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A Phase Ib Expansion Study Investigating the Safety, Efficacy, and Pharmacokinetics of Intravenous CUDC-101 in Subjects With Advanced Head and Neck, Gastric, Breast, Liver and Non-small Cell Lung Cancer Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Curis, Inc.
ClinicalTrials.gov Identifier:
NCT01171924
First received: July 27, 2010
Last updated: February 1, 2016
Last verified: February 2016
Results First Received: April 23, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Head and Neck Cancer
Liver Cancer
Breast Cancer
Gastric Cancer
Non-Small Cell Lung Cancer
Intervention: Drug: CUDC-101

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Arm A: 5 Days/Week Schedule CUDC-101: CUDC-101 administered as a 1 hour intravenous infusion at the maximum tolerated dose of 275 mg/m2 consecutively for 5 days on each 14 day cycle.
Arm B: 3 Days/Week Schedule CUDC-101: CUDC-101 administered as a 1 hour intravenous infusion at the maximum tolerated dose of 275 mg/m2 on Monday, Wednesday, Friday for three consecutive weeks of each 28 day cycle.

Participant Flow:   Overall Study
    Arm A: 5 Days/Week Schedule     Arm B: 3 Days/Week Schedule  
STARTED     23     23  
COMPLETED     0     0  
NOT COMPLETED     23     23  



  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.
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Reporting Groups
  Description
Arm A: 5 Days/Week Schedule CUDC-101: CUDC-101 administered as a 1 hour intravenous infusion at the maximum tolerated dose of 275 mg/m2 consecutively for 5 days on each 14 day cycle.
Arm B: 3 Days/Week Schedule CUDC-101: CUDC-101 administered as a 1 hour intravenous infusion at the maximum tolerated dose of 275 mg/m2 on Monday, Wednesday, Friday for three consecutive weeks of each 28 day cycle.
Total Total of all reporting groups

Baseline Measures
    Arm A: 5 Days/Week Schedule     Arm B: 3 Days/Week Schedule     Total  
Number of Participants  
[units: participants]
  23     23     46  
Age  
[units: years]
Median (Full Range)
  61.0  
  (40.0 to 78.0)  
  65.0  
  (37.0 to 85.0)  
  63.0  
  (37.0 to 85.0)  
Gender  
[units: participants]
     
Female     10     11     21  
Male     13     12     25  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     1     4     5  
Not Hispanic or Latino     22     18     40  
Unknown or Not Reported     0     1     1  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     3     3     6  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     2     4     6  
White     18     13     31  
More than one race     0     0     0  
Unknown or Not Reported     0     3     3  
Region of Enrollment  
[units: participants]
     
United States     23     23     46  



  Outcome Measures

1.  Primary:   Number of Participants With Adverse Events   [ Time Frame: 12-15 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
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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 NOT 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.


Results Point of Contact:  
Name/Title: Associate Director of Regulatory Affairs
Organization: Curis, Inc.
phone: (617) 503-6548
e-mail: lsaunders@curis.com


Publications:

Responsible Party: Curis, Inc.
ClinicalTrials.gov Identifier: NCT01171924     History of Changes
Other Study ID Numbers: CUDC-101-102
Study First Received: July 27, 2010
Results First Received: April 23, 2015
Last Updated: February 1, 2016
Health Authority: United States: Food and Drug Administration