Neoplasm MalignantPhase 1NCT01985191
A Safety and Efficacy Study of SAR405838 and Pimasertib in Cancer Patients
A Phase 1 study testing SAR405838 and Pimasertib in people with Neoplasm Malignant, run by Sanofi at 4 sites in 2 countries.
Trial summary
Primary Objectives: To determine the recommended Phase 2 dose of SAR405838 / pimasertib combination therapy in patients with solid tumors. To assess the anti-tumor activities of SAR405838 / pimasertib in patients with 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?
- SAR405838 and Pimasertib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Nov 2013to Feb 2016
- 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 diagnosis of a solid tumor.
- Presence of locally advanced or metastatic disease with at least one measurable lesion.
- Ability to provide written informed consent. Evidence of a personally signed informed consent.
Who cannot join
- Age <18 years.
- Eastern Cooperative Oncology Group performance status of >1.
- Inadequate functions of bone marrow, liver, and kidney.
- Positive pregnancy test in women of child-bearing potential.
- Pregnancy or breast-feeding.
- Extensive prior radiotherapy.
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- The patient has retinal degenerative disease, history of uveitis, or history of retinal vein occlusion, or history of retinal detachment, or has medically relevant abnormalities identified on screening ophthalmologic examination.
- Prior history of myositis or rhabdomyolysis.
- Recent major surgery or trauma, unhealing/open wounds.
- The patient has had congestive heart failure, unstable angina, a myocardial infarction, cardiac conduction abnormality or pacemaker or a stroke within 3 months of entering the study.
- The patient has a baseline corrected QT interval (QTc) >480 ms or left ventricular ejection fraction (LVEF) <50% or less than the lower limit of normal.
- The patient has a previously-identified allergy or hypersensitivity to components of the study treatment formulations.
- Unwillingness or inability to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions.
- Unwillingness, if not postmenopausal or surgically sterile, to abstain from sexual intercourse or employ an effective barrier or medical method of contraception during the study drug administration and follow-up periods.
- Recent history of acute pancreatitis.
- Clinically significant illness, medical condition, surgical history, physical finding, or laboratory abnormality that could affect the safety of the patient; alter the absorption of the study drugs; or impair the assessment of study results.
- 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
4 sites in 2 countries.
4 sites in 2 countries
Netherlands3 sites
Investigational Site Number 528001
Amsterdam, 1066 CX
Investigational Site Number 528003
Rotterdam, 3075 EA
Investigational Site Number 528002
Utrecht, 3584 CX
About this study
Official title: A Phase 1 Study of Combination Therapy With SAR405838 and Pimasertib in Patients With Advanced Cancer
Primary Objectives:
To determine the recommended Phase 2 dose of SAR405838 / pimasertib combination therapy in patients with solid tumors.
To assess the anti-tumor activities of SAR405838 / pimasertib in patients with solid tumors.
Secondary Objectives:
To characterize the pharmacokinetic profile of SAR405838 and pimasertib.
To evaluate the pharmacodynamic effect of the SAR405838 and pimasertib.
To characterize genetic status in tumor tissue and circulating tumor DNA.
Read the detailed description
The duration of the study for an individual patient will include a period to assess eligibility of up to 4 weeks, a treatment period of at least 6 weeks of study treatment, and an end-of-study visit at least 30 days (or until the patient receives another anti-cancer therapy, whichever is shorter) following the last administration of study drug.
- Conditions
- Neoplasm Malignant
- Being tested
- SAR405838, Pimasertib
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAR405838Drug
Pharmaceutical form:capsule
Route of administration: oral
PimasertibDrug
Pharmaceutical form: capsule
Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | SAR405838 and pimasertib in escalating doses Receives: Drug: SAR405838; Drug: Pimasertib |
What is being measured
The primary outcome is the main question the study is designed to answer.
SAR405838 (pimasertib) RP2D assessed by dose-limiting toxicities and pharmacological activities
Measured: 6 weeks for each patient at each dose level
Changes of tumor dimension by imaging
Measured: At least 3 months for each patient
Secondary outcomes (7)
Overall safety profile of SAR405838 (pimasertib), number of participants with adverse events
Measured: Throughout the study
Pharmacokinetic parameters for both SAR405838 (pimasertib): the maximum concentration in blood (Cmax)
Measured: 3 months for each patient
Pharmacokinetic parameters for both SAR405838 (pimasertib): time to the maximum concentration (Tmax)
Measured: 3 months for each patient
Pharmacokinetic parameters for both SAR405838 (pimasertib): area under the curve (AUC), etc.
