Neoplasm MalignantPhase 1NCT01596270
A Study of the Safety and Pharmacokinetics of SAR245409 Tablets in Patients With Solid Tumors or Lymphoma
A Phase 1 study testing SAR245409 in people with Neoplasm Malignant, run by Sanofi at 3 sites in United States.
Trial summary
Primary Objective: To evaluate the safety and tolerability of SAR245409 tablets administered once or twice a day in patients with solid tumors or lymphoma. Secondary Objectives: To evaluate blood levels of SAR245409 after administration of SAR245409 tablets once or twice a day in patients with solid tumors or… 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?
- SAR245409
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2012to Oct 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
- 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.
- Male or female patient > or = 18 years old.
- Eastern Cooperative Oncology Group Performance Status < or = 1.
- Adequate white blood cells, platelets and haemoglobin.
- Adequate liver and kidney functions.
- Fasting plasma glucose < 160 mg/dL.
- No other malignancy.
- Women of childbearing potential using adequate contraception.
Who cannot join
- History of partial or full gastrectomy.
- Lymphoma involving the gastrointestinal tract.
- Uncontrolled brain metastases or a primary brain tumor.
- 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 treatment.
- 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 treatment.
- Any other investigational therapy within 4 weeks before the first dose of study treatment.
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- Prior anticancer hormonal therapy within 1 week before the first dose of study treatment.
- Prior radiation therapy within 2 weeks before the first dose of study treatment.
- Intolerance of prior treatment with a PI3K inhibitor.
- Hereditary or acquired immunodeficiency syndrome or HIV (human immunodeficiency virus) infection.
- Lymphoma patients with positive serologies for Hepatitis B surface antigen (HBsAg) or anti-Hepatitis C virus (anti-HCV) antibodies.
- Positive serologies for Hepatitis B surface antigen (HBsAg) or anti-Hepatitis C virus (anti-HCV) antibodies.
- Patient is pregnant or breastfeeding.
- 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 840003
Dallas, Texas, 75230
Investigational Site Number 840001
Detroit, Michigan, 48201
Investigational Site Number 840002
New Brunswick, New Jersey, 08903
About this study
Official title: A Phase 1 Dose-escalation Study of the Safety and Pharmacokinetics of a Tablet Formulation of SAR245409 Administered Daily to Patients With Solid Tumors or Lymphoma
Primary Objective:
- To evaluate the safety and tolerability of SAR245409 tablets administered once or twice a day in patients with solid tumors or lymphoma.
Read more
Secondary Objectives:
- To evaluate blood levels of SAR245409 after administration of SAR245409 tablets once or twice a day in patients with solid tumors or lymphoma.
- To evaluate the effect of food on blood levels of SAR245409 after administration of SAR245409 tablets in patients with solid tumors or lymphoma.
- To evaluate the effect of SAR245409 on the body after administration of SAR245409 tablets once or twice a day in patients with solid tumors or lymphoma.
- To obtain information on how SAR245409 administered once or twice a day to patients with solid tumors or lymphoma affect disease symptoms and study treatment side effects as reported by the patients on a questionnaire.
- To explore the antitumor activity of SAR245409 tablets administered once or twice a day to patients with solid tumors or lymphoma.
Read the detailed description
The total study duration per patient will be 58 to 128 days and will include a screening period (1 to 28 days), a food interaction investigation period (when applicable; 4 to 11 days), two 28-day treatment cycles (56 days), an end-of-treatment visit (within 7 days after the last SAR245409 administration) and a follow-up visit (within 30 ± 3 days after the last SAR245409 administration).
