Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Stage IV Melanoma

This study has been terminated.
(Administratively complete.)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01120275
First received: May 7, 2010
Last updated: May 6, 2016
Last verified: May 2016
Results First Received: October 29, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Acral Lentiginous Malignant Melanoma
Lentigo Maligna Malignant Melanoma
Nodular Malignant Melanoma
Recurrent Melanoma
Solar Radiation-related Skin Melanoma
Stage IV Melanoma
Superficial Spreading Malignant Melanoma
Interventions: Drug: gamma-secretase/Notch signalling pathway inhibitor RO4929097
Other: laboratory biomarker analysis

  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
No text entered.

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
Treatment (Gamma-secretase Inhibitor RO4929097)

Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO

laboratory biomarker analysis: Correlative studies


Participant Flow:   Overall Study
    Treatment (Gamma-secretase Inhibitor RO4929097)  
STARTED     36  
Eligible and Treated     32  
COMPLETED     0  
NOT COMPLETED     36  
Adverse Event                 3  
Progression                 27  
Ineligible                 3  
Withdrawal by Subject                 1  
Refusal                 1  
Not specific                 1  



  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.
Eligible patients who had received the protocol treatments were included in the baseline analysis.

Reporting Groups
  Description
Treatment (Gamma-secretase Inhibitor RO4929097)

Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO

laboratory biomarker analysis: Correlative studies


Baseline Measures
    Treatment (Gamma-secretase Inhibitor RO4929097)  
Number of Participants  
[units: participants]
  32  
Age  
[units: years]
Median (Full Range)
  60.9  
  (32.8 to 85.9)  
Gender  
[units: participants]
 
Female     10  
Male     22  
Performance Status [1]
[units: participants]
 
0     24  
1     8  
Primary Type  
[units: participants]
 
Cutaneous     22  
Unknown primary     10  
Site(s) of Metastases [2]
[units: participants]
 
Bone     8  
Liver     12  
Lymph node, skin, soft tissue     17  
Lung     17  
Other non-visceral     1  
Other visceral     9  
Elevated Lactate Dehydrogenase (LDH)  
[units: participants]
 
No     19  
Yes     13  
[1] Patients were graded according to the Zubrod Performance Status Scale. Performance Status is 0 if patient is fully active, able to carry on all pre-disease performance without restriction. Performance Status is 1 if patient is restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work.
[2] Distant metastatic involvement is defined as the presence of one or more metastases beyond the regional lymph node drainage.



  Outcome Measures
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1.  Primary:   Progression-free Survival According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1   [ Time Frame: Disease assessments were performed every 6 weeks, up to 3 years. ]

2.  Primary:   Overall Survival   [ Time Frame: Weekly, up to 3 years. ]

3.  Secondary:   Percentage of Participants With Confirmed and Unconfirmed Complete or Partial Response   [ Time Frame: Disease assessments for response were performed every 6 weeks, up to 3 years ]

4.  Secondary:   Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs   [ Time Frame: Toxicity assessment was evaluated at least every 3 weeks at the beginning of each cycle, up to 3 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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  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Melanoma Committee Statistician
Organization: SWOG Statistical Center
phone: 2066674623
e-mail: jmoon@fredhutch.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01120275     History of Changes
Other Study ID Numbers: NCI-2011-02040
NCI-2011-02040 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
SWOG-S0933
CDR0000671815
S0933 ( Other Identifier: SWOG )
S0933 ( Other Identifier: CTEP )
U10CA032102 ( US NIH Grant/Contract Award Number )
Study First Received: May 7, 2010
Results First Received: October 29, 2015
Last Updated: May 6, 2016
Health Authority: United States: Food and Drug Administration