Neoplasm MalignantPhase 1NCT01156870
First in Man Study of SAR566658 Administered in Patients With CA6-Positive and Refractory Solid Tumor
A Phase 1 study testing SAR566658 in people with Neoplasm Malignant, run by Sanofi at 5 sites in 3 countries.
Trial summary
Primary Objective: To determine the maximum tolerated dose (MTD) of SAR566658 Secondary Objectives: To characterize the safety profile of SAR566658 To evaluate the pharmacokinetic profile of SAR566658 To assess the potential immunogenicity of SAR566658 To assess preliminary antitumor activity To assess the effect of… 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?
- SAR566658
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 8 Sep 2010to 7 Apr 2017
- 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
- Diagnosis of CA6-positive solid tumors as moderate to intense membrane staining of ≥15% of tumor cells for which no standard therapy is available.
Who cannot join
- Eastem Cooperative Oncology Group performance status ≥2.
- Any serious active disease or co-morbid condition, which, in the opinion of the Investigator, may interfere with the safety or the compliance with the study.
- Poor bone marrow reserve.
- Poor liver and renal function.
- Pregnant or breast-feeding woman.
- No use of effective birth control methods, when applicable.
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- No resolution of all specific toxicities (excluding alopecia) related to any prior anti-cancer therapy to Grade ≤1 according to the National Cancer Institute - Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 4.03 grade scaling.
- Wash out period of less than 3 weeks from previous antitumor therapy or any investigational treatment, (and less than 6 weeks in case of prior nitroso-urea and or mitomycin C treatment). Patients will be eligible if hormonotherapy (ie, for breast tumors) is discontinued before first Investigational product administration.
- Wash out period of less than 1 week from last palliative dose of radiotherapy.
- Patients with respiratory insufficiency defined by a decrease more than 50% compared to theoretical baseline pulmonary volumes and theoretical baseline Diffusing capacity of the Lung for Carbon monoxyde.
- Any lung radiotherapy in patient's cancer history.
- Patients with previous history or active interstitial lung disease or pulmonary fibrosis.
- Patients with abnormal cardiac function defined by a Left Ventricular Ejection Fraction <50%.
- Patients with previous history of acute cardiac failure.
- Patients with previous history and/or unresolved corneal disorders.
- Known intolerance to infused protein products or maytansinoids.
- Patients treated with strong CYP3A inhibitors within 2 weeks prior study drug administration.
- For patients to be treated in the midazolam cohort:
- Any treatment known to induce CYP3A isoenzymes or to inhibit CYP3A4 activities not allowed within 2 weeks before midazolam administration and up to the end of pharmacokinetic sampling following the last midazolam administration.
- Any contra-indications to midazolam, according to the applicable labeling.
- Patients older than 60 years.
- 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
5 sites in 3 countries.
5 sites in 3 countries
United States2 sites
Investigational Site Number 840002
Cincinnati, Ohio, 45267-0542
Investigational Site Number 840001
San Antonio, Texas, 78229
Spain2 sites
Investigational Site Number 724002
Madrid, 28040
Investigational Site Number 724001
Madrid, 28050
About this study
Official title: Dose Escalation, Safety and Pharmacokinetic, First in Man Study, of SAR566658 Administered as a Single Agent by Intravenous Infusion in Adult Patients With CA6-Positive and Refractory Solid Tumors
Primary Objective:
To determine the maximum tolerated dose (MTD) of SAR566658
Secondary Objectives:
- To characterize the safety profile of SAR566658
- To evaluate the pharmacokinetic profile of SAR566658
- To assess the potential immunogenicity of SAR566658
- To assess preliminary antitumor activity
- To assess the effect of SAR566658 at recommended dose on CYP3A enzyme activity using midazolam
- To assess safety in the alternative schedules of SAR566658 administration
Read the detailed description
The duration of the study for one patient in the dose escalation phase of the study will include a screening period of up to 3 weeks, a 3-week treatment cycle(s) and a 2-week treatment cycle(s). The patients may continue treatment until disease progression, unacceptable toxicity, or willingness to stop, followed by a minimum of 30-day follow-up. If a patient treated in dose escalation part or in an expansion cohorts, continues to benefit from the treatment at the time of Clinical Study Report, the patient can continue study treatment and will continue to undergo all assessments as per the study flowchart. Such patients will be followed at least until 30 days after the last IMP administration.
