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Brief Title: Dose Escalation Safety Study of TL32711 in Adults With Refractory Solid Tumors or Lymphoma
Official Title: A Phase 1, Open-Label, Non-randomized, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TL32711 in Adults With Refractory Solid Tumors or Lymphoma
Study ID: NCT00993239
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 administered as a 30 minute intravenous infusion once weekly for three weeks per repeated 4 week intervals in subjects with refractory solid tumors or lymphoma. Additionally study will assess anti-tumor activity, pharmacokinetics, and exploratory biomarkers as a measurement of pharmacodynamic effects.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Roswell Park Cancer Institute, Buffalo, New York, United States
University of Pennsylvania Abramson Cancer Center, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Name: Ravi Amaravadi, MD
Affiliation: University of Pennsylvania, Abramson Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: Lainie P Martin, MD
Affiliation: Fox Chase Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: Alex Adjei, MD, PhD
Affiliation: Roswell Park Cancer Institute
Role: PRINCIPAL_INVESTIGATOR