Advanced Solid TumorsPhase 1NCT00793897
Multiple Dose Study In Cancer Patients: Safety and Tolerability of BMS-754807 in Combination With Paclitaxel and Carboplatin in Patients With Advanced or Metastatic Solid Tumors
A Phase 1 study testing BMS-754807, Paclitaxel and Carboplatin in people with Advanced Solid Tumors and Metastatic Solid Tumors, run by Bristol-Myers Squibb at 5 sites in 3 countries.
Trial summary
A Phase I dose escalation study to determine the safety, tolerability, pharmacodynamics and preliminary anti-tumor activity of BMS-754807 in combination with chemotherapy drugs, paclitaxel and carboplatin, in patients with advanced or metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors, Metastatic Solid Tumors
- What is being tested?
- BMS-754807, Paclitaxel and Carboplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Apr 2009to Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with advanced or metastatic solid tumors for whom carboplatin and paclitaxel is considered an appropriate therapy
- ECOG performance status 0-1
- At least 4 weeks between surgery or last dose prior anti-cancer therapy
Who cannot join
- Symptomatic brain metastases
- Any disorder or dysregulation of glucose homeostasis {e.g. diabetes)
- Uncontrolled or significant cardiovascular disease
- Inadequate bone marrow, liver or kidney function
- Evidence of > Grade 1 peripheral neuropathy
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Australia2 sites
Local Institution
East Melbourne, Victoria, 3002
Local Institution
Parville, Victoria, 3050
Canada2 sites
Local Institution
Edmonton, Alberta, T6G 1Z2
Local Institution
Hamilton, Ontario, L8V 5C2
About this study
Official title: A Phase I Multiple Ascending Dose Study of BMS-754807 in Combination With Paclitaxel and Carboplatin in Subjects With Advanced or Metastatic Solid Tumors
A Phase I dose escalation study to determine the safety, tolerability, pharmacodynamics and preliminary anti-tumor activity of BMS-754807 in combination with chemotherapy drugs, paclitaxel and carboplatin, in patients with advanced or metastatic solid tumors. In addition, the study is expected to identify the recommended dose or dose range of BMS-754807 in combination with paclitaxel and carboplatin for Phase 2 studies
- Conditions
- Advanced Solid Tumors, Metastatic Solid Tumors
- Being tested
- BMS-754807, Paclitaxel, Carboplatin
- Keywords
- Subjects with Advanced or Metastatic Solid Tumors or Neoplasms
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-754807Drug
Also called IGF-IR
Tablets, Oral, escalating doses starting at 10 mg, continuous or intermittent, until disease progression, unacceptable toxicity or at the subject's request
PaclitaxelDrug
Also called Taxol, BMS-181339
Vials, IV, 200 mg/m2, Day 1 of a 21-day cycle, until disease progression, unacceptable toxicity or at the subject's request
CarboplatinDrug
Also called Paraplatin, BMY-26575
Vials, IV, 6 mg/mL.min, Day 1 of a 21-day cycle, until disease progression, unacceptable toxicity or at the subject's request
| Study group | Role | What they receive |
|---|---|---|
| Sequential allocation of patients in two dosing schedules | Experimental | Not described Receives: Drug: BMS-754807; Drug: Paclitaxel; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Toxicities will be evaluated according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3
Measured: Continuous assessment throughout the duration of the trial: starting with dosing on Day 1 until after 30 day follow-up following the last dose
Secondary outcomes (4)
Pharmacodynamics: Biochemical parameters of drug action in serum
Measured: assessed every 6 weeks of the study
Metabolic measures: Effects of the drug on parameters of glucose homeostasis
Measured: assessed every 6 weeks of the study
Efficacy Measures: PET scans and tumor assessments by CT/MRI
Measured: a total of 3 PET scans at screening and during the first 3 weeks. CT/MRI assessed every 6 weeks
Pharmacokinetic Measures: Blood samples will be collected during pre-specified times
Measured: Day 2, 8 and 15 of Cycle 1 and on Day 1 or Cycle 2 (for Arm A subjects only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2008 (estimated)
- Study startApr 2009
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid 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
- 21 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
- NCT00793897
- Sponsor's protocol ID
- CA191-005
- Status last verified
- Jul 2012
- First submitted
- 17 Nov 2008
- Last updated
- 13 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Multiple Ascending Dose Study of BMS-754807 in Combination With Paclitaxel and Carboplatin in Subjects With Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT00793897
- Acronym / sponsor ID
- CA191-005
- Conditions
- Advanced Solid Tumors, Metastatic Solid Tumors
- Keywords
- Subjects with Advanced or Metastatic Solid Tumors or Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 19 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.
