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Trial of MEK Inhibitor and PI3K/mTOR Inhibitor in Subjects With Locally Advanced or Metastatic Solid Tumors

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
EMD Serono
ClinicalTrials.gov Identifier:
NCT01390818
First received: April 18, 2011
Last updated: January 17, 2017
Last verified: January 2017
Results First Received: May 1, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Locally Advanced Solid Tumor
Metastatic Solid Tumor
Breast Cancer
Non Small Cell Lung Cancer
Melanoma
Colorectal Cancer
Interventions: Drug: MSC1936369B (pimasertib)
Drug: SAR245409 (PI3K and mTOR inhibitor)

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First subject (informed consent): May 2011. Study completion date: Apr 2015. A total of 192 subjects were screened and 146 subjects entered the trial and received the investigational medicinal product (IMP).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Study had a 4-day Drug-Drug Interaction (DDI) period, within 1 week prior to Day 1 Cycle 1, to assess possible interaction only in selected subjects where in SAR245409 and Pimasertib were administered alone on Day 1 and Day 3, respectively.

Reporting Groups
  Description
Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (Dose Escalation [DE] cohort).
Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 90 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 60 mg along with twice oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 45 mg along with twice oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
CRC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
MEL: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.

Participant Flow:   Overall Study
    Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily   Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily   Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily   Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily   Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily   Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily   Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily   Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily   Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily   Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily   Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily   TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily   NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily   CRC: Pimasertib 60mg and SAR245409 70mg Once Daily   MEL: Pimasertib 60mg and SAR245409 70mg Once Daily
STARTED   3   3   3   4   4   3   19   14   3   3   4   26   24   18   15 
COMPLETED   3   3   3   4   4   3   19   14   3   3   4   26   24   18   15 
NOT COMPLETED   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Safety analysis set (SAF) included subjects who received at least one (non-zero) administration of the trial IMPs (pimasertib and/or SAR245409).

Reporting Groups
  Description
Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 90 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 60 mg along with twice oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 45 mg along with twice oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
CRC: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
MEL: Pimasertib 60mg and SAR245409 70mg Once Daily Subjects with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
Total Total of all reporting groups

Baseline Measures
   Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily   Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily   Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily   Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily   Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily   Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily   Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily   Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily   Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily   Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily   Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily   TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily   NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily   CRC: Pimasertib 60mg and SAR245409 70mg Once Daily   MEL: Pimasertib 60mg and SAR245409 70mg Once Daily   Total 
Overall Participants Analyzed 
[Units: Participants]
 3   3   3   4   4   3   19   14   3   3   4   26   24   18   15   146 
Age 
[Units: Participants]
Count of Participants
                               
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      2  66.7%      1  33.3%      1  33.3%      2  50.0%      1  25.0%      2  66.7%      16  84.2%      12  85.7%      3 100.0%      2  66.7%      2  50.0%      22  84.6%      16  66.7%      12  66.7%      13  86.7%      107  73.3% 
>=65 years      1  33.3%      2  66.7%      2  66.7%      2  50.0%      3  75.0%      1  33.3%      3  15.8%      2  14.3%      0   0.0%      1  33.3%      2  50.0%      4  15.4%      8  33.3%      6  33.3%      2  13.3%      39  26.7% 
Gender 
[Units: Participants]
Count of Participants
                               
Female      3 100.0%      1  33.3%      2  66.7%      1  25.0%      1  25.0%      1  33.3%      6  31.6%      13  92.9%      1  33.3%      2  66.7%      0   0.0%      26 100.0%      15  62.5%      11  61.1%      4  26.7%      87  59.6% 
Male      0   0.0%      2  66.7%      1  33.3%      3  75.0%      3  75.0%      2  66.7%      13  68.4%      1   7.1%      2  66.7%      1  33.3%      4 100.0%      0   0.0%      9  37.5%      7  38.9%      11  73.3%      59  40.4% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Subjects With Dose Limiting Toxicities (DLT)   [ Time Frame: Day 1 up to Day 16 in cycle 1 ]

2.  Secondary:   Number of Subjects Experiencing Any Treatment-Emergent Adverse Events (TEAEs)   [ Time Frame: Baseline up to 30 Days after last dose; assessed up to 4 years ]

3.  Secondary:   Maximum Observed Plasma Concentration (Cmax) for Pimasertib (MSC1936369B)   [ Time Frame: Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts ]

