Neoplasm MalignantPhase 1NCT01943838
A Study of the Safety and Pharmacokinetics of SAR245408 Tablets in Patients With Solid Tumors or Lymphoma
A Phase 1 study testing SAR245408 in people with Neoplasm Malignant, run by Sanofi at 1 site in Belgium.
Trial summary
Primary Objective: To assess the safety, tolerability and plasma pharmacokinetics (PK) of SAR245408 given once daily as a tablet formulation of polymorph E in subjects with solid tumors or lymphoma. 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?
- SAR245408
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2013to Feb 2015
- 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
- Solid tumor that is metastatic or unresectable, or relapsed or refractory lymphoma (including chronic lymphocytic leukemia/small lymphocytic lymphoma), for which standard therapies are no longer effective or there are no therapies known to prolong survival or patient cannot tolerate or has contra-indication for a standard therapy and there is no alternative therapies.
- Male or female patient > or = 18 years old.
- Weight > or = 40 kg.
- Eastern Cooperative Oncology Group performance status < or = 1.
- Adequate white blood cells, platelets, and haemoglobin.
- Adequate liver and kidney functions.
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- Fasting plasma glucose < 8.9 mmol/L.
- Sexually active patients using adequate contraception.
- Women of child-bearing potential with negative pregnancy test.
Who cannot join
- Lymphoma involving the gastrointestinal tract.
- Prior treatment with cytotoxic chemotherapy (including investigational agents) or biologic agents (antibodies, immune modulators, and cytokines) within 4 weeks, or nitrosoureas or mitomycin C within 6 weeks, before the first dose of study drug.
- Prior treatment with a small-molecule kinase inhibitor (including investigational agents) within 2 weeks, or 5 half lives of the drug or active metabolites, whichever is longer, before the first dose of study drug.
- Any other investigational therapy within 4 weeks before the first dose of study drug.
- Intolerance to prior treatment with a PI3K inhibitor.
- Prior anticancer hormonal therapy within 2 weeks before the first dose of study drug.
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- Prior radiation therapy within 2 weeks before the first dose of study drug.
- Uncontrolled brain metastases or primary brain tumor.
- Hereditary or acquired immunodeficiency syndrome or human immunodeficiency virus (HIV) infection.
- Positive serologies for Hepatitis B surface antigen (HBsAg) or anti-Hepatitis C virus (anti-HCV) antibodies.
- Patient is pregnant or breastfeeding.
- History of gastrointestinal surgery, or presence of gastrointestinal abnormality or disease, that may affect the pharmacokinetics of 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
1 site in 1 country.
About this study
Official title: A Phase 1 Dose-escalation Study of the Safety and Pharmacokinetics of a Tablet Formulation of SAR245408 Polymorph E Administered Once Daily to Subjects With Solid Tumors or Lymphoma
Primary Objective:
- To assess the safety, tolerability and plasma pharmacokinetics (PK) of SAR245408 given once daily as a tablet formulation of polymorph E in subjects with solid tumors or lymphoma.
Read the detailed description
Screening: 1 to 28 days Study treatment period: two 28-day cycles (56 days) End-of-treatment visit: no later than 7 days after the last study drug administration Subjects not eligible for treatment continuation after Cycle 2 will be followed up for safety; a follow-up visit will be performed within 30 ± 3 days after the last study drug administration Subjects eligible for treatment continuation after Cycle 2 will be offered the opportunity to enroll in the treatment-extension study TED12414.
Total duration of study participation for each patient: 58 to 118 days.
- 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 polymorph E tablets | Experimental | Escalating doses of SAR245408 polymorph E tablets, once daily dosing with morning meal every day for two 28-days cycles Receives: Drug: SAR245408 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicities
Measured: Up to Day 28
Secondary outcomes (3)
Number of patients with treatment-emergent adverse events
Measured: From first dose of SAR245408 up to 30 days after the last dose
Maximum SAR245408 plasma concentration
Measured: Days 1, 2, 8, 15, 29 and 30
Area under the SAR245408 plasma concentration versus time curve
Measured: Days 1, 2, 8, 15, 29 and 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionFeb 2015
- Study completionFeb 2015
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
- 18 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
- NCT01943838
- Sponsor's protocol ID
- TED12863
- Other IDs
- 2012-003368-39, U1111-1132-9056
- Status last verified
- Apr 2016
- First submitted
- 12 Sep 2013
- Last updated
- 22 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose-escalation Study of the Safety and Pharmacokinetics of a Tablet Formulation of SAR245408 Polymorph E Administered Once Daily to Subjects With Solid Tumors or Lymphoma
- ClinicalTrials.gov ID
- NCT01943838
- Acronym / sponsor ID
- TED12863
- Conditions
- Neoplasm Malignant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 17 Sep 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 safety, tolerability and plasma pharmacokinetics (PK) of SAR245408 given once daily as a tablet formulation of polymorph E in subjects with solid tumors or lymphoma.
Detailed description
Screening: 1 to 28 days Study treatment period: two 28-day cycles (56 days) End-of-treatment visit: no later than 7 days after the last study drug administration Subjects not eligible for treatment continuation after Cycle 2 will be followed up for safety; a follow-up visit will be performed within 30 ± 3 days after the last study drug administration Subjects eligible for treatment continuation after Cycle 2 will be offered the opportunity to enroll in the treatment-extension study TED12414.
Total duration of study participation for each patient: 58 to 118 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SAR245408 polymorph E tablets | Experimental | Drug: SAR245408Escalating doses of SAR245408 polymorph E tablets, once daily dosing with morning meal every day for two 28-days cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Solid tumor that is metastatic or unresectable, or relapsed or refractory lymphoma (including chronic lymphocytic leukemia/small lymphocytic lymphoma), for which standard therapies are no longer effective or there are no therapies known to prolong survival or patient cannot tolerate or has contra-indication for a standard therapy and there is no alternative therapies.
- Male or female patient > or = 18 years old.
- Weight > or = 40 kg.
- Eastern Cooperative Oncology Group performance status < or = 1.
- Adequate white blood cells, platelets, and haemoglobin.
Key exclusion criteria (13 listed)
- Lymphoma involving the gastrointestinal tract.
- Prior treatment with cytotoxic chemotherapy (including investigational agents) or biologic agents (antibodies, immune modulators, and cytokines) within 4 weeks, or nitrosoureas or mitomycin C within 6 weeks, before the first dose of study drug.
- Prior treatment with a small-molecule kinase inhibitor (including investigational agents) within 2 weeks, or 5 half lives of the drug or active metabolites, whichever is longer, before the first dose of study drug.
- Any other investigational therapy within 4 weeks before the first dose of study drug.
- Intolerance to prior treatment with a PI3K inhibitor.
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 polymorph E tablets |
Primary outcome
Dose Limiting Toxicities
Time frame: Up to Day 28
3 secondary outcomes
Number of patients with treatment-emergent adverse events
Time frame: From first dose of SAR245408 up to 30 days after the last dose
Maximum SAR245408 plasma concentration
Time frame: Days 1, 2, 8, 15, 29 and 30
Area under the SAR245408 plasma concentration versus time curve
Time frame: Days 1, 2, 8, 15, 29 and 30
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 22 Apr 2016.
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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
1 site 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 1 site in Belgium.
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 9 inclusion and 13 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 22 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
Dose Limiting Toxicities (time frame: Up to Day 28). 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 22 Apr 2016.