A Phase I/II Trial of Crolibulin (EPC2407) Plus Cisplatin in Adults With Solid Tumors With a Focus on Anaplastic Thyroid Cancer (ATC)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
James Gulley, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01240590
First received: November 11, 2010
Last updated: November 27, 2015
Last verified: November 2015
Results First Received: October 26, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Solid Tumor
Anaplastic Thyroid Cancer
Interventions: Drug: Crolibulin
Drug: Cisplatin

  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
The phase II portion was not completed because it was impossible to recruit.

Reporting Groups
  Description
Level -1: Cisplatin + Crolibulin 75mg/m(2) Cisplatin + 8 mg/m(2) Crolibulin Drug: Crolibulin Phase I:Dose Level (DL) 1 - 13 mg/m(2) intravenous (IV),DL 2 - 13 mg/m(2) IV, DL 3 - 20 mg/m(2) IV. Phase II: 20 mg/m(2) Drug: Cisplatin Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)
Level 1: Cisplatin + Crolibulin 75mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin Drug: Crolibulin Phase I:Dose Level (DL) 1 - 13 mg/m(2) intravenous (IV),DL 2 - 13 mg/m(2) IV, DL 3 - 20 mg/m(2) IV. Phase II: 20 mg/m(2) Drug: Cisplatin Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)
Level 2: Cisplatin + Crolibulin 100mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin Drug: Crolibulin Phase I:Dose Level (DL) 1 - 13 mg/m(2) intravenous (IV),DL 2 - 13 mg/m(2) IV, DL 3 - 20 mg/m(2) IV. Phase II: 20 mg/m(2) Drug: Cisplatin Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)
Level 3: Cisplatin + Crolibulin 100mg/m(2) Cisplatin + 20 mg/m(2) Crolibulin Drug: Crolibulin Phase I:Dose Level (DL) 1 - 13 mg/m(2) intravenous (IV),DL 2 - 13 mg/m(2) IV, DL 3 - 20 mg/m(2) IV. Phase II: 20 mg/m(2) Drug: Cisplatin Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)
Level 4: Cisplatin 100mg/m(2) Cisplatin Drug: Cisplatin Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)

Participant Flow for 2 periods

Period 1:   Phase I
    Level -1: Cisplatin + Crolibulin     Level 1: Cisplatin + Crolibulin     Level 2: Cisplatin + Crolibulin     Level 3: Cisplatin + Crolibulin     Level 4: Cisplatin  
STARTED     0     6     3     0     0  
COMPLETED     0     6     0     0     0  
NOT COMPLETED     0     0     3     0     0  
Refused further treatment                 0                 0                 3                 0                 0  

Period 2:   Phase II
    Level -1: Cisplatin + Crolibulin     Level 1: Cisplatin + Crolibulin     Level 2: Cisplatin + Crolibulin     Level 3: Cisplatin + Crolibulin     Level 4: Cisplatin  
STARTED     0     0     0     17     1  
COMPLETED     0     0     0     15     0  
NOT COMPLETED     0     0     0     2     1  
Refused further treatment                 0                 0                 0                 2                 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.
No text entered.

Reporting Groups
  Description
Ph I Level -1: Cisplatin + Crolibulin 75mg/m(2) Cisplatin + 8 mg/m(2) Crolibulin
Ph I Level 1: Cisplatin + Crolibulin 75mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin
Ph I Level 2: Cisplatin + Crolibulin 100mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin
Ph II Level 3: Cisplatin + Crolibulin 100mg/m(2) Cisplatin + 20 mg/m(2) Crolibulin
Ph II Level 4: Cisplatin 100mg/m(2) Cisplatin
Total Total of all reporting groups

Baseline Measures
    Ph I Level -1: Cisplatin + Crolibulin     Ph I Level 1: Cisplatin + Crolibulin     Ph I Level 2: Cisplatin + Crolibulin     Ph II Level 3: Cisplatin + Crolibulin     Ph II Level 4: Cisplatin     Total  
Number of Participants  
[units: participants]
  0     6     3     17     1     27  
Age  
[units: participants]
           
<=18 years         0     0     0     0     0  
Between 18 and 65 years         2     3     12     0     17  
>=65 years         4     0     5     1     10  
Age  
[units: years]
Mean (Standard Deviation)
      68.03  (8.09)     51.53  (7.45)     58.76  (8.44)     70.3  (0)     60.45  (9.42)  
Gender  
[units: participants]
           
Female         5     1     4     1     11  
Male         1     2     13     0     16  
Ethnicity (NIH/OMB)  
[units: participants]
           
Hispanic or Latino         1     0     1     0     2  
Not Hispanic or Latino         5     3     16     1     25  
Unknown or Not Reported         0     0     0     0     0  
Race (NIH/OMB)  
[units: participants]
           
American Indian or Alaska Native         0     0     0     0     0  
Asian         0     0     0     1     1  
Native Hawaiian or Other Pacific Islander         0     0     0     0     0  
Black or African American         0     0     0     0     0  
White         5     3     17     0     25  
More than one race         0     0     0     0     0  
Unknown or Not Reported         1     0     0     0     1  
Region of Enrollment  
[units: participants]
           
United States         6     3     17     1     27  



  Outcome Measures
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1.  Primary:   Maximum Tolerated Dose (MTD) of Cisplatin (Phase I)   [ Time Frame: 3 weeks ]

2.  Primary:   Maximum Tolerated Dose (MTD) of Crolibulin (Phase I)   [ Time Frame: 3 weeks ]

3.  Primary:   Progression Free Survival (Phase II)   [ Time Frame: 6 weeks ]

4.  Primary:   Number of Participants With Serious and Non-Serious Adverse Events (Phase I & II)   [ Time Frame: 34 months and 10 days ]


  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
The phase II portion was not completed because it was impossible to recruit.


  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: Dr. James Gulley
Organization: National Cancer Institute
phone: 301-496-4916
e-mail: gulleyj@mail.nih.gov


Publications:

Responsible Party: James Gulley, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01240590     History of Changes
Other Study ID Numbers: 110027
11-C-0027
Study First Received: November 11, 2010
Results First Received: October 26, 2015
Last Updated: November 27, 2015
Health Authority: United States: Federal Government
United States: Food and Drug Administration