Phase 1 Safety Testing of SAR405838
This study is currently recruiting participants.
Verified May 2013 by Sanofi
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01636479
First received: July 2, 2012
Last updated: May 16, 2013
Last verified: May 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Neoplasm Malignant |
Drug: SAR405838 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Biological Activity of SAR405838 in Patients With Advanced Cancer |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- SAR405838 Maximum tolerated dose (MTD) [ Time Frame: Cycle 1 (21 days) ] [ Designated as safety issue: Yes ]
- In MTD cohort, clinical benefit [ Time Frame: Until disease progression ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Adverse events (eg, number of patients experiencing AEs) [ Time Frame: Baseline to end of study ] [ Designated as safety issue: Yes ]
- PK parameters (Cmax, Tmax, AUC) [ Time Frame: Baseline to end of study ] [ Designated as safety issue: No ]
- Biomarkers [ Time Frame: Baseline to end of study ] [ Designated as safety issue: No ]
- Clinical response [ Time Frame: Baseline to end of study ] [ Designated as safety issue: No ]
- Drug administration compliance [ Time Frame: Baseline to end of study ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 82 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | February 2015 |
| Estimated Primary Completion Date: | February 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: SAR405838
SAR405838 in escalating doses
|
Drug: SAR405838
Pharmaceutical form: Capsule Route of administration: Oral
|
Detailed Description:
Total duration of study participation for each patient will be one month screening + 6 months from the first dose.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01636479
Contacts
| Contact: For site information, send an email with site number to | Contact-Us@Sanofi.com |
Locations
| Netherlands | |
| Investigational Site Number 528001 | Recruiting |
| Amsterdam, Netherlands, 1066 CX | |
| Investigational Site Number 528003 | Recruiting |
| Rotterdam, Netherlands, 3075 EA | |
| Investigational Site Number 528002 | Recruiting |
| Utrecht, Netherlands, 3584 CX | |
Sponsors and Collaborators
Sanofi
Investigators
| Study Director: | Clinical Sciences & Operations | Sanofi |
More Information
No publications provided
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT01636479 History of Changes |
| Other Study ID Numbers: | TED12318, 2012-000733-39, U1111-1127-2911 |
| Study First Received: | July 2, 2012 |
| Last Updated: | May 16, 2013 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Additional relevant MeSH terms:
|
Neoplasms |
ClinicalTrials.gov processed this record on May 16, 2013