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Spots Global Cancer Trial Database for Dose Escalation Safety Study of TL32711 in Adults With Refractory Solid Tumors or Lymphoma

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Trial Identification

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

Conditions

Cancer

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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