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Phase II Trial of Pimasertib Versus Dacarbazine in N-Ras Mutated Cutaneous Melanoma

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ClinicalTrials.gov Identifier: NCT01693068
Recruitment Status : Completed
First Posted : September 26, 2012
Results First Posted : January 5, 2018
Last Update Posted : January 5, 2018
Sponsor:
Collaborator:
Merck KGaA
Information provided by (Responsible Party):
EMD Serono

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: N-Ras Mutated Locally Advanced or Metastasis Malignant Cutaneous Melanoma
Interventions: Drug: Pimasertib
Drug: Dacarbazine

  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/last subject (informed consent): 05 December 2012/04 June 2014. Cut-off date: 04 July 2015. Last subject last visit: 24 October 2016.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 194 subjects were randomized in trial. Data presented based on the cut-off date of 04 July 2015.

Reporting Groups
  Description
Dacarbazine Subjects received dacarbazine intravenously at dose of 1000 mg/m^2 of body surface area every 3 weeks on Day 1 of each 21-days cycle until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first. Eligible subjects with documented tumor progression on dacarbazine were offered to switch to pimasertib treatment.
Pimasertib Subjects received pimasertib orally as monotherapy at a dose of 60 milligram (mg) twice daily continuously. Treatment consisted of repeated 21-day cycles which was continued until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first.
Pimasertib (Crossover) Subjects who were randomized and received dacarbazine and were allowed to crossover to pimasertib treatment on progression of their disease.

Participant Flow for 2 periods

Period 1:   Randomization Period
    Dacarbazine   Pimasertib   Pimasertib (Crossover)
STARTED   64   130   0 
Treated   61   130   0 
COMPLETED   62   125   0 
NOT COMPLETED   2   5   0 
On-study                2                5                0 

Period 2:   Cross-over (Dacarbazine To Pimasertib)
    Dacarbazine   Pimasertib   Pimasertib (Crossover)
STARTED   0   0   41 
Treated   0   0   41 
COMPLETED   0   0   40 
NOT COMPLETED   0   0   1 
On-study                0                0                1 



  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.
Intent-to-treat (ITT) analysis set included all subjects who were randomized to trial treatment.

Reporting Groups
  Description
Dacarbazine Subjects received dacarbazine intravenously at dose of 1000 mg/m^2 of body surface area every 3 weeks on Day 1 of each 21-days cycle until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first. Eligible subjects with documented tumor progression on dacarbazine were offered to switch to pimasertib treatment.
Pimasertib Subjects received pimasertib orally as monotherapy at a dose of 60 mg twice daily continuously. Treatment consisted of repeated 21-day cycles which was continued until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first.
Total Total of all reporting groups

Baseline Measures
   Dacarbazine   Pimasertib   Total 
Overall Participants Analyzed 
[Units: Participants]
 64   130   194 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      36  56.3%      65  50.0%      101  52.1% 
>=65 years      28  43.8%      65  50.0%      93  47.9% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      28  43.8%      62  47.7%      90  46.4% 
Male      36  56.3%      68  52.3%      104  53.6% 


  Outcome Measures

1.  Primary:   Progression Free Survival (PFS)   [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to cut-off date (04-Jul-2015) ]

2.  Secondary:   Objective Response Rate (ORR)   [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to cut-off date (04-Jul-2015) ]

3.  Secondary:   Disease Control Rate (DCR)   [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to cut-off date (04-Jul-2015) ]

4.  Secondary:   Percentage of Subjects With Progression-free Survival (PFS) at 6 Months   [ Time Frame: 6 months ]

5.  Secondary:   Overall Survival (OS)   [ Time Frame: From date of randomization until date of death from any cause, assessed up to cut-off date (04-Jul-2015) ]

6.  Secondary:   Percentage of Subjects With Overall Survival (OS) at 12 Months   [ Time Frame: 12 months ]

7.  Secondary:   Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Total Score (FACT-M TS) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)   [ Time Frame: Baseline, Day 1 of Cycle 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 30, 31, 32, 33, 35, 36, 37 and EOT (up to cut-off date [04-Jul-2015]) ]

8.  Secondary:   Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Trial Outcome Index (FACT-M TOI) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)   [ Time Frame: Baseline, Day 1 of Cycle 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 30, 31, 32, 33, 35, 36, 37 and EOT (up to cut-off date [04-Jul-2015]) ]

9.  Secondary:   Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation or TEAEs Leading to Death   [ Time Frame: Baseline up to cut-off date (04-Jul-2015) ]

10.  Secondary:   Number of Subjects With Adverse Events (AEs) of Special Interest   [ Time Frame: Baseline up to cut-off date (04-Jul-2015) ]

11.  Secondary:   Number of Subjects With Clinically Significant Change From Baseline in Laboratory Parameter, Vital Signs, Electrocardiogram (ECG) and Ophthalmologic Findings   [ Time Frame: Baseline up to cut-off date (04-Jul-2015) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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: NCT01693068     History of Changes
Other Study ID Numbers: EMR 200066-007
2012-002669-37 ( EudraCT Number )
First Submitted: September 14, 2012
First Posted: September 26, 2012
Results First Submitted: October 23, 2017
Results First Posted: January 5, 2018
Last Update Posted: January 5, 2018