Dose Escalation, Combination Chemotherapy Safety Study of Birinapant (TL32711), in Subjects With Advanced or Metastatic Solid Tumors
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ClinicalTrials.gov Identifier: NCT01188499 |
Recruitment Status
:
Completed
First Posted
: August 25, 2010
Results First Posted
: May 30, 2016
Last Update Posted
: May 30, 2016
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Sponsor:
TetraLogic Pharmaceuticals
Information provided by (Responsible Party):
TetraLogic Pharmaceuticals
- Study Details
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Tracking Information | ||||||||||||||||||||||
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First Submitted Date ICMJE | August 23, 2010 | |||||||||||||||||||||
First Posted Date ICMJE | August 25, 2010 | |||||||||||||||||||||
Results First Submitted Date | April 21, 2016 | |||||||||||||||||||||
Results First Posted Date | May 30, 2016 | |||||||||||||||||||||
Last Update Posted Date | May 30, 2016 | |||||||||||||||||||||
Study Start Date ICMJE | October 2010 | |||||||||||||||||||||
Actual Primary Completion Date | October 2013 (Final data collection date for primary outcome measure) | |||||||||||||||||||||
Current Primary Outcome Measures ICMJE |
Number of Subjects With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 1 Cycle (3-4 weeks) ] Number of subjects with adverse events as a measure of safety and tolerability including changes in vital signs, electrocardiograms (ECGs), safety and laboratory parameters
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Original Primary Outcome Measures ICMJE | Same as current | |||||||||||||||||||||
Change History | Complete list of historical versions of study NCT01188499 on ClinicalTrials.gov Archive Site | |||||||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | |||||||||||||||||||||
Original Other Outcome Measures ICMJE | Not Provided | |||||||||||||||||||||
Descriptive Information | ||||||||||||||||||||||
Brief Title ICMJE | Dose Escalation, Combination Chemotherapy Safety Study of Birinapant (TL32711), in Subjects With Advanced or Metastatic Solid Tumors | |||||||||||||||||||||
Official Title ICMJE | A Phase 1B/2A, Open-label, Non-randomized, Multi-arm Study of TL32711 in Combination With Chemotherapy in Subjects With Advanced or Metastatic Solid Tumors | |||||||||||||||||||||
Brief Summary | This is a dose escalation safety study of birinapant (TL32711) in combination with chemotherapy in subjects with advanced or metastatic solid tumors. | |||||||||||||||||||||
Detailed Description | The purpose of this study is to determine the safety and maximum tolerated dose of birinapant (TL32711) as a 30 minute intravenous infusion once a week, for 2 consecutive weeks, when combined with standard regimens of chemotherapy in subjects with advanced or metastatic solid tumors. Additionally the study will assess anti-tumor activity, pharmacokinetics, and exploratory biomarkers as a measurement of pharmacodynamic effects. | |||||||||||||||||||||
Study Type ICMJE | Interventional | |||||||||||||||||||||
Study Phase | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Cancer | |||||||||||||||||||||
Intervention ICMJE | Drug: Birinapant
Other Name: TL32711 |
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Study Arms |
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Publications * | Not Provided | |||||||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||||||||||||||||||||
Recruitment Status ICMJE | Completed | |||||||||||||||||||||
Actual Enrollment ICMJE |
176 | |||||||||||||||||||||
Original Estimated Enrollment ICMJE |
120 | |||||||||||||||||||||
Actual Study Completion Date | March 2014 | |||||||||||||||||||||
Actual Primary Completion Date | October 2013 (Final data collection date for primary outcome measure) | |||||||||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||||||||||||||||||||
Accepts Healthy Volunteers | No | |||||||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||||||||||||||
Listed Location Countries ICMJE | United States | |||||||||||||||||||||
Removed Location Countries | ||||||||||||||||||||||
Administrative Information | ||||||||||||||||||||||
NCT Number ICMJE | NCT01188499 | |||||||||||||||||||||
Other Study ID Numbers ICMJE | TL32711-POC-0078-PTL | |||||||||||||||||||||
Has Data Monitoring Committee | No | |||||||||||||||||||||
U.S. FDA-regulated Product | Not Provided | |||||||||||||||||||||
IPD Sharing Statement | Not Provided | |||||||||||||||||||||
Responsible Party | TetraLogic Pharmaceuticals | |||||||||||||||||||||
Study Sponsor ICMJE | TetraLogic Pharmaceuticals | |||||||||||||||||||||
Collaborators ICMJE | Not Provided | |||||||||||||||||||||
Investigators ICMJE |
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PRS Account | TetraLogic Pharmaceuticals | |||||||||||||||||||||
Verification Date | April 2016 | |||||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |