Neoplasm MalignantPhase 1NCT01392924
Safety and Pharmacokinetics of SAR245408 Daily Oral in Patients With Solid Tumors
A Phase 1 study testing SAR245408 in people with Neoplasm Malignant, run by Sanofi at 2 sites in Japan.
Trial summary
Primary Objective: To confirm safety and tolerability of global recommended phase three dose (RPTD) of SAR245408 tablets when administered on continuous once daily dosing (CDD) in patients with solid tumors. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Neoplasm Malignant
- What is being tested?
- SAR245408
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesJapan
- Study dates
- Aug 2011to Nov 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed solid tumor that is metastatic or unresectable, and for which standard curative or palliative measures do not exist or are no longer effective, and there are no known therapies to prolong survival.
- Before any study-specific procedure, the appropriate Institutional Review Board (IRB) approved written informed consent must be obtained. Second informed consent must be obtained before the patient starts the Treatment Extension Period (Cycle 2 and after).
- Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
Who cannot join
- < 20 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status > 2.
- Incapable of understanding or complying with the protocol or has not signed the informed consent document.
- Unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.
- Inadequate organ or bone marrow function.
- Prothrombin time (PT)/International Normalized Ratio (INR) and/or partial thromboplastin time (PTT) test results at screening that are above 1.3 × the laboratory upper limit of normal (ULN).
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- Baseline corrected QT interval (QTc) > 460 ms.
- Sexually active (males and females) who do not agree to use medically acceptable methods of contraception during the course of the study and for 3 months following discontinuation of study drug. Female patients of childbearing potential must have a negative pregnancy test at screening.
- Pregnant or breastfeeding.
- Has not tolerated previous treatment with other phosphatidylinositol 3-kinase (PI3K) inhibitor, or has been treated with SAR245408.
- Not recovered from all previous therapies (i.e. radiation, surgery, or medication)
- Currently receiving anticoagulation with therapeutic doses of warfarin (low-dose warfarin ≤ 1mg/day is permitted).
- Primary brain tumor or 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 or more weeks.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (including cytomegalovirus, Epstein-Barr virus, toxoplasmosis, and hepatitis B and C), symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
- Known to be positive for the human immunodeficiency virus (HIV)
- Psychiatric illness/social situation(s) that would limit compliance with study requirements.
- Allergy or hypersensitivity to components of the SAR245408 formulation.
- Withdraws consent during the screening (starting from signed informed consent form (ICF))
- Patient who is judged by the investigator as not suitable for participating in the study
- 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
2 sites in 1 country.
Japan2 sites
Investigational Site Number 392002
Kobe
Investigational Site Number 392001
Nagoya
About this study
Official title: An Open Label, Dose Escalation Study Evaluating the Safety and Pharmacokinetics of SAR245408 Administered Orally Daily in Patients With Solid Tumors
Primary Objective:
- To confirm safety and tolerability of global recommended phase three dose (RPTD) of SAR245408 tablets when administered on continuous once daily dosing (CDD) in patients with solid tumors.
Secondary Objectives:
- To evaluate the plasma pharmacokinetics (PK) of daily oral administration of SAR245408 in CDD treatment schedule in patients with solid tumors.
- To gather preliminary efficacy data after repeated administration of SAR245408 in patients with solid tumors.
Read the detailed description
The duration of the study for 1 patient will include a period for screening up to 28 days, the study treatment period, followed by a 28-day follow-up after the last study drug administration.
