Refractory Hematologic CancerPhase 1/2NCT00838890
A Study of BMS-863233 in Patients With Hematologic Cancer
A Phase 1/2 study testing Cdc7-inhibitor (BMS-863233) in people with Refractory Hematologic Cancer, run by Bristol-Myers Squibb at 4 sites in United States.
Trial summary
To determine safety, tolerability and maximum tolerated dose of BMS-63233/XL413 in subjects with Refractory Hematologic Cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Hematologic Cancer
- What is being tested?
- Cdc7-inhibitor (BMS-863233)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 4 sitesUnited States
- Study dates
- Mar 2009to Jan 2010
- Phase
- Phase 1/2
- 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
- AML by current WHO diagnostic criteria, any FAB type (except APML), Refractory ALL, Accelerated/blast phase CML and Refractory MDS with total IPSS score of 2 or higher
- ECOG performance status <= 2
- Accessible for treatment, PK sample collection and required study follow-up
- Total Bilirubin ≤ 1.5 x ULN and ALT, AST ≤ 3 x ULN
Who cannot join
- Women who are pregnant or breastfeeding
- Subjects with Acute Promyelocytic leukemia disease or CNS leukemia disease)
- Hyperleukocytosis (defined as peripheral WBC >50,000/uL)
- Treatment with any other investigational agent for any indication within 30 days of protocol enrollment
- Subjects a history of gastrointestinal disease
- Subjects less than four weeks from allogenic or autologous stem cell transplant infusion
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Roswell Park
Buffalo, New York, 14263
University Of Miami
Miami, Florida, 33136
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612
About this study
Official title: A Phase 1/2, Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-863233 in Subjects With Refractory Hematologic Malignancies
To determine safety, tolerability and maximum tolerated dose of BMS-63233/XL413 in subjects with Refractory Hematologic Cancer
- Conditions
- Refractory Hematologic Cancer
- Being tested
- Cdc7-inhibitor (BMS-863233)
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cdc7-inhibitor (BMS-863233)Drug
Also called BMS-863233
Tablets, Oral, QD x 14 days until MTD is achieved, 14 days per 28 day cycle/QD, 12 months
Cdc7-inhibitor (BMS-863233)Drug
Also called BMS-863233
Tablets, Oral, MTD of Cdc7-inhibitor (A) Arm, QD x 7 days until MTD achieved, 7 days per 21 day cycle/QD, 12 months
| Study group | Role | What they receive |
|---|---|---|
| Cdc7-inhibitor (A) | Active comparator | Not described Receives: Drug: Cdc7-inhibitor (BMS-863233) |
| Cdc7-inhibitor (B) | Active comparator | Not described Receives: Drug: Cdc7-inhibitor (BMS-863233) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine maximum tolerated dose and anti-tumor activity of BMS-863233/XL413 when administered to subjects with refractory Hematologic Cancer
Measured: Every 21 or 28 days until maximum tolerated dose is reached
Secondary outcomes (3)
To determine the safety of BMS-863233/XL413 when administered to subjects with refractory Hematologic Cancer
Measured: Every 21 or 28 days until the MTD is reached
To determine the pharmacokinetics of BMS-863233/XL413 when administered to subjects with refractory Hematologic Cancer
Measured: Every 21 or 28 days until the MTD is reached
To determine the anti-tumor activity of BMS-863233/XL413 when administered to subjects with refractory Hematologic Cancer
Measured: Every 21 or 28 days until the MTD is reached
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2009 (estimated)
- Study startMar 2009
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Hematologic CancerStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Exelixis
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00838890
- Sponsor's protocol ID
- CA198-001
- Status last verified
- Sep 2015
- First submitted
- 6 Feb 2009
- Last updated
- 12 Oct 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-863233 in Subjects With Refractory Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT00838890
- Acronym / sponsor ID
- CA198-001
- Conditions
- Refractory Hematologic Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Exelixis
- Study start
- Mar 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 9 Feb 2009 (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.
To determine safety, tolerability and maximum tolerated dose of BMS-63233/XL413 in subjects with Refractory Hematologic Cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cdc7-inhibitor (A) | Active comparator | Drug: Cdc7-inhibitor (BMS-863233) |
| Cdc7-inhibitor (B) | Active comparator | Drug: Cdc7-inhibitor (BMS-863233) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- AML by current WHO diagnostic criteria, any FAB type (except APML), Refractory ALL, Accelerated/blast phase CML and Refractory MDS with total IPSS score of 2 or higher
- ECOG performance status <= 2
- Accessible for treatment, PK sample collection and required study follow-up
- Total Bilirubin ≤ 1.5 x ULN and ALT, AST ≤ 3 x ULN
Key exclusion criteria (6 listed)
- Women who are pregnant or breastfeeding
- Subjects with Acute Promyelocytic leukemia disease or CNS leukemia disease)
- Hyperleukocytosis (defined as peripheral WBC >50,000/uL)
- Treatment with any other investigational agent for any indication within 30 days of protocol enrollment
- Subjects a history of gastrointestinal disease
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 |
|---|---|---|
| Cdc7-inhibitor (BMS-863233)Also: BMS-863233Tablets, Oral, QD x 14 days until MTD is achieved, 14 days per 28 day cycle/QD, 12 months | Drug | Cdc7-inhibitor (A) |
| Cdc7-inhibitor (BMS-863233)Also: BMS-863233Tablets, Oral, MTD of Cdc7-inhibitor (A) Arm, QD x 7 days until MTD achieved, 7 days per 21 day cycle/QD, 12 months | Drug | Cdc7-inhibitor (B) |
Primary outcome
To determine maximum tolerated dose and anti-tumor activity of BMS-863233/XL413 when administered to subjects with refractory Hematologic Cancer
Time frame: Every 21 or 28 days until maximum tolerated dose is reached
3 secondary outcomes
To determine the safety of BMS-863233/XL413 when administered to subjects with refractory Hematologic Cancer
Time frame: Every 21 or 28 days until the MTD is reached
To determine the pharmacokinetics of BMS-863233/XL413 when administered to subjects with refractory Hematologic Cancer
Time frame: Every 21 or 28 days until the MTD is reached
To determine the anti-tumor activity of BMS-863233/XL413 when administered to subjects with refractory Hematologic Cancer
Time frame: Every 21 or 28 days until the MTD is reached
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 12 Oct 2015.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cdc7-inhibitor (BMS-863233) in people with Refractory Hematologic Cancer, run by Bristol-Myers Squibb at 4 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 4 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: stopped early, as of the sponsor's last update on 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 determine maximum tolerated dose and anti-tumor activity of BMS-863233/XL413 when administered to subjects with refractory Hematologic Cancer (time frame: Every 21 or 28 days until maximum tolerated dose is reached). 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 12 Oct 2015.