- WOCBP who are pregnant or breastfeeding
- Prior radiation >=25% of bone marrow containing skeleton
- Uncontrolled, significant, or active cardiovascular or pulmonary disease or infection or psychiatric disorder
- Neuropathy
- Active brain metastases
Show all 9Show fewer
- Inability to swallow capsules
- History of gastrointestinal disease, surgery or malabsorption, or requiring use of a feeding tube
- Concurrent chemotherapy, hormonal therapy, immunotherapy, or radiotherapy
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Local Institution
Detroit, Michigan
Local Institution
Pittsburgh, Pennsylvania
About this study
The purpose of this clinical research study is to learn about the safety and tolerability of daily BMS-275183 in patients with advanced cancer.
- Conditions
- Tumors
- Being tested
- BMS-275183
- Keywords
- Patients with advanced solid tumors
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-275183Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
Secondary outcomes (1)
PK, preliminary evidence of antitumor activity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startOct 2004
- Primary completionFeb 2007
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 Bristol-Myers SquibbThe 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
- 60 participants
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00207025
- Sponsor's protocol ID
- CA165-012
- Status last verified
- Jul 2008
- First submitted
- 12 Sep 2005
- Last updated
- 2 Mar 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of BMS-275183 Given on a Daily Schedule in Patients With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT00207025
- Acronym / sponsor ID
- CA165-012
- Conditions
- Tumors
- Keywords
- Patients with advanced solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 60 participants
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- Feb 2007 (actual)
- First posted
- 21 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 clinical research study is to learn about the safety and tolerability of daily BMS-275183 in patients with advanced cancer.
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 (9 listed)
- Non-hematologic malignancy that has progressed or no standard therapy is known
- Four weeks from last chemotherapy or two weeks from last non-cytotoxic therapy
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- No more than 3 prior chemotherapy regimens in advanced/metastatic setting
- Absolute neutrophil count >=1,500/mm3 and platelets >=100,000/mm3
Key exclusion criteria (9 listed)
- WOCBP and men not using adequate method of birth control
- WOCBP who are pregnant or breastfeeding
- Prior radiation >=25% of bone marrow containing skeleton
- Uncontrolled, significant, or active cardiovascular or pulmonary disease or infection or psychiatric disorder
- Neuropathy
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 |
|---|---|---|
| BMS-275183 | Drug | – |
Primary outcome
Safety and Tolerability
1 secondary outcome
PK, preliminary evidence of antitumor activity
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 2 Mar 2010.
Related trials for Tumors
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-275183 in people with Tumors, run by Bristol-Myers Squibb at 3 sites in 2 countries.
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 9 inclusion and 9 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 2 Mar 2010. 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, Belgium. 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?
Safety and Tolerability. 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 2 Mar 2010.