drugset / Trial / NCT00848601

Safety of SGI-1776, A PIM Kinase Inhibitor in Refractory Prostate Cancer and Relapsed/Refractory Non Hodgkin's Lymphoma

NCT00848601 ↗

Phase 1 Terminated 14 enrolled Astex Pharmaceuticals, Inc.
Non-randomizedSingle-groupOpen-labelOther

Summary

Patients with hormone and docetaxel refractory prostate cancer or relapsed/refractory non-Hodgkin's lymphoma for which no available standard therapy or therapy which may provide clinical benefit is available will be enrolled. Primary objectives: estimate the maximum tolerated dose and dose-limiting toxicities. Secondary objectives: Response rate, pharmacokinetic and pharmacodynamic profiles, Prostate Specific Antigen response and renal elimination.

Timeline

Start
2009-02
Primary completion
2010-10
Completion
2010-10

Outcome

Outcome not reported

Stopped: “The dose limiting toxicity of cardiac QTc prolongation was identifiedin the phase 1 study in patients with refractory prostate and lymphoma”

Drugs

EvaluationDrugModalityDoseRoute
Subject SGI-1776 Small molecule 50 mg —