Neoplasm MalignantPhase 1NCT01836705
Effect of SAR302503 on ECG Activity in Patients With Solid Tumors
A Phase 1 study testing SAR302503 (TG101348) and Panolosetron in people with Neoplasm Malignant, run by Bristol-Myers Squibb at 10 sites in 2 countries.
Trial summary
Primary Objective: To assess the effect of SAR302503 (500 mg) administered as 14-day repeated doses on the QTcF interval compared to 1-day placebo in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm Malignant
- What is being tested?
- SAR302503 (TG101348) and Panolosetron
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 10 sitesin 2 countries
- Study dates
- May 2013to May 2014
- 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
Who cannot join
- Prior history of torsades de pointe, or congenital long QT syndrome.
- Conditions with screening ECG in which repolarization is difficult to interpret, or showing significant abnormalities. This includes, but is not limited to: High degree atrioventricular (AV) block, pacemaker, atrial fibrillation or flutter
- Screening ECG with QTc B or QTc F ≥480 msec (within 8 days of Day-1)
- Significant hypokalemia at screening (K+ <3.5 mmol/L) (within 8 days of Day-1)
- Significant hypomagnesemia at screening and inclusion (Mg++ <0.7 mmol/L) (within 8 days of Day -1)
- Patient receives (and cannot discontinue), or is scheduled to receive, a concomitant treatment known to carry a risk of both QT prolongation and torsade de pointe for 2 weeks before Day 1 and for the duration of Segment 1
Show all 34Show fewer
- Absence of completion of all prior chemotherapy, biological therapy, hormonal therapy, targeted non-cytotoxic therapy ≥3 weeks; and radiotherapy ≥2 weeks prior to inclusion.
- Patients with uncontrolled brain metastases or primary brain tumor. Patients with brain metastasis are considered eligible if the patient has not received radiation therapy for brain metastasis within 2 weeks of enrollment and has been on a stable dose of steroids for ≥ 2 weeks.
- Participation in any study of an investigational agent (drug, biologic, device) within 30 days prior to initiation of study drug, unless during non-treatment phase.
- Anticipation of need for a major surgical procedure or radiation therapy during the study treatment.
- Concurrent treatment in another clinical trial or with any other cancer therapy including chemotherapy, biological therapy, hormonal therapy, radiotherapy, chemoembolization, cryotherapy, targeted non-cytotoxic therapy or patients planning to receive these treatments during the study.
- Inadequate organ function as defined by:
- Absolute neutrophil count (ANC) <1.5 X 10^9/L
- Platelet count <100 X 10^9/L
- Hemoglobin: <9 g/dL
- Serum creatinine >1.5 x the upper limit of normal (ULN)
- Serum amylase or lipase >1.5 x ULN
- Total bilirubin >1.5 x ULN
- Aspartate aminotransferase or alanine aminotransferase ≥2.5 x ULN
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) >2 at study entry.
- Uncontrolled congestive heart failure (New York Heart Association Classification 3 or 4), angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism within 3 months prior to initiation of study drug.
- Ongoing or recent history (within 3 months of Day 1 Segment 1) of clinically significant dysrrhythmia.
- Patients taking a beta blocker within 7 days to Day 1 Segment 1 and during Segment 1
- Other concurrent serious illness or medical condition, including active infection or HIV disease.
- Patients with known active (acute or chronic) Hepatitis A, B, C, and hepatitis B and or C carriers. Prior history of chronic liver disease.
- Patients with 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.
- Any severe acute or chronic medical, neurological, or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, may interfere with the informed consent process and/or with compliance with the requirements of the study, or may interfere with interpretation of study results and, in the Investigator's opinion, would make the patient inappropriate for entry into this study.
- Contra-indications for palonosetron.
- Use of drugs or herbal agents known to be at least moderate inhibitors or inducers of CYP3A4, sensitive CYP3A4 substrate, or CYP3A4 substrate with narrow therapeutic index, within 2 weeks of Day 1 and during study.
- Concomitant treatment with H2-blockers is not allowed within 7 days prior to Day 1 Segment 1 and during entire study.
