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MSC2015103B in Solid Tumors

This study has been terminated.
(Due to an administrative reason)
Sponsor:
Information provided by (Responsible Party):
EMD Serono
ClinicalTrials.gov Identifier:
NCT01453387
First received: September 9, 2011
Last updated: March 27, 2017
Last verified: March 2017
Results First Received: April 8, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Advanced Solid Tumor
Intervention: Drug: MSC2015103B

  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): 09 September 2011/18 April 2013. Study completion date: 15 July 2013, Clinical data cut-off date: 15 July 2013; Subjects were randomized at 3 centers in United States.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Enrolled: 28 subjects were screened for eligibility and all were randomized in to the trial.

Reporting Groups
  Description
Part 1 - MSC2015103B (Schedule 1) MSC2015103B was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle until maximum tolerated dose (MTD) was established. Starting dose was 150 microgram (mcg), which was escalated to 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg subsequently.
Part 1 - MSC2015103B (Schedule 2) MSC2015103B was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle until MTD was established. Starting dose was 150 mcg, and was escalated to 200 mcg subsequently.

Participant Flow:   Overall Study
    Part 1 - MSC2015103B (Schedule 1)   Part 1 - MSC2015103B (Schedule 2)
STARTED   21   7 
COMPLETED   21   7 
NOT COMPLETED   0   0 



  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.
Safety analysis set included all subjects who received at least one administration of the trial medication.

Reporting Groups
  Description
Part 1 - MSC2015103B (Schedule 1) MSC2015103B was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle until maximum tolerated dose (MTD) was established. Starting dose was 150 microgram (mcg), which was escalated to 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg subsequently.
Part 1 - MSC2015103B (Schedule 2) MSC2015103B was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle until MTD was established. Starting dose was 150 mcg, and was escalated to 200 mcg subsequently.
Total Total of all reporting groups

Baseline Measures
   Part 1 - MSC2015103B (Schedule 1)   Part 1 - MSC2015103B (Schedule 2)   Total 
Overall Participants Analyzed 
[Units: Participants]
 21   7   28 
Age, Customized 
[Units: Subjects]
     
18 to less than (<) 45 years   2   0   2 
Greater than equal to (>=) 45 to <65 years   10   5   15 
>=65 years   9   2   11 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      4  19.0%      4  57.1%      8  28.6% 
Male      17  81.0%      3  42.9%      20  71.4% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Subjects Who Experienced Dose-limiting Toxicities (DLT)   [ Time Frame: Up to Day 21 of Cycle 1 ]

2.  Primary:   Percentage of Subjects Who Experienced DLT   [ Time Frame: Up to Day 21 of Cycle 1 ]

3.  Secondary:   Percentage of Subjects Who Experienced Any Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death and TEAEs Leading to Discontinuation   [ Time Frame: From the initiation of the trial till the data cut-off date 15 July 2013 ]

4.  Secondary:   Percentage of Subjects Who Experienced Clinically Significant Lab Abnormality Judged to be Related to the Trial Medication   [ Time Frame: From the initiation of the trial till the data cut-off date 15 July 2013 ]

5.  Secondary:   Number of Subjects Who Experienced Clinically Significant Lab Abnormality Judged to be Related to the Trial Medication   [ Time Frame: From the initiation of the trial till the data cut-off date 15 July 2013 ]

6.  Secondary:   Maximum Plasma Concentration (Cmax)   [ Time Frame: Schedule 1 : 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, 24.0, 48 or 72, 72 or 96 and 168 hours post-dose during Week 1 and Week 3; Schedule 2: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, and 24.0 hours post-dose on Days 1 and 17. ]

7.  Secondary:   Time to Reach Maximum Plasma Concentration (Tmax)   [ Time Frame: Schedule 1: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, 24.0, 48 or 72, 72 or 96 and 168 hours post-dose during Week 1 and Week 3; Schedule 2: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, and 24.0 hours post-dose on Day 1 and 17. ]

8.  Secondary:   Apparent Terminal Half Life (T1/2)   [ Time Frame: Schedule 1: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, 24.0, 48 or 72, 72 or 96 and 168 hours post-dose during Week 1 and Week 3; Schedule 2: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, and 24.0 hours post-dose on Day 1 and 17. ]

9.  Secondary:   Area Under the Plasma Concentration Curve From Time Zero to Infinity (AUC[0-inf])   [ Time Frame: Schedule 1: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, 24.0, 48 or 72, 72 or 96 and 168 hours post-dose during Week 1 and Week 3; Schedule 2: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, and 24.0 hours post-dose on Day 1 and 17. ]

10.  Secondary:   AUC Versus Time Curve Within One Dosing Interval (AUC0-tau)   [ Time Frame: Schedule 1: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, 24.0, 48 or 72, 72 or 96 and 168 hours post-dose during Week 1 and Week 3; Schedule 2: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, and 24.0 hours post-dose on Day 1 and 17. ]

11.  Secondary:   Apparent Oral Clearance of the Drug From Plasma (CL/f)   [ Time Frame: Schedule 1: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, 24.0, 48 or 72, 72 or 96 and 168 hours post-dose during Week 1; Schedule 2: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, and 24.0 hours post-dose on Day 1. ]

12.  Secondary:   Apparent Volume of Distribution Associated to the Terminal Phase (Vz/f)   [ Time Frame: Schedule 1: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, 24.0, 48 or 72, 72 or 96 and 168 hours post-dose during Week 1; Schedule 2: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, and 24.0 hours post-dose on Day 1. ]

13.  Secondary:   Extracellular Signal-regulated Kinase (ERK) Phosphorylation Levels   [ Time Frame: Schedule 1: Day 1: Pre-dose; Post-dose: 2, 4, 8, 24 hour; 48 or 72 hour; 48 or 96 hour, 168 hour; Day 15: Pre-dose; Schedule 2: Day 1: Pre-dose; Post-dose: 2, 8, 24, 48, 96 hour; Day 15: Pre-dose; Day 17: Pre-dose; Post-dose: 2, 8, and 24 hour ]

14.  Secondary:   Percentage of Subjects With Overall Response   [ Time Frame: Every 6 Weeks until complete response or till data cut-off date 15 July 2013 ]

15.  Secondary:   Percentage of Subjects With Clinical Benefit   [ Time Frame: Every 6 Weeks until complete response or till data cut-off date 15 July 2013 ]


  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
The study was terminated early during Part 1 of the trial due to administrative reason. Pharmacodynamics evaluations were not performed due to early termination.


  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 Serono, a division of Merck KGaA
phone: +49-6151-72-5200
e-mail: service@merckgroup.com



Responsible Party: EMD Serono
ClinicalTrials.gov Identifier: NCT01453387     History of Changes
Other Study ID Numbers: EMR 200064-001
Study First Received: September 9, 2011
Results First Received: April 8, 2016
Last Updated: March 27, 2017