CompletedNCT01636479Updated May 17, 2018

Phase 1 Safety Testing of SAR405838

A Phase 1 interventional study of SAR405838 in Neoplasm Malignant, sponsored by Sanofi. Completed at 7 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-17.

Sponsored by Sanofi · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 77
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study summary

Primary Objectives:

To determine safety and the maximum tolerated dose (MTD) of SAR405838 through the characterization of dose-limiting toxicities (DLTs).
To assess biological activities in patients with dedifferentiated liposarcoma during MTD cohort expansion.

Secondary Objectives:

Pharmacokinetic (PK) profile of SAR405838.
Biomarkers in association with SAR405838.
Anti-tumor activity in response to SAR405838.
Food effect on SAR405838 PK.
Compliance with SAR405838 treatment.
Cytochrome P450 3A4/5 (CYP3A4/5) activity.

Read the detailed description

Total duration of study participation for each patient will be one month screening followed by treatment until precluded by toxicity, noncompliance, progression, or death.

Conditions studied

Neoplasm Malignant

Browse trials for

Neoplasms 9,616

In context

Neoplasms

9,616 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.

This study's enrollment of 77 is above the median of 50 across 7,429 interventional studies indexed under Neoplasms.

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Lead sponsor

Sanofi is the lead sponsor of 1,548 studies on the registry; 88 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 122 (60%) have results posted.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Histologically or cytologically confirmed diagnosis of a solid tumor for which no further effective standard treatment is available. Patients with lymphomas may be enrolled.
For dose escalation, tumor type that has high biomarker prevalence without molecular confirmation of biomarker status, or any tumor type with molecular confirmation of biomarker status; For MTD cohort expansion, only dedifferentiated liposarcoma will be included.
Presence of locally advanced or metastatic disease with at least one measurable lesion.

Exclusion criteria

Exclusion criteria:

Age \<18 years.
Eastern Cooperative Oncology Group (ECOG) performance status of >1.
Life expectancy \<12 weeks.
Unstable brain or leptomeningeal disease based on history and physical examination.
Inadequate organ functions, positive pregnancy test.
Pregnancy or breast-feeding.
Any anti-cancer drug therapy within 2 weeks (8 weeks for mitomycin C or nitrosoureas) or 5 half-lives of the drug prior to study treatment, whichever is shorter, prior to study treatment.
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 (3 months) history of acute pancreatitis.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 77 participants (actual)

Study arms

Experimental
SAR405838
SAR405838 in escalating doses
Drug: SAR405838

Interventions

DrugSAR405838
Pharmaceutical form: Capsule Route of administration: Oral

What researchers measure

Primary outcomes

SAR405838 Maximum tolerated dose (MTD)
Time frame: Cycle 1 (21 days) or 2 Cycles (42 days) dependent on dosing schedule
In MTD cohort, clinical benefit
Time frame: Until disease progression

Secondary outcomes

Adverse events (eg, number of patients experiencing AEs)
Time frame: Baseline to end of study
PK parameters (Cmax, Tmax, AUC)
Time frame: Baseline to end of study
Biomarkers
Time frame: Baseline to end of study
Clinical response
Time frame: Baseline to end of study
Drug administration compliance
Time frame: Baseline to end of study

Study locations

7 sites

Investigational Site Number 840101
Boston, Massachusetts 02114, United States
Investigational Site Number 840001
Boston, Massachusetts 02115, United States
Investigational Site Number 840002
New York, New York 10021, United States
Investigational Site Number 250001
Villejuif, 94805, France
Investigational Site Number 528001
Amsterdam, 1066 CX, Netherlands
Investigational Site Number 528003
Rotterdam, 3075 EA, Netherlands
Investigational Site Number 528002
Utrecht, 3584 CX, Netherlands

References and documents

Publications

de Jonge M, de Weger VA, Dickson MA, Langenberg M, Le Cesne A, Wagner AJ, Hsu K, Zheng W, Mace S, Tuffal G, Thomas K, Schellens JH. A phase I study of SAR405838, a novel human double minute 2 (HDM2) antagonist, in patients with solid tumours. Eur J Cancer. 2017 May;76:144-151. doi: 10.1016/j.ejca.2017.02.005. Epub 2017 Mar 17. PubMed 28324749 ↗

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2012, a primary completion of Mar 2018 and a completion of Mar 2018. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered: Jul 2, 2012
First posted: Jul 10, 2012
Start: Jul 13, 2012
Primary completionActual: Mar 5, 2018
CompletionActual: Mar 5, 2018
Last update: May 17, 2018

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on May 17, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01636479
Lead sponsor: Sanofi
Responsible party: Sponsor
First posted: Jul 10, 2012
Start date: Jul 13, 2012
Primary completion: Mar 5, 2018
Completion: Mar 5, 2018
Last update: May 17, 2018

Study contacts

Clinical Sciences & Operations

study director · Sanofi

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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