Solid TumorsPhase 1NCT01018966
Study of Ixabepilone (BMS-247550) in Patients With Solid Tumors
A Phase 1 study testing Ixabepilone in people with Solid Tumors, run by R-Pharm.
Trial summary
The purpose of this study is to determine the DLT, MTD and recommended Phase II dose of ixabepilone in Japanese patients with solid tumors. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Solid Tumors
- What is being tested?
- Ixabepilone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Apr 2004to Apr 2005
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20 years or older
- Histologically or cytologically confirmed diagnosis of adenocarcinoma Solid tumors
Who cannot join
- Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≥2
About this study
Official title: Phase I Study of Ixabepilone (BMS-247550) in Patients With Solid Tumors
The purpose of this study is to determine the DLT, MTD and recommended Phase II dose of ixabepilone in Japanese patients with solid tumors.
- Conditions
- Solid Tumors
- Being tested
- Ixabepilone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IxabepiloneDrug
Also called Ixempra, BMS-247550
Lyophilized and solvent, IV, 10-50 mg/m2, Q3W, At least 1 cycle, (21 days)
| Study group | Role | What they receive |
|---|---|---|
| Ixabepilone | Experimental | Not described Receives: Drug: Ixabepilone |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish the maximum tolerated dose (MTD), and a recommended Phase II dose of Ixabepilone when administered every three weeks by assessing status of treatment, dose intensity, and dose-limiting toxicities (DLT)
Measured: 3-week treatment cycles until unacceptable toxicity
Secondary outcomes (3)
To evaluate safety by assessing adverse events. Toxicity will be evaluated according to the Common Toxicity Criteria Version 3.0 (CTC). Response will be evaluated according to the RECIST (Response Evaluation Criteria in Solid Tumors) criteria
Measured: 3-week treatment cycles
To evaluate the plasma pharmacokinetics of Ixabepilone according to the following parameters: Cmax, AUC(INF), Tmax, t1/2, MRT(INF), Vss, Cltot
Measured: Cycle 1 (first 3 weeks of study therapy)
To describe any preliminary evidence of anti-tumor activity (response), assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST)
Measured: 3-week treatment cycles until unacceptable toxicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startApr 2004
- Primary completionMar 2005
- Study completionApr 2005
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.
- 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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- R-Pharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01018966
- Sponsor's protocol ID
- CA163-029
- Status last verified
- Jan 2017
- First submitted
- 24 Nov 2009
- Last updated
- 30 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Ixabepilone (BMS-247550) in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT01018966
- Acronym / sponsor ID
- CA163-029
- Conditions
- Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- R-PharmIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Primary completion
- Mar 2005 (actual)
- Study completion
- Apr 2005 (actual)
- First posted
- 25 Nov 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.
The purpose of this study is to determine the DLT, MTD and recommended Phase II dose of ixabepilone in Japanese patients with solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ixabepilone | Experimental | Drug: Ixabepilone |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 20 years or older
- Histologically or cytologically confirmed diagnosis of adenocarcinoma Solid tumors
Key exclusion criteria (1 listed)
- Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≥2
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 |
|---|---|---|
| IxabepiloneAlso: Ixempra, BMS-247550Lyophilized and solvent, IV, 10-50 mg/m2, Q3W, At least 1 cycle, (21 days) | Drug | Ixabepilone |
Primary outcome
To establish the maximum tolerated dose (MTD), and a recommended Phase II dose of Ixabepilone when administered every three weeks by assessing status of treatment, dose intensity, and dose-limiting toxicities (DLT)
Time frame: 3-week treatment cycles until unacceptable toxicity
3 secondary outcomes
To evaluate safety by assessing adverse events. Toxicity will be evaluated according to the Common Toxicity Criteria Version 3.0 (CTC). Response will be evaluated according to the RECIST (Response Evaluation Criteria in Solid Tumors) criteria
Time frame: 3-week treatment cycles
To evaluate the plasma pharmacokinetics of Ixabepilone according to the following parameters: Cmax, AUC(INF), Tmax, t1/2, MRT(INF), Vss, Cltot
Time frame: Cycle 1 (first 3 weeks of study therapy)
To describe any preliminary evidence of anti-tumor activity (response), assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: 3-week treatment cycles until unacceptable toxicity
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 30 Jan 2017.
Related trials for Solid Tumors
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ixabepilone in people with Solid Tumors, run by R-Pharm.
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 1 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 30 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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 establish the maximum tolerated dose (MTD), and a recommended Phase II dose of Ixabepilone when administered every three weeks by assessing status of treatment, dose intensity, and dose-limiting toxicities (DLT) (time frame: 3-week treatment cycles until unacceptable toxicity). 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 30 Jan 2017.