Clinical Trials Logo

Clinical Trial Summary

Primary Objective: The purpose of this study was to determine the long term safety and tolerability of SAR245408 and SAR245409 as a monotherapy or as part of a combination regimen in participants who were benefiting from treatment.


Clinical Trial Description

The duration of the study for an individual participant included: 1. Baseline assessments: within 7 days prior to the first dose of investigational medicinal product (IMP). 2. Study treatment period(s): Participants started study treatment at the beginning of the initiation or extension periods based on the length of prior therapy with SAR245408 or SAR245409 - if <2 cycles, started with initiation period; Participant must have had completed all the visits in the initiation period before moving to the extension period. - if >=2 cycles, started with extension period; duration of extension period was unlimited. - Participants who took a SAR245408 or SAR245409 daily dose higher than their established dose of SAR245408 or SAR245409, respectively, in the parental study entered the study on Day 1 of the initiation period. - Participants who had dose interrupted in the parental study but fulfilled parental protocol criteria to restart IMP treatment entered the treatment-extension study on Day 1 of the initiation period. - Participants who fulfilled the parental study criteria for IMP treatment continuation but had ongoing Grade 2 adverse events (AEs) entered the treatment-extension study on Day 1 of the initiation period. Participants continued to receive study treatment until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245408 or SAR245409 were available to them outside of the clinical trial. 3. Follow-up assessments: 23 to 37 days after the last dose of IMP. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01587040
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 1/Phase 2
Start date July 20, 2012
Completion date May 23, 2018

See also
  Status Clinical Trial Phase
Completed NCT01156870 - First in Man Study of SAR566658 Administered in Patients With CA6-Positive and Refractory Solid Tumor Phase 1
Active, not recruiting NCT03667716 - COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors. Phase 1
Completed NCT01930552 - A Phase I Study of Aflibercept Plus FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) in Chinese Patients With Advanced Solid Malignancies Phase 1
Completed NCT01657214 - Phase I, Dose Escalation of SAR125844 in Asian Solid Tumor Patients Phase 1
Active, not recruiting NCT03911388 - HSV G207 in Children With Recurrent or Refractory Cerebellar Brain Tumors Phase 1
Completed NCT02575781 - A Study of SAR428926 in Patients With Advanced Solid Tumors Phase 1
Completed NCT01943838 - A Study of the Safety and Pharmacokinetics of SAR245408 Tablets in Patients With Solid Tumors or Lymphoma Phase 1
Completed NCT03324113 - Evaluation of SAR408701 in Japanese Patients With Advanced Malignant Solid Tumors Phase 1
Recruiting NCT06238687 - A Study of STRO-002 in Chinese Adults With Epithelial Ovarian Cancer and Other Advanced Malignant Solid Tumors Phase 1/Phase 2
Completed NCT02435121 - A Study Assessing Efficacy and Safety of SAR125844 in NSCLC Patients With MET Amplification Phase 2
Completed NCT01985191 - A Safety and Efficacy Study of SAR405838 and Pimasertib in Cancer Patients Phase 1
Completed NCT01455532 - A Dose Escalation Study of Iniparib as a Single Agent and in Combination in Solid Tumors Phase 1
Active, not recruiting NCT03491631 - Phase I Study of SHR9146 + SHR-1210 +/- Apatinib in Patients With Advanced Solid Tumors Phase 1
Recruiting NCT04067388 - iKnife REIMS Project
Completed NCT01836705 - Effect of SAR302503 on ECG Activity in Patients With Solid Tumors Phase 1
Completed NCT01140607 - Safety and Pharmacokinetic Study of Cabazitaxel in Patients With Advanced Solid Tumors and Liver Impairment Phase 1
Recruiting NCT04495790 - AIMS Cancer Outcomes Study
Recruiting NCT05714553 - NUC-3373 in Combination With Other Agents in Patients With Advanced Solid Tumours Phase 1/Phase 2
Recruiting NCT04733469 - EMPOWER 3: Improving Palliative Care Health Literacy and Utilization N/A
Active, not recruiting NCT03845166 - A Study of XL092 as Single-Agent and Combination Therapy in Subjects With Solid Tumors Phase 1