Solid TumorPhase 1NCT01585623
Drug Interaction Study of SAR302503 in Patients With Solid Tumor
A Phase 1 study testing SAR302503, omeprazol and metoprolol in people with Solid Tumor, run by Bristol-Myers Squibb at 3 sites in United States.
Trial summary
Primary Objective: To assess the effect of 15-day repeated oral doses of 500 mg SAR302503 on the cytochrome P450 activity using a CYP probe cocktail (2C19, 2D6 and 3A4). To document pharmacokinetics of SAR302503 after repeated 500 mg oral daily doses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- SAR302503, omeprazol and metoprolol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2012to Mar 2013
- 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
- Histologically or cytologically confirmed advanced solid malignancy that is metastatic or unresectable, and for which standard curative measures do not exist
- Signed informed consent
Who cannot join
- Less than 18 years of age.
- Limited physical functioning (as evaluated by the Eastern Cooperative Oncology Group (ECOG) scale)
- Inability to follow study requirements and schedule
- Treatment of cancer within 3 weeks of study, concurrent treatment in another clinical trial or with any other anti-cancer therapy
- Serious medical illness at same time of study and/or significantly abnormal lab reports
- Lack of pregnancy contraception (women of childbearing potential), pregnancy, or breast feeding.
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- Men who partner with a woman of childbearing potential, unless they agree to use effective contraception while on study drug
- Continued toxic effects of prior chemotherapy
- Evidence of other concurrent active malignancy
- Other concurrent serious illness or medical condition
- Cardiac abnormalities include bradycardia, AV block or other conduction defect on ECG, and patients taking a beta blocker.
- Patients with Insulin-Dependent Diabetes Mellitus.
- Patients with known active (acute or chronic) hepatitis A, B, C, and hepatitis B and C carries. Prior history of chronic liver disease (e.g., chronic alcoholic liver disease, autoimmune hepatitis, sclerosing cholangitis, primary biliary cirrhosis, hemachromatosis, non-alcoholic steatohepatitis [NASH]).
- Inadequate organ function
- History of partial or total gastrectomy, or, if in the opinion of the investigator, have any other disorder that would inhibit absorption of oral medications.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Investigational Site Number 840004
Augusta, Georgia, 30912
Investigational Site Number 840001
Detroit, Michigan, 48201
Investigational Site Number 840002
Philadelphia, Pennsylvania, 19111
About this study
Official title: An Open-label, Two-treatment Crossover Pharmacokinetic Interaction Study of Repeated Doses of SAR302503 on Pharmacokinetics of a Single Dose Cocktail of Omeprazole, Metoprolol, and Midazolam Used as Probe Substrates for CYP2C19, CYP2D6 and CYP3A4 Activities, Respectively in Adult Patients With Refractory Solid Tumors
Primary Objective:
- To assess the effect of 15-day repeated oral doses of 500 mg SAR302503 on the cytochrome P450 activity using a CYP probe cocktail (2C19, 2D6 and 3A4).
- To document pharmacokinetics of SAR302503 after repeated 500 mg oral daily doses.
Secondary Objectives:
- To assess the safety profile of 15-day repeated oral doses of 500 mg SAR302503 in Segment 1
- To characterize the safety and tolerability of 28-day consecutive doses of 500 mg SAR302503 in Segment 2
- To determine antitumor activity in Segment 2
Read the detailed description
The duration of the study for an individual patient will include a period to assess eligibility (screening period 21 days), followed by a treatment period of at least 15 days of study treatment, and an end-of-treatment visit at least 30 days following the last administration of study drug. However, treatment may continue if patients are receiving benefit and do not have unacceptable toxicity or meet study withdrawal criteria.
