Phase II Trial Of ZK-EPO (ZK 219477) (Sagopilone) In Metastatic Melanoma

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT00598507
First received: January 10, 2008
Last updated: November 15, 2013
Last verified: August 2013
Results First Received: September 12, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Melanoma
Intervention: Drug: ZK-EPO

  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
Accrual began in May 2007 at Moffitt Cancer Center and was completed in October 2008.

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
Chemotherapy - ZK-EPO ZK-EPO (ZK 219477) (Sagopilone), 16 mg/m^2, was administered intravenously over 3-hours every 21 days until progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Chemotherapy - ZK-EPO  
STARTED     35  
COMPLETED     35  
NOT COMPLETED     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.
Participants treated with at least one dose of sagopilone.

Reporting Groups
  Description
Chemotherapy - ZK-EPO ZK-EPO (ZK 219477) (Sagopilone), 16 mg/m^2, was administered intravenously over 3-hours every 21 days until progression or unacceptable toxicity.

Baseline Measures
    Chemotherapy - ZK-EPO  
Number of Participants  
[units: participants]
  35  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     12  
>=65 years     23  
Age  
[units: years]
Median ± Standard Deviation
  68.7  ± 1.7  
Gender  
[units: participants]
 
Female     11  
Male     24  
Region of Enrollment  
[units: participants]
 
United States     35  



  Outcome Measures
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1.  Primary:   Response Rate (RR)   [ Time Frame: Up to 5 years ]

2.  Secondary:   Median Progression Free Survival (PFS)   [ Time Frame: Up to 5 years ]

3.  Secondary:   Median Overall Survival (OS)   [ Time Frame: Up to 5 years ]

4.  Secondary:   Occurrence of Attributable Serious Adverse Events (SAEs)   [ Time Frame: Up to 5 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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Ronald DeConti, M.D., Principal Investigator
Organization: H. Lee Moffitt Cancer Center and Research Institute
phone: 813-745-8466
e-mail: ronald.deconti@moffitt.org


No publications provided


Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00598507     History of Changes
Other Study ID Numbers: MCC-14965, ZK219477, 108.0701
Study First Received: January 10, 2008
Results First Received: September 12, 2013
Last Updated: November 15, 2013
Health Authority: United States: Institutional Review Board