Advanced CancerPhase 1NCT00798252
Ascending Multiple-Dose Study of Brivanib Alaninate in Combination With Chemotherapeutic Agents in Subjects With Advanced Cancers
A Phase 1 study testing Capecitabine, Doxorubicin and Ixabepilone in people with Advanced Cancer, run by Bristol-Myers Squibb at 5 sites in 2 countries.
Trial summary
To determine safety and maximum tolerated dose of brivanib alaninate when administered in combination with capecitabine, doxorubicin, ixabepilone, docetaxel and paclitaxel chemotherapy to subjects with advanced or metastatic solid tumors Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- Capecitabine, Doxorubicin and Ixabepilone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Mar 2009to May 2015
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic/cytologic diagnosis of advanced or metastatic solid tumors
- Life expectancy >= 3 months
- Able to swallow tablets/capsules
Who cannot join
- Pregnant or breastfeeding women
- No more than 4 previous chemotherapy regimens in the advanced or metastatic setting (excluding prior adjuvant or hormonal / immuno / biologic antibody therapies
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States3 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Wayne State University
Detroit, Michigan, 48201
Usc/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Canada2 sites
Local Institution
Edmonton, Alberta, T6G 1Z2
Local Institution
Toronto, Ontario, M5G 2M9
About this study
Official title: A Phase I, Multi-arm, Dose Escalation Study of Brivanib Alaninate Combined With Several Chemotherapy Regimens in Subjects With Solid Tumors
To determine safety and maximum tolerated dose of brivanib alaninate when administered in combination with capecitabine, doxorubicin, ixabepilone, docetaxel and paclitaxel chemotherapy to subjects with advanced or metastatic solid tumors
- Conditions
- Advanced Cancer
- Being tested
- Capecitabine, Doxorubicin, Ixabepilone, Docetaxel, Paclitaxel
- Keywords
- metastatic, chemotherapy combination
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
Also called Xleoda®
Tablets, Oral, Dose escalation to a MTD from a starting dose of 850 mg/m², twice a day (BID) x 14d per cycle, until disease progression
DoxorubicinDrug
Also called Adriamycin®
IV, Dose escalation to a MTD from a starting dose of 40 mg/m², Q3wks, until disease progression
IxabepiloneDrug
Also called IXEMPRA®, BMS-247550
IV, Dose Escalation to a MTD from a starting dose of 32 mg/m², Q3wks, until disease progression
DocetaxelDrug
Also called Taxotere®
IV, Dose escalation to an MTD from a starting dose of 60 mg/m², Q3wks, Until disease progression
PaclitaxelDrug
Also called Taxol®
IV, Dose escalation to an MTD from a starting dose of Paclitaxel 135 mg/m², Q3wks, Until disease progression
Brivanib alaninateDrug
Also called BMS-540215
Tablets, Oral, Dose escalation to a MTD from a starting dose of 400 mg, daily (QD), until disease progression
| Study group | Role | What they receive |
|---|---|---|
| Arm A (Capecitabine + Brivanib alaninate) | Experimental | Not described Receives: Drug: Capecitabine; Drug: Brivanib alaninate |
| Arm B (Doxorubicin + Brivanib alaninate) | Experimental | Not described Receives: Drug: Doxorubicin; Drug: Brivanib alaninate |
| Arm C (Ixabepilone + Brivanib alaninate) | Experimental | Not described Receives: Drug: Ixabepilone; Drug: Brivanib alaninate |
| Arm D (Docetaxel + Brivanib alaninate) | Experimental | Not described Receives: Drug: Docetaxel; Drug: Brivanib alaninate |
| Arm E (Paclitaxel + Brivanib alaninate) | Experimental | Not described Receives: Drug: Paclitaxel; Drug: Brivanib alaninate |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine safety and the maximum tolerated dose of brivanib alaninate when administered in combination with capecitabine, doxorubicin, ixabepilone, docetaxel and paclitaxel chemotherapy to subjects with advanced or metastatic solid tumors
Measured: Every 21 days until the maximum tolerated dose (MTD) for each combination of brivanib is reached
Secondary outcomes (3)
To describe the anti-tumor activity of brivanib alaninate combination with the different chemotherapeutic regimens: capecitabine, doxorubicin, ixabepilone, docetaxel, and paclitaxel
Measured: Every 21 days
To assess the effect each of capecitabine, doxorubicin, ixabepilone, docetaxel, and paclitaxel on the pharmacokinetics of BMS-540215 (active moiety of brivanib pro-drug) at the MTD
Measured: Cycle 1D21, Days 1, 2, 3, 8 of Cycles 1 & 2
To assess the effect of brivanib alaninate on the pharmacokinetics each of capecitabine, doxorubicin, ixabepilone, docetaxel, and paclitaxel chemotherapy regimens at the MTD
Measured: Cycle 1D21, Days 1, 2, 3, 8 of Cycles 1 & 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2008 (estimated)
- Study startMar 2009
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 111 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
- NCT00798252
- Sponsor's protocol ID
- CA182-030
- Other IDs
- 2007-005097-31
- Status last verified
- Jul 2015