- Conditions
- Neoplasm Malignant
- Being tested
- SAR566658
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAR566658Drug
Pharmaceutical form:solution for infusion
Route of administration: intravenous
| Study group | Role | What they receive |
|---|---|---|
| SAR566658 | Experimental | SAR566658 will be administered by intravenous (IV) infusion according to three different schedules Receives: Drug: SAR566658 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Escalation to determine the maximum tolerated dose (MTD) of SAR566658
Measured: 3 weeks
Extension Cohorts to evaluate the preliminary anti-tumoral effect of SAR566658
Measured: Anticancer activity is assessed every 6 weeks
To assess the effect of SAR566658 at the recommended dose on CYP3A enzyme activity using midazolam as probe
Measured: At D1 and D4 of administration of SAR566658 for 24h of midazolam dosing
Secondary outcomes (6)
Overall safety profile based on adverse events reporting, laboratory tests, vital signs and specific pulmonary and ocular tests, according to the NCI-CTC AE v4.03
Measured: Up to 2 years
Pharmacokinetic (PK) parameters
Measured: Up to 2 years
Immunogenicity evaluation (anti-drug antibodies)
Measured: Up to 2 years
Antitumoral response
Measured: Up to treatment discontinuation
To assess the effect of SAR566658 at recommended dose on CYP3A enzyme activity using midazolam
Measured: Up to Cycle 2
To assess safety in the alternative schedules of SAR566658 administration
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2010 (estimated)
- Study start8 Sep 2010
- Primary completion7 Apr 2017
- Study completion7 Apr 2017
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
- 114 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
- NCT01156870
- Sponsor's protocol ID
- TED10499
- Other IDs
- U1111-1116-4129
- Status last verified
- May 2017
- First submitted
- 2 Jul 2010
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Escalation, Safety and Pharmacokinetic, First in Man Study, of SAR566658 Administered as a Single Agent by Intravenous Infusion in Adult Patients With CA6-Positive and Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT01156870
- Acronym / sponsor ID
- TED10499
- Conditions
- Neoplasm Malignant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 8 Sep 2010 (actual)
- Primary completion
- 7 Apr 2017 (actual)
- Study completion
- 7 Apr 2017 (actual)
- First posted
- 5 Jul 2010 (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 determine the maximum tolerated dose (MTD) of SAR566658
Secondary Objectives:
- To characterize the safety profile of SAR566658
- To evaluate the pharmacokinetic profile of SAR566658
- To assess the potential immunogenicity of SAR566658
- To assess preliminary antitumor activity
- To assess the effect of SAR566658 at recommended dose on CYP3A enzyme activity using midazolam
- To assess safety in the alternative schedules of SAR566658 administration
Detailed description
The duration of the study for one patient in the dose escalation phase of the study will include a screening period of up to 3 weeks, a 3-week treatment cycle(s) and a 2-week treatment cycle(s). The patients may continue treatment until disease progression, unacceptable toxicity, or willingness to stop, followed by a minimum of 30-day follow-up. If a patient treated in dose escalation part or in an expansion cohorts, continues to benefit from the treatment at the time of Clinical Study Report, the patient can continue study treatment and will continue to undergo all assessments as per the study flowchart. Such patients will be followed at least until 30 days after the last IMP administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SAR566658 | Experimental | Drug: SAR566658SAR566658 will be administered by intravenous (IV) infusion according to three different schedules |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of CA6-positive solid tumors as moderate to intense membrane staining of ≥15% of tumor cells for which no standard therapy is available.
Key exclusion criteria (22 listed)
- Eastem Cooperative Oncology Group performance status ≥2.
- Any serious active disease or co-morbid condition, which, in the opinion of the Investigator, may interfere with the safety or the compliance with the study.
- Poor bone marrow reserve.
- Poor liver and renal function.
- Pregnant or breast-feeding woman.
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 |
|---|---|---|
| SAR566658Pharmaceutical form:solution for infusion Route of administration: intravenous | Drug | SAR566658 |
Primary outcome
Dose Escalation to determine the maximum tolerated dose (MTD) of SAR566658
Time frame: 3 weeks
Extension Cohorts to evaluate the preliminary anti-tumoral effect of SAR566658
Time frame: Anticancer activity is assessed every 6 weeks
To assess the effect of SAR566658 at the recommended dose on CYP3A enzyme activity using midazolam as probe
Time frame: At D1 and D4 of administration of SAR566658 for 24h of midazolam dosing
6 secondary outcomes
Overall safety profile based on adverse events reporting, laboratory tests, vital signs and specific pulmonary and ocular tests, according to the NCI-CTC AE v4.03
Time frame: Up to 2 years
Pharmacokinetic (PK) parameters
Time frame: Up to 2 years
Immunogenicity evaluation (anti-drug antibodies)
Time frame: Up to 2 years
Antitumoral response
Time frame: Up to treatment discontinuation
To assess the effect of SAR566658 at recommended dose on CYP3A enzyme activity using midazolam
Time frame: Up to Cycle 2
To assess safety in the alternative schedules of SAR566658 administration
Time frame: Up to 2 years
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 10 May 2017.
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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
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SAR566658 in people with Neoplasm Malignant, run by Sanofi at 5 sites in 3 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 22 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 10 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Spain, France. 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 Escalation to determine the maximum tolerated dose (MTD) of SAR566658 (time frame: 3 weeks). The study lists 3 primary outcomes in all. 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 10 May 2017.