4.  Secondary:   Time to Reach Maximum Plasma Concentration (Tmax) of Pimasertib (MSC1936369B)   [ Time Frame: Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts ]

5.  Secondary:   Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to the Last Sampling Time (0-24 Hours) of Pimasertib (MSC1936369B)   [ Time Frame: Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts ]

6.  Secondary:   Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC 0-inf) of Pimasertib (MSC1936369B) at Day 1   [ Time Frame: Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1 for DE cohorts ]

7.  Secondary:   Area Under the Concentration-Time Curve (AUC) During a Dosing Interval (Tau) of Pimasertib (MSC1936369B)   [ Time Frame: Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts ]

8.  Secondary:   Half-Life (t1/2) of MSC1936369B (Pimasertib)   [ Time Frame: Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts ]

9.  Secondary:   Total Body Clearance (CL/f) of Pimasertib (MSC1936369B)   [ Time Frame: Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts ]

10.  Secondary:   Apparent Volume of Distribution of Total Pimasertib During the Terminal Phase Following Oral Administration (Vz/f) of Pimasertib   [ Time Frame: Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts ]

11.  Secondary:   Accumulation Ratio (Racc) for AUCtau of Pimasertib (MSC1936369B): Day 15   [ Time Frame: Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts ]

12.  Secondary:   Accumulation Ratio (Racc) for Cmax of Pimasertib (MSC1936369B): Day 15   [ Time Frame: Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts ]

13.  Secondary:   Maximum Observed Plasma Concentration (Cmax) for SAR245409   [ Time Frame: Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts ]

14.  Secondary:   Time to Reach Maximum Plasma Concentration (Tmax) of SAR245409   [ Time Frame: Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts ]

15.  Secondary:   Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to the Last Sampling Time (0-24 Hours) of SAR245409   [ Time Frame: Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts ]

16.  Secondary:   Area Under the Concentration-Time Curve (AUC) During a Dosing Interval (Tau) of SAR245409   [ Time Frame: Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts ]

17.  Secondary:   Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to Infinity (0-inf) of SAR245409: Day 1   [ Time Frame: Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1 for DE cohorts ]

18.  Secondary:   Apparent Terminal Half-Life (t1/2) of SAR245409   [ Time Frame: Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts ]

19.  Secondary:   Total Body Clearance (CL/f) of SAR245409   [ Time Frame: Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts ]

20.  Secondary:   Apparent Volume of Distribution of Total SAR245409 During the Terminal Phase Following Oral Administration (Vz/f)   [ Time Frame: Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts ]

21.  Secondary:   Accumulation Ratio (Racc) for AUCtau of SAR245409: Day 15   [ Time Frame: Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts ]

22.  Secondary:   Accumulation Ratio (Racc) for Cmax of SAR245409: Day 15   [ Time Frame: Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts ]

23.  Secondary:   pS6 Concentrations in Peripheral Blood Mononuclear Cells (PBMCs)   [ Time Frame: DDI Evaluation: Day 1 and 3 (predose, 2, 4, 8 and 24 hours (hr) postdose); Day 2 and 4 (24 hr postdose); Cycle 1 Day 1 (C1D1) and C1D15 (predose, 2, 4, 8, 24 hr postdose); C1D2 and C1D16 (24 hr postdose); C1D19 (predose, 2 hr postdose) ]

24.  Secondary:   pERK Concentrations in PBMCs   [ Time Frame: DDI Evaluation: Day 1 and 3 (predose, 2, 4, 8 and 24 hours (hr) postdose); Day 2 and 4 (24 hr postdose); C1D1 and C1D15 (predose, 2, 4, 8, 24 hr postdose); C1D2 and C1D16 (24 hr postdose); C1D19 (predose, 2 hr postdose) ]

25.  Secondary:   Number of Subjects With Complete Tumor Response (CR), Partial Tumor Response (PR), or Stable Disease (SD)   [ Time Frame: From the date of randomisation every 6 weeks up to assessed up to 4 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Merck KGaA Communication Center
Organization: Merck Serono, a business of Merck KGaA, Darmstadt, Germany
phone: +496151725200
e-mail: service@merckgroup.com



Responsible Party: EMD Serono
ClinicalTrials.gov Identifier: NCT01390818     History of Changes
Other Study ID Numbers: EMR 200066-006
Study First Received: April 18, 2011
Results First Received: May 1, 2016
Last Updated: January 17, 2017