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Dinaciclib in Treating Patients With Stage III-IV Melanoma

This study has been terminated.
(slow accrual)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01026324
First received: December 3, 2009
Last updated: June 22, 2016
Last verified: June 2016
Results First Received: February 9, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Stage IIIB Melanoma
Stage IIIC Melanoma
Stage IV Melanoma
Interventions: Drug: dinaciclib
Other: pharmacological study
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
Subjects were screened and enrolled at one site in the US, Dana Farber Cancer Institute.

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 (Dinaciclib) Dose Level 1

Patients receive dinaciclib at Dose Level 1 (10 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.

dinaciclib: Given IV

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

Treatment (Dinaciclib) Dose Level 2

Patients receive dinaciclib at Dose Level 2 (20 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.

dinaciclib: Given IV

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

Treatment (Dinaciclib) Dose Level 3

Patients receive dinaciclib at Dose Level 3(30 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.

dinaciclib: Given IV

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies


Participant Flow for 2 periods

Period 1:   Treatment Allocation
    Treatment (Dinaciclib) Dose Level 1     Treatment (Dinaciclib) Dose Level 2     Treatment (Dinaciclib) Dose Level 3  
STARTED     5     3     4  
Discontinued Intervention (Toxicity)     1     0     0  
Discontinuted Intervention (Progression)     3     3     4  
Discontinued Intervention (Withdrew)     1     0     0  
COMPLETED     5     3     4  
NOT COMPLETED     0     0     0  

Period 2:   Follow up/Survival
    Treatment (Dinaciclib) Dose Level 1     Treatment (Dinaciclib) Dose Level 2     Treatment (Dinaciclib) Dose Level 3  
STARTED     5     3     4  
Follow up Discontinuation (Death)     4     3     4  
COMPLETED     4     3     4  
NOT COMPLETED     1     0     0  
Withdrawal by Subject                 1                 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.
No text entered.

Reporting Groups
  Description
Treatment (Dinaciclib) Dose Level 1

Patients receive dinaciclib at Dose Level 1 (10 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.

dinaciclib: Given IV pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies

Treatment (Dinaciclib) Dose Level 2

Patients receive dinaciclib at Dose Level 2 (20 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.

dinaciclib: Given IV pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies

Treatment (Dinaciclib) Dose Level 3

Patients receive dinaciclib at Dose Level 3 (30 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.

dinaciclib: Given IV pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies

Total Total of all reporting groups

Baseline Measures
    Treatment (Dinaciclib) Dose Level 1     Treatment (Dinaciclib) Dose Level 2     Treatment (Dinaciclib) Dose Level 3     Total  
Number of Participants  
[units: participants]
  5     3     4     12  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     4     2     4     10  
>=65 years     1     1     0     2  
Gender  
[units: participants]
       
Female     2     2     1     5  
Male     3     1     3     7  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Recommended Phase-2 Dose of SCH727965   [ Time Frame: 14 days ]

2.  Primary:   Percentage of Patients Alive (Phase II)   [ Time Frame: Up to 1 year ]

3.  Secondary:   Progression-free Survival   [ Time Frame: Up to 6 months ]


  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
No text entered.


  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: F. Stephen Hodi, MD
Organization: Dana-Farber Cancer Institute
phone: 617-632-5053
e-mail: stephen_hodi@dfci.harvard.edu



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01026324     History of Changes
Other Study ID Numbers: NCI-2013-00522
NCI-2013-00522 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
09-152 ( Other Identifier: Dana-Farber Cancer Institute )
8296 ( Other Identifier: CTEP )
U01CA062490 ( US NIH Grant/Contract Award Number )
P30CA006516 ( US NIH Grant/Contract Award Number )
Study First Received: December 3, 2009
Results First Received: February 9, 2016
Last Updated: June 22, 2016
Health Authority: United States: Food and Drug Administration