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Dose-Escalation Study of TH-302 in Combination With Doxorubicin to Treat Patients With Advanced Soft Tissue Sarcoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00742963
First Posted: August 28, 2008
Last Update Posted: October 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Threshold Pharmaceuticals
Results First Submitted: July 14, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Soft Tissue Sarcoma
Intervention: Drug: TH-302

  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
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Reporting Groups
  Description
TH-302 in Combination With Doxorubicin

75 mg/m2 of Doxorubicin administered by bolus injection starting on Day 1 of a 21-day cycle.

TH-302: TH-302 will be administered by IV infusion over 30-60 minutes on Days 1 and 8 of a 21-day cycle.

Dose escalation dose levels:

Dose level -1 (if needed): 180 mg/m2 Starting dose: 240 mg/m2


Participant Flow:   Overall Study
    TH-302 in Combination With Doxorubicin
STARTED   101 
Completed All Treatment Cycles   68 
COMPLETED   68 
NOT COMPLETED   33 



  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.
107 enrolled, 101 dosed.

Reporting Groups
  Description
TH-302 in Combination With Doxorubicin

75 mg/m2 of Doxorubicin administered by bolus injection starting on Day 1 of a 21-day cycle.

TH-302: TH-302 will be administered by IV infusion over 30-60 minutes on Days 1 and 8 of a 21-day cycle.

Dose escalation dose levels:

Dose level -1 (if needed): 180 mg/m2 Starting dose: 240 mg/m2


Baseline Measures
   TH-302 in Combination With Doxorubicin 
Overall Participants Analyzed 
[Units: Participants]
 101 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      77  76.2% 
>=65 years      24  23.8% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      58  57.4% 
Male      43  42.6% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      7   6.9% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      7   6.9% 
White      86  85.1% 
More than one race      0   0.0% 
Unknown or Not Reported      1   1.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   101 


  Outcome Measures

1.  Primary:   Maximum Tolerated Dose (MTD) Measured of TH-302 When Used in Combination With Doxorubicin and Prophylactic Growth Factor Support in Subjects With Advanced Soft Tissue Sarcoma   [ Time Frame: Two 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:  
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: Thomas Wilson
Organization: Threshold Pharmaceuticals
phone: 302-359-0565
e-mail: twilson@thresholdpharm.com



Responsible Party: Threshold Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00742963     History of Changes
Other Study ID Numbers: TH-CR-403
First Submitted: August 26, 2008
First Posted: August 28, 2008
Results First Submitted: July 14, 2017
Results First Posted: September 22, 2017
Last Update Posted: October 26, 2017