- First submitted
- 25 Nov 2008
- Last updated
- 7 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multi-arm, Dose Escalation Study of Brivanib Alaninate Combined With Several Chemotherapy Regimens in Subjects With Solid Tumors
- ClinicalTrials.gov ID
- NCT00798252
- Acronym / sponsor ID
- CA182-030
- Conditions
- Advanced Cancer
- Keywords
- metastatic, chemotherapy combination
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 26 Nov 2008 (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 and maximum tolerated dose of brivanib alaninate when administered in combination with capecitabine, doxorubicin, ixabepilone, docetaxel and paclitaxel chemotherapy to subjects with advanced or metastatic solid tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm A (Capecitabine + Brivanib alaninate) | Experimental | Drug: Capecitabine, Drug: Brivanib alaninate |
| Arm B (Doxorubicin + Brivanib alaninate) | Experimental | Drug: Doxorubicin, Drug: Brivanib alaninate |
| Arm C (Ixabepilone + Brivanib alaninate) | Experimental | Drug: Ixabepilone, Drug: Brivanib alaninate |
| Arm D (Docetaxel + Brivanib alaninate) | Experimental | Drug: Docetaxel, Drug: Brivanib alaninate |
| Arm E (Paclitaxel + Brivanib alaninate) | Experimental | Drug: Paclitaxel, Drug: Brivanib alaninate |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologic/cytologic diagnosis of advanced or metastatic solid tumors
- Life expectancy >= 3 months
- Able to swallow tablets/capsules
Key exclusion criteria (2 listed)
- Pregnant or breastfeeding women
- No more than 4 previous chemotherapy regimens in the advanced or metastatic setting (excluding prior adjuvant or hormonal / immuno / biologic antibody therapies
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 |
|---|---|---|
| CapecitabineAlso: Xleoda®Tablets, Oral, Dose escalation to a MTD from a starting dose of 850 mg/m², twice a day (BID) x 14d per cycle, until disease progression | Drug | Arm A (Capecitabine + Brivanib alaninate) |
| DoxorubicinAlso: Adriamycin®IV, Dose escalation to a MTD from a starting dose of 40 mg/m², Q3wks, until disease progression | Drug | Arm B (Doxorubicin + Brivanib alaninate) |
| IxabepiloneAlso: IXEMPRA®, BMS-247550IV, Dose Escalation to a MTD from a starting dose of 32 mg/m², Q3wks, until disease progression | Drug | Arm C (Ixabepilone + Brivanib alaninate) |
| DocetaxelAlso: Taxotere®IV, Dose escalation to an MTD from a starting dose of 60 mg/m², Q3wks, Until disease progression | Drug | Arm D (Docetaxel + Brivanib alaninate) |
| PaclitaxelAlso: Taxol®IV, Dose escalation to an MTD from a starting dose of Paclitaxel 135 mg/m², Q3wks, Until disease progression | Drug | Arm E (Paclitaxel + Brivanib alaninate) |
| Brivanib alaninateAlso: BMS-540215Tablets, Oral, Dose escalation to a MTD from a starting dose of 400 mg, daily (QD), until disease progression | Drug | Arm A (Capecitabine + Brivanib alaninate), Arm B (Doxorubicin + Brivanib alaninate), Arm C (Ixabepilone + Brivanib alaninate), Arm D (Docetaxel + Brivanib alaninate), Arm E (Paclitaxel + Brivanib alaninate) |
Primary outcome
To determine safety and the maximum tolerated dose of brivanib alaninate when administered in combination with capecitabine, doxorubicin, ixabepilone, docetaxel and paclitaxel chemotherapy to subjects with advanced or metastatic solid tumors
Time frame: Every 21 days until the maximum tolerated dose (MTD) for each combination of brivanib is reached
3 secondary outcomes
To describe the anti-tumor activity of brivanib alaninate combination with the different chemotherapeutic regimens: capecitabine, doxorubicin, ixabepilone, docetaxel, and paclitaxel
Time frame: Every 21 days
To assess the effect each of capecitabine, doxorubicin, ixabepilone, docetaxel, and paclitaxel on the pharmacokinetics of BMS-540215 (active moiety of brivanib pro-drug) at the MTD
Time frame: Cycle 1D21, Days 1, 2, 3, 8 of Cycles 1 & 2
To assess the effect of brivanib alaninate on the pharmacokinetics each of capecitabine, doxorubicin, ixabepilone, docetaxel, and paclitaxel chemotherapy regimens at the MTD
Time frame: Cycle 1D21, Days 1, 2, 3, 8 of Cycles 1 & 2
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 7 Jul 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
5 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 Capecitabine, Doxorubicin and Ixabepilone in people with Advanced Cancer, run by Bristol-Myers Squibb at 5 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 3 inclusion and 2 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 7 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Canada. 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 safety and the maximum tolerated dose of brivanib alaninate when administered in combination with capecitabine, doxorubicin, ixabepilone, docetaxel and paclitaxel chemotherapy to subjects with advanced or metastatic solid tumors (time frame: Every 21 days until the maximum tolerated dose (MTD) for each combination of brivanib 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 7 Jul 2015.