- Conditions
- Neoplasm Malignant
- Being tested
- SAR245409
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAR245409Drug
Pharmaceutical form: tablet Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| Once daily dosing | Experimental | escalating doses, once daily dosing every day, no eating for 2 hours prior and 1 hour after dose Receives: Drug: SAR245409 |
| Twice daily dosing | Experimental | escalating doses, twice daily dosing every day, no eating for 2 hours prior and 1 hour after dose Receives: Drug: SAR245409 |
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 (5)
Number of patients with treatment-emergent adverse events
Measured: From first dose of SAR245409 until 30 days after the last dose
Maximum SAR245409 plasma concentration
Measured: Cycle 1 Days 1, 2, 8, 15, and 28, and Cycle 2 Day 1
Area under the SAR245409 plasma concentration versus time curve
Measured: Cycle 1 Days 1, 2, 8, 15, and 28, and Cycle 2 Day 1
Ratio of maximum SAR245409 plasma concentration between fed and fasted dosing
Measured: Days 1, 2, 3, and 4 of the food interaction period
Ratio of area under the SAR245409 plasma concentration versus time curve between fed and fasted dosing
Measured: Days 1, 2, 3, and 4 of the food interaction period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2012 (estimated)
- Study startJun 2012
- Primary completionOct 2014
- Study completionOct 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 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
- NCT01596270
- Sponsor's protocol ID
- TED12471
- Other IDs
- U1111-1123-1488
- Status last verified
- Oct 2014
- First submitted
- 9 May 2012
- Last updated
- 28 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. 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 SAR245409 Administered Daily to Patients With Solid Tumors or Lymphoma
- ClinicalTrials.gov ID
- NCT01596270
- Acronym / sponsor ID
- TED12471
- Conditions
- Neoplasm Malignant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 10 May 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 evaluate the safety and tolerability of SAR245409 tablets administered once or twice a day in patients with solid tumors or lymphoma.
Secondary Objectives:
- To evaluate blood levels of SAR245409 after administration of SAR245409 tablets once or twice a day in patients with solid tumors or lymphoma.
- To evaluate the effect of food on blood levels of SAR245409 after administration of SAR245409 tablets in patients with solid tumors or lymphoma.
- To evaluate the effect of SAR245409 on the body after administration of SAR245409 tablets once or twice a day in patients with solid tumors or lymphoma.
- To obtain information on how SAR245409 administered once or twice a day to patients with solid tumors or lymphoma affect disease symptoms and study treatment side effects as reported by the patients on a questionnaire.
- To explore the antitumor activity of SAR245409 tablets administered once or twice a day to patients with solid tumors or lymphoma.
Detailed description
The total study duration per patient will be 58 to 128 days and will include a screening period (1 to 28 days), a food interaction investigation period (when applicable; 4 to 11 days), two 28-day treatment cycles (56 days), an end-of-treatment visit (within 7 days after the last SAR245409 administration) and a follow-up visit (within 30 ± 3 days after the last SAR245409 administration).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Once daily dosing | Experimental | Drug: SAR245409escalating doses, once daily dosing every day, no eating for 2 hours prior and 1 hour after dose |
| Twice daily dosing | Experimental | Drug: SAR245409escalating doses, twice daily dosing every day, no eating for 2 hours prior and 1 hour after dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 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.
- Male or female patient > or = 18 years old.
- Eastern Cooperative Oncology Group Performance Status < or = 1.
- Adequate white blood cells, platelets and haemoglobin.
- Adequate liver and kidney functions.
Key exclusion criteria (14 listed)
- History of partial or full gastrectomy.
- Lymphoma involving the gastrointestinal tract.
- Uncontrolled brain metastases or a primary brain tumor.
- 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 treatment.
- 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 treatment.
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 |
|---|---|---|
| SAR245409Pharmaceutical form: tablet Route of administration: oral | Drug | Once daily dosing, Twice daily dosing |
Primary outcome
Dose Limiting Toxicities
Time frame: Up to Day 28
5 secondary outcomes
Number of patients with treatment-emergent adverse events
Time frame: From first dose of SAR245409 until 30 days after the last dose
Maximum SAR245409 plasma concentration
Time frame: Cycle 1 Days 1, 2, 8, 15, and 28, and Cycle 2 Day 1
Area under the SAR245409 plasma concentration versus time curve
Time frame: Cycle 1 Days 1, 2, 8, 15, and 28, and Cycle 2 Day 1
Ratio of maximum SAR245409 plasma concentration between fed and fasted dosing
Time frame: Days 1, 2, 3, and 4 of the food interaction period
Ratio of area under the SAR245409 plasma concentration versus time curve between fed and fasted dosing
Time frame: Days 1, 2, 3, and 4 of the food interaction period
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 28 Oct 2020.
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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 SAR245409 in people with Neoplasm Malignant, run by Sanofi 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 8 inclusion and 14 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 28 Oct 2020. 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?
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 28 Oct 2020.