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Trial of Pimasertib With SAR245409 or Placebo in Ovarian Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
EMD Serono
ClinicalTrials.gov Identifier:
NCT01936363
First received: August 23, 2013
Last updated: July 28, 2017
Last verified: July 2017
Results First Received: May 31, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Ovarian Cancer
Interventions: Drug: Pimasertib once daily
Drug: Pimasertib placebo
Drug: SAR245409 placebo
Drug: SAR245409
Drug: Pimasertib twice daily

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First/last subject (informed consent): Sep 2012/Oct 2014. Clinical data cut off: May 2015, Study completion date: May 2015

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Pimasertib (Once Daily) Plus SAR245409 Subjects received Pimasertib oral capsule at a dose of 60 milligram (mg) once daily along with SAR245409 oral capsule at a dose of 70 mg once daily and placebo matching to pimasertib in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
Pimasertib (Twice Daily) Plus SAR245409 Placebo Subjects received pimasertib oral capsule at a dose of 60 mg twice daily along with placebo matching to SAR245409 once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.

Participant Flow:   Overall Study
    Pimasertib (Once Daily) Plus SAR245409   Pimasertib (Twice Daily) Plus SAR245409 Placebo
STARTED   32   33 
COMPLETED   25   28 
NOT COMPLETED   7   5 
Ongoing                7                5 



  Baseline Characteristics
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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.
Intent-To Treat (ITT) analysis set included all subject who were randomized.

Reporting Groups
  Description
Pimasertib (Once Daily) Plus SAR245409 Subjects received pimasertib oral capsule at a dose of 60 milligram (mg) once daily along with SAR245409 oral capsule at a dose of 70 mg once daily and placebo matching to pimasertib in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
Pimasertib (Twice Daily) Plus SAR245409 Placebo Subjects received pimasertib oral capsule at a dose of 60 mg twice daily along with placebo matching to SAR245409 once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
Total Total of all reporting groups

Baseline Measures
   Pimasertib (Once Daily) Plus SAR245409   Pimasertib (Twice Daily) Plus SAR245409 Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 32   33   65 
Age 
[Units: Years]
Mean (Standard Deviation)
 47.3  (14.07)   50.6  (16.39)   49.0  (15.26) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      32 100.0%      33 100.0%      65 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Objective Tumor Response   [ Time Frame: From randomization until disease progression or death assessed every 8 weeks up to week 32, and thereafter every 12 weeks up to Data Cut-off (19 May 2015) ]

2.  Secondary:   Progression-Free Survival   [ Time Frame: Time from randomization until first observation of progressive disease or death, assessed up to Data Cut-off (19 May 2015) ]

3.  Secondary:   Percentage of Subjects With Disease Control   [ Time Frame: Randomization until disease progression or death assessed every 8 weeks up to week 32, and thereafter every 12 weeks up to Data Cut-off (19 May 2015) ]

4.  Secondary:   Overall Survival   [ Time Frame: Time from randomization until death, assessed up to Data Cut-off (19 May 2015) ]

5.  Secondary:   Health Related Quality of Life (HrQoL) Assessed Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30)   [ Time Frame: Baseline up to disease progression or withdrawal, assessed up to Data Cut-off (19 May 2015) ]

6.  Secondary:   Health Related Quality of Life (HrQoL) Assessed Using European Organization for Research and Treatment of Cancer (EORTC) Ovarian-Specific Module Quality of Life Questionnaire Ovarian Cancer Module (QLQ-OV28)   [ Time Frame: Baseline up to disease progression or withdrawal, assessed up to Data Cut-off (19 May 2015) ]

7.  Secondary:   Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), TEAEs Leading to Discontinuation of Treatment and Death   [ Time Frame: First dose of study drug up to Data Cut-off (19 May 2015) ]

8.  Secondary:   Maximum Plasma Concentration (Cmax) After Dose of Pimasertib and SAR245409   [ Time Frame: Pre-dose Hour 0.5, 1.5, 4.5 8 post dose on Day 15, 29, 43 ]

9.  Secondary:   Area Under the Curve (AUC) After Dose of Pimasertib and SAR245409   [ Time Frame: Pre-dose Hour 0.5, 1.5, 4.5 8 post dose on Day 15, 29, 43 ]

10.  Secondary:   Molecular Alterations in MAPK and/or PI3K Signaling Pathway Components/Modulators in Tumor Tissue and Blood   [ Time Frame: Screening visit (day -28 to 1) ]


  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
An interim analysis for futility was introduced by IDMC recommendation and new subject enrollment was permanently discontinued as it would be futile to continue the trial as planned. Few participants who were enrolled are still ongoing treatment.


  More Information
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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 Healthcare, a business of Merck KGaA, Darmstadt, Germany
phone: +49-6151-72-5200
e-mail: service@merckgroup.com



Responsible Party: EMD Serono
ClinicalTrials.gov Identifier: NCT01936363     History of Changes
Other Study ID Numbers: EMR 200066_012
2013-000902-40 ( EudraCT Number )
Study First Received: August 23, 2013
Results First Received: May 31, 2016
Last Updated: July 28, 2017