- Conditions
- Neoplasm Malignant
- Being tested
- SAR245408
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAR245408Drug
Pharmaceutical form: tablet Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| SAR245408 | Experimental | single cohort: SAR245408 administered once daily Receives: Drug: SAR245408 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity in cycle 1
Measured: 4 weeks
Secondary outcomes (9)
Number of treatment emergent adverse events
Measured: 28 days after the last dosing
Number of serious adverse events
Measured: 28 days after the last dosing
Number of abnormality of laboratory test as graded by National Cancer Institute-Common Toxicity Criteria
Measured: 28 days after the last dosing
Pharmacokinetics (Cmax) of SAR245408
Cycles 1 and 2, and every 4th cycle after Cycle 4
Measured: an expected average of 3 months
Pharmacokinetics (tmax) of SAR245408
Cycles 1 and 2, and every 4th cycle after Cycle 4
Measured: an expected average of 3 months
Pharmacokinetics (AUC) of SAR245408
Cycles 1 and 2, and every 4th cycle after Cycle 4
Measured: an expected average of 3 months
Pharmacokinetics (accumulation ratio) of SAR245408
Cycles 1 and 2, and every 4th cycle after Cycle 4
Measured: an expected average of 3 months
Pharmacokinetics (Ctrough) of SAR245408
Cycles 1 and 2, and every 4th cycle after Cycle 4
Measured: an expected average of 3 months
Objective tumor response as defined by RECIST (response evaluation criteria in solid tumors)
Measured: At 8 weeks and every 2 months thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2011 (estimated)
- Study startAug 2011
- Primary completionFeb 2012
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasm MalignantStudies of the same condition, open and under way.
- More trials run by SanofiThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01392924
- Sponsor's protocol ID
- TED11883
- Other IDs
- U1111-1118-9727
- Status last verified
- Dec 2014
- First submitted
- 5 Jul 2011
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Dose Escalation Study Evaluating the Safety and Pharmacokinetics of SAR245408 Administered Orally Daily in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT01392924
- Acronym / sponsor ID
- TED11883
- Conditions
- Neoplasm Malignant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 13 Jul 2011 (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 confirm safety and tolerability of global recommended phase three dose (RPTD) of SAR245408 tablets when administered on continuous once daily dosing (CDD) in patients with solid tumors.
Secondary Objectives:
- To evaluate the plasma pharmacokinetics (PK) of daily oral administration of SAR245408 in CDD treatment schedule in patients with solid tumors.
- To gather preliminary efficacy data after repeated administration of SAR245408 in patients with solid tumors.
Detailed description
The duration of the study for 1 patient will include a period for screening up to 28 days, the study treatment period, followed by a 28-day follow-up after the last study drug administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SAR245408 | Experimental | Drug: SAR245408single cohort: SAR245408 administered once daily |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically or cytologically confirmed solid tumor that is metastatic or unresectable, and for which standard curative or palliative measures do not exist or are no longer effective, and there are no known therapies to prolong survival.
- Before any study-specific procedure, the appropriate Institutional Review Board (IRB) approved written informed consent must be obtained. Second informed consent must be obtained before the patient starts the Treatment Extension Period (Cycle 2 and after).
- Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
Key exclusion criteria (20 listed)
- < 20 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status > 2.
- Incapable of understanding or complying with the protocol or has not signed the informed consent document.
- Unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.
- Inadequate organ or bone marrow 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 |
|---|---|---|
| SAR245408Pharmaceutical form: tablet Route of administration: oral | Drug | SAR245408 |
Primary outcome
Dose limiting toxicity in cycle 1
Time frame: 4 weeks
9 secondary outcomes
Number of treatment emergent adverse events
Time frame: 28 days after the last dosing
Number of serious adverse events
Time frame: 28 days after the last dosing
Number of abnormality of laboratory test as graded by National Cancer Institute-Common Toxicity Criteria
Time frame: 28 days after the last dosing
Pharmacokinetics (Cmax) of SAR245408
Time frame: an expected average of 3 months
Pharmacokinetics (tmax) of SAR245408
Time frame: an expected average of 3 months
Pharmacokinetics (AUC) of SAR245408
Time frame: an expected average of 3 months
Pharmacokinetics (accumulation ratio) of SAR245408
Time frame: an expected average of 3 months
Pharmacokinetics (Ctrough) of SAR245408
Time frame: an expected average of 3 months
Objective tumor response as defined by RECIST (response evaluation criteria in solid tumors)
Time frame: At 8 weeks and every 2 months thereafter
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 3 Dec 2014.
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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
2 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 SAR245408 in people with Neoplasm Malignant, run by Sanofi at 2 sites in Japan.
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 20 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 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. 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?
Dose limiting toxicity in cycle 1 (time frame: 4 weeks). 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 3 Dec 2014.