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Dose Escalation, Combination Chemotherapy Safety Study of Birinapant (TL32711), in Subjects With Advanced or Metastatic Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
TetraLogic Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01188499
First received: August 23, 2010
Last updated: April 21, 2016
Last verified: April 2016
Results First Received: April 21, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Cancer
Intervention: Drug: Birinapant

  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
No text entered.

Reporting Groups
  Description
Arm 1: Carboplatin/Paclitaxel + Birinapant

Carboplatin (AUC 6/Paclitaxel (175 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).

TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy

Arm 2: Irinotecan + Birinapant

Irinotecan (350 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).

TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy

Arm 3: Docetaxel + Birinapant

Docetaxel (75 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).

TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy

Arm 4: Gemcitabine + Birinapant

Gemcitabine (1000 mg/m2/IV) once weekly (7 days +/- 2 days) for 3 consecutive weeks followed by 1 week off + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 2 week off for each cycle (4 weeks per cycle).

TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by two weeks off repeated every 4 weeks as tolerated in combination with chemotherapy.

Arm 5: Liposomal Doxorubicin + Birinapant

Liposomal doxorubicin (40 mg/m2/IV) every 4 weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 2 weeks off for each cycle (4 weeks per cycle).

TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by two weeks off repeated every 4 weeks as tolerated in combination with chemotherapy.


Participant Flow:   Overall Study
    Arm 1: Carboplatin/Paclitaxel + Birinapant   Arm 2: Irinotecan + Birinapant   Arm 3: Docetaxel + Birinapant   Arm 4: Gemcitabine + Birinapant   Arm 5: Liposomal Doxorubicin + Birinapant
STARTED   24   83   33   18   18 
COMPLETED   24   83   33   18   18 
NOT COMPLETED   0   0   0   0   0 



  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: Carboplatin/Paclitaxel + Birinapant

Carboplatin (AUC 6/Paclitaxel (175 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).

TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy

Arm 2: Irinotecan + Birinapant

Irinotecan (350 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).

TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy

Arm 3: Docetaxel + Birinapant

Docetaxel (75 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).

TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy

Arm 4: Gemcitabine + Birinapant

Gemcitabine (1000 mg/m2/IV) once weekly (7 days +/- 2 days) for 3 consecutive weeks followed by 1 week off + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 2 week off for each cycle (4 weeks per cycle).

TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by two weeks off repeated every 4 weeks as tolerated in combination with chemotherapy.

Arm 5: Liposomal Doxorubicin + Birinapant

Liposomal doxorubicin (40 mg/m2/IV) every 4 weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 2 weeks off for each cycle (4 weeks per cycle).

TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by two weeks off repeated every 4 weeks as tolerated in combination with chemotherapy.

Total Total of all reporting groups

Baseline Measures
   Arm 1: Carboplatin/Paclitaxel + Birinapant   Arm 2: Irinotecan + Birinapant   Arm 3: Docetaxel + Birinapant   Arm 4: Gemcitabine + Birinapant   Arm 5: Liposomal Doxorubicin + Birinapant   Total 
Overall Participants Analyzed 
[Units: Participants]
 24   83   33   18   18   176 
Age 
[Units: Years]
Mean (Standard Deviation)
 63  (8.77)   59.6  (11.58)   60.7  (11.16)   56.7  (8.55)   56.5  (10.44)   59.7  (10.82) 
Gender 
[Units: Participants]
           
Female   13   39   15   11   13   91 
Male   11   44   18   7   5   85 
Ethnicity (NIH/OMB) 
[Units: Participants]
           
Hispanic or Latino   1   2   1   2   2   8 
Not Hispanic or Latino   23   81   32   16   16   168 
Unknown or Not Reported   0   0   0   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
           
American Indian or Alaska Native   0   0   0   0   0   0 
Asian   0   0   0   0   1   1 
Native Hawaiian or Other Pacific Islander   0   0   0   0   0   0 
Black or African American   2   12   3   3   3   23 
White   22   71   30   15   13   151 
More than one race   0   0   0   0   0   0 
Unknown or Not Reported   0   0   0   0   1   1 
Region of Enrollment 
[Units: Participants]
           
United States   24   83   33   18   18   176 


  Outcome Measures
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1.  Primary:   Number of Subjects With Adverse Events as a Measure of Safety and Tolerability   [ Time Frame: 1 Cycle (3-4 weeks) ]

2.  Secondary:   Evaluation of Anti-tumor Efficacy   [ Time Frame: Every 2 cycles ]

3.  Secondary:   Evaluation of Pharmacokinetics and Translational Biomarkers   [ Time Frame: Cycle 1 and Cycle 2 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
No text entered.


  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: Vice President, Clinical Research
Organization: TetraLogic Pharmaceuticals
phone: 610-889-9900 ext 141
e-mail: Jeffrey.Skolnik@tetralogicpharma.com



Responsible Party: TetraLogic Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01188499     History of Changes
Other Study ID Numbers: TL32711-POC-0078-PTL
Study First Received: August 23, 2010
Results First Received: April 21, 2016
Last Updated: April 21, 2016
Health Authority: United States: Food and Drug Administration