CancerPhase 1NCT01413906
Phase 1 Multiple Ascending Dose Study of BMS-833923 (XL139) in Subjects With Solid Tumors
A Phase 1 study testing BMS-833923 (XL139) in people with Cancer, run by Bristol-Myers Squibb at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate the tolerability and safety profile of BMS-833923 (XL139) when orally administered on a once daily schedule. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- BMS-833923 (XL139)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteJapan
- Study dates
- Nov 2011to Nov 2012
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with advanced or metastatic solid tumors refractory to, or relapsed from, standard therapies or for which there is no known effective treatment
- Men and woman, 20 years of age and above
Who cannot join
- Subjects with symptomatic brain metastasis or active brain metastasis requiring treatments
- Inability to swallow oral medication
- Uncontrolled or significant cardiovascular disease
- Inadequate bone marrow function
- Inadequate hepatic function
- Inadequate renal function
- Pancreatitis
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the tolerability and safety profile of BMS-833923 (XL139) when orally administered on a once daily schedule.
- Conditions
- Cancer
- Being tested
- BMS-833923 (XL139)
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-833923 (XL139)Drug
Also called (XL139)
Capsule, Oral, 150 mg, 300 mg, or 450 mg,Once daily, Until progression of disease, unacceptable toxicity, withdrawal of subject's consent or meeting other discontinuation criteria
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: BMS-833923 (XL139) | Experimental | Not described Receives: Drug: BMS-833923 (XL139) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose Limiting Toxicity (DLT) and observed adverse events
Measured: Within the first 28 days of treatment
Incidence of Dose Limiting Toxicity (DLT) and observed adverse events
Measured: Up to 90 days additional treatment period plus 60 days of follow-up
Secondary outcomes (8)
The number of subjects experienced DLT
Measured: Within the first 28 days
Maximum observed concentration (Cmax) of BMS-833923 (XL139)
Measured: Day1 and Day 29
Trough observed concentration (Cmin) of BMS-833923 (XL139)
Measured: Day1 and Day 29
Time of maximum observed concentration (Tmax) of BMS-833923 (XL139)
Measured: Day1 and Day 29
Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-833923 (XL139)
Measured: Day1 and Day 29
Effective half-life (T-half,eff) of BMS-833923 (XL139)
Measured: Day1 and Day 29
Accumulation index (AI) of BMS-833923 (XL139)
Measured: Day1 and Day 29
Best overall response assessed according to Response evaluation criteria in solid tumors (RECIST) v1.1 criteria
Measured: Up to120 days of treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2011 (estimated)
- Study startNov 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01413906
- Sponsor's protocol ID
- CA194-010
- Status last verified
- May 2013
- First submitted
- 4 Aug 2011
- Last updated
- 3 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Multiple Ascending Dose Study of BMS-833923 (XL139) in Subjects With Solid Tumors
- ClinicalTrials.gov ID
- NCT01413906
- Acronym / sponsor ID
- CA194-010
- Conditions
- Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 10 Aug 2011 (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 study is to evaluate the tolerability and safety profile of BMS-833923 (XL139) when orally administered on a once daily schedule.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1: BMS-833923 (XL139) | Experimental | Drug: BMS-833923 (XL139) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects with advanced or metastatic solid tumors refractory to, or relapsed from, standard therapies or for which there is no known effective treatment
- Men and woman, 20 years of age and above
Key exclusion criteria (7 listed)
- Subjects with symptomatic brain metastasis or active brain metastasis requiring treatments
- Inability to swallow oral medication
- Uncontrolled or significant cardiovascular disease
- Inadequate bone marrow function
- Inadequate hepatic function
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-833923 (XL139)Also: (XL139)Capsule, Oral, 150 mg, 300 mg, or 450 mg,Once daily, Until progression of disease, unacceptable toxicity, withdrawal of subject's consent or meeting other discontinuation criteria | Drug | Arm 1: BMS-833923 (XL139) |
Primary outcome
Incidence of Dose Limiting Toxicity (DLT) and observed adverse events
Time frame: Within the first 28 days of treatment
Incidence of Dose Limiting Toxicity (DLT) and observed adverse events
Time frame: Up to 90 days additional treatment period plus 60 days of follow-up
8 secondary outcomes
The number of subjects experienced DLT
Time frame: Within the first 28 days
Maximum observed concentration (Cmax) of BMS-833923 (XL139)
Time frame: Day1 and Day 29
Trough observed concentration (Cmin) of BMS-833923 (XL139)
Time frame: Day1 and Day 29
Time of maximum observed concentration (Tmax) of BMS-833923 (XL139)
Time frame: Day1 and Day 29
Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-833923 (XL139)
Time frame: Day1 and Day 29
Effective half-life (T-half,eff) of BMS-833923 (XL139)
Time frame: Day1 and Day 29
Accumulation index (AI) of BMS-833923 (XL139)
Time frame: Day1 and Day 29
Best overall response assessed according to Response evaluation criteria in solid tumors (RECIST) v1.1 criteria
Time frame: Up to120 days of treatment period
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 3 Jun 2013.
Related trials for Cancer
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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
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 BMS-833923 (XL139) in people with Cancer, run by Bristol-Myers Squibb at 1 site in Japan.
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 2 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 3 Jun 2013. 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 Japan. 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?
Incidence of Dose Limiting Toxicity (DLT) and observed adverse events (time frame: Within the first 28 days of treatment). 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 3 Jun 2013.