- Known hypersensitivity to any excipients in IMP formulations.
- Pregnant or lactating females
- Women of childbearing potential, unless using effective contraception (other than oral contraceptives) while on study drug. Men who partner with a woman of childbearing potential, unless they agree to use effective contraception while on study drug
- 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
10 sites in 2 countries.
10 sites in 2 countries
United States8 sites
Investigational Site Number 840007
Augusta, Georgia, 30912
Investigational Site Number 840004
Cincinnati, Ohio, 45267-0542
Investigational Site Number 840002
Detroit, Michigan, 48201
Investigational Site Number 840003
Los Angeles, California, 90048
Investigational Site Number 840005
Philadelphia, Pennsylvania, 19111
Investigational Site Number 840006
San Antonio, Texas, 78229
Investigational Site Number 840008
San Antonio, Texas, 78229
Investigational Site Number 840001
St Louis, Missouri, 63110
Belgium2 sites
Investigational Site Number 056001
Brussels, 1200
Investigational Site Number 056002
Ghent, 9000
About this study
Official title: Effect of 14-day Repeated Oral Doses of SAR302503 on Ventricular Repolarization, Compared to 1-day Placebo in Adult Patients With Refractory Solid Tumors
Primary Objective:
- To assess the effect of SAR302503 (500 mg) administered as 14-day repeated doses on the QTcF interval compared to 1-day placebo in patients with advanced solid tumors.
Secondary Objectives:
- To assess the effect of SAR302503 administered as 14-day repeated doses on heart rate (HR), QT, QTcB, and QTcN, PR and QRS compared to placebo.
- To assess the clinical and laboratory safety of SAR302503
- To document the plasma concentrations of SAR302503 at the time of ECG investigation.
- To explore the Pharmacokinetic/Pharmacodynamic relationship between SAR302503 concentration and QTcF
- To explore antitumor activity
Read the detailed description
Total 7-10 weeks if not progressing to Segment 2. Segment 2 will be additional in 28-day cycles.
- Conditions
- Neoplasm Malignant
- Being tested
- SAR302503 (TG101348), Placebo SAR302503, Panolosetron
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAR302503 (TG101348)Drug
Pharmaceutical form:capsule
Route of administration: oral
Placebo SAR302503Drug
Pharmaceutical form:capsule
Route of administration: oral
PanolosetronDrug
Also called Aloxi®
Pharmaceutical form:solution
Route of administration: intravenous
| Study group | Role | What they receive |
|---|---|---|
| Single-sequence | Experimental | SAR302503 Placebo (1 day)-SAR302503 (500 mg, oral, qd, 14 days) Receives: Drug: SAR302503 (TG101348); Drug: Placebo SAR302503; Drug: Panolosetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
QTc Friderica (QTcF) parameter
Measured: 16 days
Secondary outcomes (9)
Electrocardiographic parameters (Heart Rate)
Measured: 16 days
Electrocardiographic parameters (QT)
Measured: 16 days
Electrocardiographic parameters (QTcBazett)
Measured: 16 days
Electrocardiographic parameters (QTcN)
Measured: 16 days
Electrocardiographic parameters (PR interval)
Measured: 16 days
Electrocardiographic parameters (QRS interval)
Measured: 16 days
Anti-tumor activity
Measured: 16 or more days
Number of participants with Adverse Events
Measured: 16 or more days
Pharmacokinetic parameter: Cmax, AUC0-24, Tmax, Tmax, Ctrough
Measured: 16 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2013 (estimated)
- Study startMay 2013
- Primary completionNov 2013
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neoplasm MalignantStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 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
- NCT01836705
- Sponsor's protocol ID
- TES13519
- Other IDs
- 2012-005642-38, U1111-1115-7323
- Status last verified
- Jun 2014
- First submitted
- 17 Apr 2013
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Ogasawara K, Xu C, Yin J, Darpo B, Carayannopoulos L, Xue H, Palmisano M, Krishna G. Evaluation of the Potential for QTc Prolongation With Repeated Oral Doses of Fedratinib in Patients With Advanced Solid Tumors. Clin Pharmacol Drug Dev. 2021 Apr;10(4):366-375. doi: 10.1002/cpdd.850. Epub 2020 Jul 16.