Measured: 3 months for each patient
Biomarker changes in response to SAR405838 (pimasertib) treatment
Measured: 3 months for each patient
Genetic status in tumor tissue
Measured: Baseline
Change of the genetic status of circulating tumor DNA
Measured: Baseline and until disease progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionFeb 2016
- Study completionFeb 2016
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 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01985191
- Sponsor's protocol ID
- TCD13388
- Other IDs
- 2013-002325-33, U1111-1144-8349
- Status last verified
- Feb 2016
- First submitted
- 31 Oct 2013
- Last updated
- 25 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
de Weger VA, de Jonge M, Langenberg MHG, Schellens JHM, Lolkema M, Varga A, Demers B, Thomas K, Hsu K, Tuffal G, Goodstal S, Mace S, Deutsch E. A phase I study of the HDM2 antagonist SAR405838 combined with the MEK inhibitor pimasertib in patients with advanced solid tumours. Br J Cancer. 2019 Feb;120(3):286-293. doi: 10.1038/s41416-018-0355-8. Epub 2018 Dec 26.
PubMed 30585255
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of Combination Therapy With SAR405838 and Pimasertib in Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT01985191
- Acronym / sponsor ID
- TCD13388
- Conditions
- Neoplasm Malignant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Study start
- Nov 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 15 Nov 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 Objectives:
To determine the recommended Phase 2 dose of SAR405838 / pimasertib combination therapy in patients with solid tumors.
To assess the anti-tumor activities of SAR405838 / pimasertib in patients with solid tumors.
Secondary Objectives:
To characterize the pharmacokinetic profile of SAR405838 and pimasertib.
To evaluate the pharmacodynamic effect of the SAR405838 and pimasertib.
To characterize genetic status in tumor tissue and circulating tumor DNA.
Detailed description
The duration of the study for an individual patient will include a period to assess eligibility of up to 4 weeks, a treatment period of at least 6 weeks of study treatment, and an end-of-study visit at least 30 days (or until the patient receives another anti-cancer therapy, whichever is shorter) following the last administration of study drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: SAR405838, Drug: PimasertibSAR405838 and pimasertib in escalating doses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically or cytologically confirmed diagnosis of a solid tumor.
- Presence of locally advanced or metastatic disease with at least one measurable lesion.
- Ability to provide written informed consent. Evidence of a personally signed informed consent.
Key exclusion criteria (17 listed)
- Age <18 years.
- Eastern Cooperative Oncology Group performance status of >1.
- Inadequate functions of bone marrow, liver, and kidney.
- Positive pregnancy test in women of child-bearing potential.
- Pregnancy or breast-feeding.
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 |
|---|---|---|
| SAR405838Pharmaceutical form:capsule Route of administration: oral | Drug | Arm 1 |
| PimasertibPharmaceutical form: capsule Route of administration: oral | Drug | Arm 1 |
Primary outcome
SAR405838 (pimasertib) RP2D assessed by dose-limiting toxicities and pharmacological activities
Time frame: 6 weeks for each patient at each dose level
Changes of tumor dimension by imaging
Time frame: At least 3 months for each patient
7 secondary outcomes
Overall safety profile of SAR405838 (pimasertib), number of participants with adverse events
Time frame: Throughout the study
Pharmacokinetic parameters for both SAR405838 (pimasertib): the maximum concentration in blood (Cmax)
Time frame: 3 months for each patient
Pharmacokinetic parameters for both SAR405838 (pimasertib): time to the maximum concentration (Tmax)
Time frame: 3 months for each patient
Pharmacokinetic parameters for both SAR405838 (pimasertib): area under the curve (AUC), etc.
Time frame: 3 months for each patient
Biomarker changes in response to SAR405838 (pimasertib) treatment
Time frame: 3 months for each patient
Genetic status in tumor tissue
Time frame: Baseline
Change of the genetic status of circulating tumor DNA
Time frame: Baseline and until disease progression
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 25 Feb 2016.
- Derived from this study: PubMed 30585255de Weger VA, de Jonge M, Langenberg MHG, Schellens JHM, Lolkema M, Varga A, Demers B, Thomas K, Hsu K, Tuffal G, Goodstal S, Mace S, Deutsch E. A phase I study of the HDM2 antagonist SAR405838 combined with the MEK inhibitor pimasertib in patients with advanced solid tumours. Br J Cancer. 2019 Feb;120(3):286-293. doi: 10.1038/s41416-018-0355-8. Epub 2018 Dec 26.
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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
4 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 SAR405838 and Pimasertib in people with Neoplasm Malignant, run by Sanofi at 4 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 3 inclusion and 17 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 25 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands, 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?
SAR405838 (pimasertib) RP2D assessed by dose-limiting toxicities and pharmacological activities (time frame: 6 weeks for each patient at each dose level). The study lists 2 primary outcomes in all. 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 NCT01985191, 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 25 Feb 2016.