Advanced Solid TumorsPhase 1/2NCT00546247
A Phase 1/2 Study of Epofolate (BMS-753493) in Subjects With Advanced Cancer (Schedule 1)
A Phase 1/2 study testing Epofolate in people with Advanced Solid Tumors, run by Bristol-Myers Squibb at 4 sites in 2 countries.
Trial summary
The purpose of this clinical research study is to study the safety of Epofolate (BMS-753493) in patients with advanced cancers (in Phase 1 portion) and to determine whether Epofolate (BMS-753493) can shrink or slow the growth of the cancer in patients with advanced ovarian, renal or breast cancer (in Phase 2 portion). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- Epofolate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Jan 2008to Mar 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
- Advanced cancer, excluding cancer in the blood
- Availability of 10 tumor tissue slides
Who cannot join
- Known brain metastases
- Severe nerve damage
- Significant cardiovascular disease
- Inadequate blood counts
- Inadequate liver or kidney function
- Inadequate thyroid function or uncontrolled thyroid disease
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, 22057
About this study
Official title: A Phase 1/2, Ascending Multiple-Dose Study to Evaluate the Safety, Efficacy and Pharmacokinetics of BMS-753493 in Subjects With Advanced Cancer (Schedule 1)
The purpose of this clinical research study is to study the safety of Epofolate (BMS-753493) in patients with advanced cancers (in Phase 1 portion) and to determine whether Epofolate (BMS-753493) can shrink or slow the growth of the cancer in patients with advanced ovarian, renal or breast cancer (in Phase 2 portion).
- Conditions
- Advanced Solid Tumors
- Being tested
- Epofolate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpofolateDrug
Also called BMS-753493
Intravenous solution, intravenous, initially 3 patients will be treated and if there is a DLT then additional 3 patients will be treated in that dose level. 3-5 minute IV bolus on Days 1, 4, 8 and 11 of a 21-day cycle, until the disease progresses
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Epofolate |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the Maximum Tolerated Dose, the Dose Limiting Toxicity and the recommended dose of Epofolate (BMS-753493)
Measured: at the end of the study
Secondary outcomes (1)
To evaluate the safety and exposure levels of Epofolate (BMS-753493) in the body and the anticancer activity of Epofolate (BMS-753493)
Measured: every 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2007 (estimated)
- Study startJan 2008
- Primary completionMar 2010
- Study completionMar 2010
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 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
- NCT00546247
- Sponsor's protocol ID
- CA190-001
- Status last verified
- Sep 2015
- First submitted
- 17 Oct 2007
- Last updated
- 12 Oct 2015
- Results posted
- No
- Data monitoring committee
- 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, Ascending Multiple-Dose Study to Evaluate the Safety, Efficacy and Pharmacokinetics of BMS-753493 in Subjects With Advanced Cancer (Schedule 1)
- ClinicalTrials.gov ID
- NCT00546247
- Acronym / sponsor ID
- CA190-001
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 18 Oct 2007 (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 clinical research study is to study the safety of Epofolate (BMS-753493) in patients with advanced cancers (in Phase 1 portion) and to determine whether Epofolate (BMS-753493) can shrink or slow the growth of the cancer in patients with advanced ovarian, renal or breast cancer (in Phase 2 portion).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Epofolate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Advanced cancer, excluding cancer in the blood
- Availability of 10 tumor tissue slides
Key exclusion criteria (6 listed)
- Known brain metastases
- Severe nerve damage
- Significant cardiovascular disease
- Inadequate blood counts
- Inadequate liver or kidney 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 |
|---|---|---|
| EpofolateAlso: BMS-753493Intravenous solution, intravenous, initially 3 patients will be treated and if there is a DLT then additional 3 patients will be treated in that dose level. 3-5 minute IV bolus on Days 1, 4, 8 and 11 of a 21-day cycle, until the disease progresses | Drug | 1 |
Primary outcome
To determine the Maximum Tolerated Dose, the Dose Limiting Toxicity and the recommended dose of Epofolate (BMS-753493)
Time frame: at the end of the study
1 secondary outcome
To evaluate the safety and exposure levels of Epofolate (BMS-753493) in the body and the anticancer activity of Epofolate (BMS-753493)
Time frame: every 21 days
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 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Epofolate in people with Advanced Solid Tumors, run by Bristol-Myers Squibb at 4 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 2 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, Netherlands. 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 the Maximum Tolerated Dose, the Dose Limiting Toxicity and the recommended dose of Epofolate (BMS-753493) (time frame: at the end of the study). 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.