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Trial record 1 of 1 for:    TH-CR-404
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Study of the Safety and Efficacy of TH-302 in Combination With Gemcitabine Compared With Gemcitabine Alone in Previously Untreated Patients With Pancreatic Adenocarcinoma

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ClinicalTrials.gov Identifier: NCT01144455
Recruitment Status : Completed
First Posted : June 15, 2010
Results First Posted : October 25, 2017
Last Update Posted : December 19, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Pancreatic Adenocarcinoma
Interventions: Drug: Gemzar (Gemcitabine)
Drug: TH-302

  Participant Flow

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
No text entered.

Reporting Groups
  Description
Gemcitabine

Gemcitabine: 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle

Gemzar (Gemcitabine): 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle.

240 mg/m2 TH-302 + Gemcitabine

TH-302: 240 mg/m2 administered IV over 30 minutes Day 1, 8, and 15 of each 28-day cycle

Gemcitabine: 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle

Gemzar (Gemcitabine): 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle.

TH-302: 240 mg/m2 of TH-302 will be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle.

340 mg/m2 TH-302 + Gemcitabine

TH-302: 340 mg/m2 of TH-302 be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle.

Gemcitabine: 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle

Gemzar (Gemcitabine): 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle.

TH-302: 340 mg/m2 of TH-302 will be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle.


Participant Flow:   Overall Study
    Gemcitabine   240 mg/m2 TH-302 + Gemcitabine   340 mg/m2 TH-302 + Gemcitabine
STARTED   69   71   74 
COMPLETED   19   29   38 
NOT COMPLETED   50   42   36 



  Baseline Characteristics

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
Gemcitabine

Gemcitabine: 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle

Gemzar (Gemcitabine): 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle.

240 mg/m2 TH-302 + Gemcitabine

TH-302: 240 mg/m2 administered IV over 30 minutes Day 1, 8, and 15 of each 28-day cycle

Gemcitabine: 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle

Gemzar (Gemcitabine): 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle.

TH-302: 240 mg/m2 of TH-302 will be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle.

340 mg/m2 TH-302 + Gemcitabine

TH-302: 340 mg/m2 of TH-302 be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle.

Gemcitabine: 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle

Gemzar (Gemcitabine): 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle.

TH-302: 340 mg/m2 of TH-302 will be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle.

Total Total of all reporting groups

Baseline Measures
   Gemcitabine   240 mg/m2 TH-302 + Gemcitabine   340 mg/m2 TH-302 + Gemcitabine   Total 
Overall Participants Analyzed 
[Units: Participants]
 69   71   74   214 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      28  40.6%      43  60.6%      36  48.6%      107  50.0% 
>=65 years      41  59.4%      28  39.4%      38  51.4%      107  50.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      29  42.0%      27  38.0%      32  43.2%      88  41.1% 
Male      40  58.0%      44  62.0%      42  56.8%      126  58.9% 
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% 
Asian      4   5.8%      0   0.0%      1   1.4%      5   2.3% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      3   4.3%      4   5.6%      5   6.8%      12   5.6% 
White      62  89.9%      64  90.1%      67  90.5%      193  90.2% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      3   4.2%      1   1.4%      4   1.9% 


  Outcome Measures

1.  Primary:   Progression-free Survival (PFS)   [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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


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

Responsible Party: Threshold Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01144455     History of Changes
Other Study ID Numbers: TH-CR-404
First Submitted: June 11, 2010
First Posted: June 15, 2010
Results First Submitted: July 17, 2017
Results First Posted: October 25, 2017
Last Update Posted: December 19, 2017