- Conditions
- Solid Tumor
- Being tested
- SAR302503, omeprazol, metoprolol, midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAR302503Drug
Pharmaceutical form:capsule
Route of administration: oral
omeprazolDrug
Pharmaceutical form:capsule
Route of administration: oral
metoprololDrug
Pharmaceutical form:tablet
Route of administration: oral
midazolamDrug
Pharmaceutical form:solution
Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| Segment 1 | Experimental | two single doses of omeprazol/metoprolol/midazolam on day-1 and day 15 without food, SAR302503 500 mg once daily without food for 15 days Receives: Drug: SAR302503; Drug: omeprazol; Drug: metoprolol; Drug: midazolam |
| Segment 2 | Experimental | SAR302503 500 mg once daily without food in 28-day per cycle Receives: Drug: SAR302503 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Omerprazole/metoprolol/midazolam - Pharmacokinetic parameter: AUC, AUClast
Measured: predose and up to 24 hours post dose on Days -1, 1, 15 and 16
Secondary outcomes (4)
Omerprazole/metoprolol/midazolam - Pharmacokinetic parameter : Cmax, Tmax, and t1/2z
Measured: predose and up to 24 hours post dose on Days -1, 1, 15 and 16
SAR302503 - Pharmacokinetic parameter : Cmax, Tmax, Ctrough and AUC0-24
Measured: Day-1 to Day 16
Clinical and laboratory events graded by the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) v4.03 (Segment 1 and 2)
Measured: up to maximum 2 years
Objective response ratio (Complete response (CR) and partial response (PR)) (Segment 2)
Measured: up to 2 cycles ( i.e. 10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2012 (estimated)
- Study startJun 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01585623
- Sponsor's protocol ID
- INT12497
- Other IDs
- U1111-1125-8930
- Status last verified
- Mar 2013
- First submitted
- 13 Apr 2012
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Two-treatment Crossover Pharmacokinetic Interaction Study of Repeated Doses of SAR302503 on Pharmacokinetics of a Single Dose Cocktail of Omeprazole, Metoprolol, and Midazolam Used as Probe Substrates for CYP2C19, CYP2D6 and CYP3A4 Activities, Respectively in Adult Patients With Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT01585623
- Acronym / sponsor ID
- INT12497
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 26 Apr 2012 (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.
Primary Objective:
- To assess the effect of 15-day repeated oral doses of 500 mg SAR302503 on the cytochrome P450 activity using a CYP probe cocktail (2C19, 2D6 and 3A4).
- To document pharmacokinetics of SAR302503 after repeated 500 mg oral daily doses.
Secondary Objectives:
- To assess the safety profile of 15-day repeated oral doses of 500 mg SAR302503 in Segment 1
- To characterize the safety and tolerability of 28-day consecutive doses of 500 mg SAR302503 in Segment 2
- To determine antitumor activity in Segment 2
Detailed description
The duration of the study for an individual patient will include a period to assess eligibility (screening period 21 days), followed by a treatment period of at least 15 days of study treatment, and an end-of-treatment visit at least 30 days following the last administration of study drug. However, treatment may continue if patients are receiving benefit and do not have unacceptable toxicity or meet study withdrawal criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Segment 1 | Experimental | Drug: SAR302503, Drug: omeprazol, Drug: metoprolol, Drug: midazolamtwo single doses of omeprazol/metoprolol/midazolam on day-1 and day 15 without food, SAR302503 500 mg once daily without food for 15 days |
| Segment 2 | Experimental | Drug: SAR302503SAR302503 500 mg once daily without food in 28-day per cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Histologically or cytologically confirmed advanced solid malignancy that is metastatic or unresectable, and for which standard curative measures do not exist
- Signed informed consent
Key exclusion criteria (16 listed)
- Less than 18 years of age.
- Limited physical functioning (as evaluated by the Eastern Cooperative Oncology Group (ECOG) scale)
- Inability to follow study requirements and schedule
- Treatment of cancer within 3 weeks of study, concurrent treatment in another clinical trial or with any other anti-cancer therapy
- Serious medical illness at same time of study and/or significantly abnormal lab reports
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 |
|---|---|---|
| SAR302503Pharmaceutical form:capsule Route of administration: oral | Drug | Segment 1, Segment 2 |
| omeprazolPharmaceutical form:capsule Route of administration: oral | Drug | Segment 1 |
| metoprololPharmaceutical form:tablet Route of administration: oral | Drug | Segment 1 |
| midazolamPharmaceutical form:solution Route of administration: oral | Drug | Segment 1 |
Primary outcome
Omerprazole/metoprolol/midazolam - Pharmacokinetic parameter: AUC, AUClast
Time frame: predose and up to 24 hours post dose on Days -1, 1, 15 and 16
4 secondary outcomes
Omerprazole/metoprolol/midazolam - Pharmacokinetic parameter : Cmax, Tmax, and t1/2z
Time frame: predose and up to 24 hours post dose on Days -1, 1, 15 and 16
SAR302503 - Pharmacokinetic parameter : Cmax, Tmax, Ctrough and AUC0-24
Time frame: Day-1 to Day 16
Clinical and laboratory events graded by the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) v4.03 (Segment 1 and 2)
Time frame: up to maximum 2 years
Objective response ratio (Complete response (CR) and partial response (PR)) (Segment 2)
Time frame: up to 2 cycles ( i.e. 10 weeks)
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 5 Mar 2025.
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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.
Clinical Sciences & Operations study director
Sanofi
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SAR302503, omeprazol and metoprolol in people with Solid Tumor, run by Bristol-Myers Squibb at 3 sites in United States.
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 16 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 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Omerprazole/metoprolol/midazolam - Pharmacokinetic parameter: AUC, AUClast (time frame: predose and up to 24 hours post dose on Days -1, 1, 15 and 16). 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 5 Mar 2025.