A Phase I dose escalation study to determine the safety, tolerability, pharmacodynamics and preliminary anti-tumor activity of BMS-754807 in combination with chemotherapy drugs, paclitaxel and carboplatin, in patients with advanced or metastatic solid tumors. In addition, the study is expected to identify the recommended dose or dose range of BMS-754807 in combination with paclitaxel and carboplatin for Phase 2 studies
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sequential allocation of patients in two dosing schedules | Experimental | Drug: BMS-754807, Drug: Paclitaxel, Drug: Carboplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects with advanced or metastatic solid tumors for whom carboplatin and paclitaxel is considered an appropriate therapy
- ECOG performance status 0-1
- At least 4 weeks between surgery or last dose prior anti-cancer therapy
Key exclusion criteria (5 listed)
- Symptomatic brain metastases
- Any disorder or dysregulation of glucose homeostasis {e.g. diabetes)
- Uncontrolled or significant cardiovascular disease
- Inadequate bone marrow, liver or kidney function
- Evidence of > Grade 1 peripheral 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-754807Also: IGF-IRTablets, Oral, escalating doses starting at 10 mg, continuous or intermittent, until disease progression, unacceptable toxicity or at the subject's request | Drug | Sequential allocation of patients in two dosing schedules |
| PaclitaxelAlso: Taxol, BMS-181339Vials, IV, 200 mg/m2, Day 1 of a 21-day cycle, until disease progression, unacceptable toxicity or at the subject's request | Drug | Sequential allocation of patients in two dosing schedules |
| CarboplatinAlso: Paraplatin, BMY-26575Vials, IV, 6 mg/mL.min, Day 1 of a 21-day cycle, until disease progression, unacceptable toxicity or at the subject's request | Drug | Sequential allocation of patients in two dosing schedules |
Primary outcome
Safety: Toxicities will be evaluated according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3
Time frame: Continuous assessment throughout the duration of the trial: starting with dosing on Day 1 until after 30 day follow-up following the last dose
4 secondary outcomes
Pharmacodynamics: Biochemical parameters of drug action in serum
Time frame: assessed every 6 weeks of the study
Metabolic measures: Effects of the drug on parameters of glucose homeostasis
Time frame: assessed every 6 weeks of the study
Efficacy Measures: PET scans and tumor assessments by CT/MRI
Time frame: a total of 3 PET scans at screening and during the first 3 weeks. CT/MRI assessed every 6 weeks
Pharmacokinetic Measures: Blood samples will be collected during pre-specified times
Time frame: Day 2, 8 and 15 of Cycle 1 and on Day 1 or Cycle 2 (for Arm A subjects only)
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 13 Jul 2012.
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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 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-754807, Paclitaxel and Carboplatin in people with Advanced Solid Tumors and Metastatic Solid Tumors, run by Bristol-Myers Squibb at 5 sites in 3 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 5 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 13 Jul 2012. 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 Australia, Canada, South Korea. 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?
Safety: Toxicities will be evaluated according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3 (time frame: Continuous assessment throughout the duration of the trial: starting with dosing on Day 1 until after 30 day follow-up following the last dose). 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 13 Jul 2012.