PubMed 32673446
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
- Effect of 14-day Repeated Oral Doses of SAR302503 on Ventricular Repolarization, Compared to 1-day Placebo in Adult Patients With Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT01836705
- Acronym / sponsor ID
- TES13519
- Conditions
- Neoplasm Malignant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 22 Apr 2013 (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 SAR302503 (500 mg) administered as 14-day repeated doses on the QTcF interval compared to 1-day placebo in patients with advanced solid tumors.
Secondary Objectives:
- To assess the effect of SAR302503 administered as 14-day repeated doses on heart rate (HR), QT, QTcB, and QTcN, PR and QRS compared to placebo.
- To assess the clinical and laboratory safety of SAR302503
- To document the plasma concentrations of SAR302503 at the time of ECG investigation.
- To explore the Pharmacokinetic/Pharmacodynamic relationship between SAR302503 concentration and QTcF
- To explore antitumor activity
Detailed description
Total 7-10 weeks if not progressing to Segment 2. Segment 2 will be additional in 28-day cycles.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-sequence | Experimental | Drug: SAR302503 (TG101348), Drug: Placebo SAR302503, Drug: PanolosetronSAR302503 Placebo (1 day)-SAR302503 (500 mg, oral, qd, 14 days) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Histologically or cytologically confirmed advanced solid malignancy that is metastatic or unresectable, and for which standard curative measures do not exist
Key exclusion criteria (34 listed)
- Prior history of torsades de pointe, or congenital long QT syndrome.
- Conditions with screening ECG in which repolarization is difficult to interpret, or showing significant abnormalities. This includes, but is not limited to: High degree atrioventricular (AV) block, pacemaker, atrial fibrillation or flutter
- Screening ECG with QTc B or QTc F ≥480 msec (within 8 days of Day-1)
- Significant hypokalemia at screening (K+ <3.5 mmol/L) (within 8 days of Day-1)
- Significant hypomagnesemia at screening and inclusion (Mg++ <0.7 mmol/L) (within 8 days of Day -1)
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 |
|---|---|---|
| SAR302503 (TG101348)Pharmaceutical form:capsule Route of administration: oral | Drug | Single-sequence |
| Placebo SAR302503Pharmaceutical form:capsule Route of administration: oral | Drug | Single-sequence |
| PanolosetronAlso: Aloxi®Pharmaceutical form:solution Route of administration: intravenous | Drug | Single-sequence |
Primary outcome
QTc Friderica (QTcF) parameter
Time frame: 16 days
9 secondary outcomes
Electrocardiographic parameters (Heart Rate)
Time frame: 16 days
Electrocardiographic parameters (QT)
Time frame: 16 days
Electrocardiographic parameters (QTcBazett)
Time frame: 16 days
Electrocardiographic parameters (QTcN)
Time frame: 16 days
Electrocardiographic parameters (PR interval)
Time frame: 16 days
Electrocardiographic parameters (QRS interval)
Time frame: 16 days
Anti-tumor activity
Time frame: 16 or more days
Number of participants with Adverse Events
Time frame: 16 or more days
Pharmacokinetic parameter: Cmax, AUC0-24, Tmax, Tmax, Ctrough
Time frame: 16 days
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.
- Derived from this study: PubMed 32673446Ogasawara K, Xu C, Yin J, Darpo B, Carayannopoulos L, Xue H, Palmisano M, Krishna G. Evaluation of the Potential for QTc Prolongation With Repeated Oral Doses of Fedratinib in Patients With Advanced Solid Tumors. Clin Pharmacol Drug Dev. 2021 Apr;10(4):366-375. doi: 10.1002/cpdd.850. Epub 2020 Jul 16.
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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
10 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 SAR302503 (TG101348) and Panolosetron in people with Neoplasm Malignant, run by Bristol-Myers Squibb at 10 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 1 inclusion and 34 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 10 sites in United States, Belgium. 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?
QTc Friderica (QTcF) parameter (time frame: 16 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01836705, which also lists 1 linked publication.
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.