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Study of Combretastatin and Paclitaxel/Carboplatin in the Treatment of Anaplastic Thyroid Cancer (FACT)

This study has been terminated.
(Low rate of subject accrual)
Sponsor:
Information provided by (Responsible Party):
Mateon Therapeutics
ClinicalTrials.gov Identifier:
NCT00507429
First received: July 25, 2007
Last updated: May 12, 2014
Last verified: February 2014
Results First Received: August 16, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Anaplastic Thyroid Cancer
Interventions: Drug: CA4P
Drug: paclitaxel
Drug: carboplatin

  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
Study truncated from 180 to 80 subjects. Subjects were enrolled from August 2007 through March 2010 at 40 worldwide, academic and local-regional clinical sites.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
During screening, the diagnosis of anaplastic thyroid cancer was centrally confirmed often leading to enrollment and randomization delays.

Reporting Groups
  Description
Arm 1, Active: CA4P + Carboplatin + Paclitaxel Randomized 2:1 to receive six 21-day cycles of CA4P (60mg/m2)on days 1, 8, 15 + carboplatin (AUC 6) + paclitaxel (200 mg/m2) on Day 2. Subjects without progressive disease may continue maintenance CA4P infusions until progressive disease, then followed monthly for survival.
Arm 2, Control: Carboplatin + Paclitaxel On Day 2 of six 21-cycles subjects received Carboplatin (AUC 6) + paclitaxel (200 mg/m2). Subjects without progressive disease were followed monthly for survival.

Participant Flow for 2 periods

Period 1:   Treatment Phase
    Arm 1, Active: CA4P + Carboplatin + Paclitaxel   Arm 2, Control: Carboplatin + Paclitaxel
STARTED   55 [1]   25 [1] 
COMPLETED   18   7 
NOT COMPLETED   37   18 
Disease Progression                12                5 
Adverse Event                12                5 
Withdrawal by Subject                3                3 
Physician Decision                4                2 
Other                6                3 
[1] Randomized

Period 2:   Maintenance Phase
    Arm 1, Active: CA4P + Carboplatin + Paclitaxel   Arm 2, Control: Carboplatin + Paclitaxel
STARTED   16 [1]   0 [2] 
COMPLETED   2 [3]   0 
NOT COMPLETED   14   0 
Progressive Disease                14                0 
[1] 2 subjects did not enter maintenance: 1/18 progressive disease; 1/18 lost to follow-up.
[2] Control arm subjects followed for survival only; not enrolled in Maintenance period
[3] 14 subjects were withdrawn due to progressive disease, 2 subjects continued beyond data cut-off



  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
Arm 1, Active: CA4P + Carboplatin + Paclitaxel Randomized 2:1 to receive six 21-day cycles of CA4P (60mg/m2)on days 1, 8, 15 + carboplatin (AUC 6) + paclitaxel (200 mg/m2) on Day 2. Subjects without progressive disease may continue maintenance CA4P infusions until progressive disease, then followed monthly for survival.
Arm 2, Control: Carboplatin + Paclitaxel On Day 2 of six 21-cycles subjects received Carboplatin (AUC 6) + paclitaxel (200 mg/m2). Subjects without progressive disease were followed monthly for survival.
Total Total of all reporting groups

Baseline Measures
   Arm 1, Active: CA4P + Carboplatin + Paclitaxel   Arm 2, Control: Carboplatin + Paclitaxel   Total 
Overall Participants Analyzed 
[Units: Participants]
 55   25   80 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   29   14   43 
>=65 years   26   11   37 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.5  (10.72)   61.2  (10.54)   61.4  (10.60) 
Gender 
[Units: Participants]
     
Female   25   18   43 
Male   30   7   37 
Region of Enrollment 
[Units: Participants]
     
Belarus   1   1   2 
United States   20   5   25 
Poland   5   1   6 
Ukraine   1   1   2 
Romania   1   0   1 
Russian Federation   2   1   3 
Bulgaria   3   0   3 
Israel   2   1   3 
Italy   13   8   21 
United Kingdom   2   1   3 
India   5   6   11 


  Outcome Measures
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1.  Primary:   Overall Survival   [ Time Frame: From randomization to date last known alive ]

2.  Secondary:   To Determine Percentage of 1 Year Survival   [ Time Frame: from randomization through end of study visit ]

3.  Secondary:   To Determine Progression Free Survival   [ Time Frame: from randomization through end of study visit ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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 study was to enroll 180 subjects. Enrollment was terminated early due to low accrual rate. Eighty subjects were enrolled.


  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: Peter Langecker, MD, PhD
Organization: OXiGENE, Inc.
phone: 650 635 7008
e-mail: plangecker@oxigene.com


Publications:

Responsible Party: Mateon Therapeutics
ClinicalTrials.gov Identifier: NCT00507429     History of Changes
Other Study ID Numbers: OXC4T4-302
Study First Received: July 25, 2007
Results First Received: August 16, 2013
Last Updated: May 12, 2014