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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 has been completed.
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: February 27, 2017
Last verified: February 2017
Results First Received: October 26, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   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 
Overall Participants Analyzed 
[Units: Participants]
 0   6   3   17   1   27 
Age 
[Units: Participants]
Count of Participants
           
<=18 years         0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years         2  33.3%      3 100.0%      12  70.6%      0   0.0%      17  63.0% 
>=65 years         4  66.7%      0   0.0%      5  29.4%      1 100.0%      10  37.0% 
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) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
           
Female         1  16.7%      1  33.3%      4  23.5%      1 100.0%      7  25.9% 
Male         5  83.3%      2  66.7%      13  76.5%      0   0.0%      20  74.1% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
           
Hispanic or Latino         1  16.7%      0   0.0%      1   5.9%      0   0.0%      2   7.4% 
Not Hispanic or Latino         5  83.3%      3 100.0%      16  94.1%      1 100.0%      25  92.6% 
Unknown or Not Reported         0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
           
American Indian or Alaska Native         0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian         0   0.0%      0   0.0%      0   0.0%      1 100.0%      1   3.7% 
Native Hawaiian or Other Pacific Islander         0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American         0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
White         5  83.3%      3 100.0%      17 100.0%      0   0.0%      25  92.6% 
More than one race         0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported         1  16.7%      0   0.0%      0   0.0%      0   0.0%      1   3.7% 
Region of Enrollment 
[Units: Participants]
Count of 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: 4 years, 6 months and 26 days ]

5.  Secondary:   Number of Participants Who Underwent Medically-Necessary Interventions   [ Time Frame: 4.5 years ]

6.  Secondary:   Tumor Growth Rate Constant   [ Time Frame: 21 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: 301-480-7164
e-mail: gulleyj@mail.nih.gov


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

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: February 27, 2017