Status:
COMPLETED
Dose Escalation Safety Study of TL32711 in Adults With Refractory Solid Tumors or Lymphoma
Lead Sponsor:
TetraLogic Pharmaceuticals
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
A Phase 1 open-label, non-randomized dose escalation study to determine the maximum tolerated dose (MTD) and characterize the safety and tolerability of Birinapant (TL32711).
Detailed Description
The purpose of this Phase 1 open-label, non-randomized dose escalation study is to determine the maximum tolerated dose (MTD) and characterize the safety and tolerability of Birinapant (TL32711) when ...
Eligibility Criteria
Inclusion
- Key
- Advanced metastatic or unresectable malignancy that is refractory to currently available standard therapies or no effective therapy exists. The subject's malignancy must be confirmed by prior pathologic study.
- Evaluable disease (measurable or non-measurable) by Response Evaluation Criteria in Solid Tumors (RECIST, Version 1.1) or Revised Response Criteria for Malignant Lymphoma (RRCML) (Cheson 2007).
- Life expectancy greater than 3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
- Adequate renal function, defined as serum creatinine ≤ 1.5 X upper limit of normal (ULN), or calculated creatinine clearance ≥ 60 ml/min.
- Adequate hepatic function, defined as aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 3 X ULN and total bilirubin \< 1.5 X ULN.
- Adequate bone marrow function, defined as absolute neutrophil (ANC) ≥ 1,500/mm3 (≥1.5 X106/L), platelet count ≥ 75,000/mm3 (≥ 75 X106/L), and hemoglobin ≥ 10 mg/dL in the absence of transfusion.
- Key
Exclusion
- Recent anti-cancer treatment defined as:
- Standard or investigational anti-cancer therapy within 4 weeks prior to first dose of TL32711. Exception: continued hormonal interventions for sensitive diseases.
- Radiation therapy within 2 weeks prior to the first dose of TL32711.
- Clinically significant pulmonary illness resulting in Grade ≥ 2 hypoxia (National Cancer Institute Common Terminology criteria for Adverse Events \[NCI CTCAE, v4\]) or any requirement for supplemental oxygen, or pulse oximetry less than 90% saturation on room air.
- Symptomatic or uncontrolled brain metastases requiring current treatment (less than 4 weeks from last cranial radiation or 2 weeks from last steroids).
- Impaired cardiac function or clinically significant cardiac disease.
- Ongoing auto-immune disease or with history of an auto-immune disease within the past 5 years. Auto-immune disease include but are not limited to systemic lupus erythematosis, scleroderma, rheumatoid arthritis, psoriasis, psoriatic arthritis, ulcerative colitis and regional enteritis (Crohn's disease).
- Systemic or chronic topical corticosteroids or immunosuppressive therapy within 4 weeks prior to study entry or anticipated need of systemic corticosteroids or immunosuppressive therapy during study participation.
- Skin lesions of Grade ≥ 2 severity (NCI CTCAE v4), except alopecia.
- Lack of recovery of prior adverse events to Grade ≤1 severity (NCI CTCAE v 4) (except alopecia or neuropathy) due to medications administered prior to the first dose of TL32711.
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00993239
Start Date
November 1 2009
End Date
March 1 2013
Last Update
March 3 2016
Active Locations (3)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
2
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
3
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111