PR-104 and Docetaxel or Gemcitabine in Treating Patients With Solid Tumors

Phase 1 Completed 42 enrolled Proacta, Incorporated

Non-randomizedSingle-groupOpen-labelTreatment

Summary

RATIONALE: Drugs used in chemotherapy, such as PR-104, docetaxel, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of PR-104 when given together with docetaxel or gemcitabine in treating patients with solid tumors.

Timeline

Start: 2007-02
Primary completion: 2009-10
Completion: —

Publications

McKeage MJ, Jameson MB, Ramanathan RK, Rajendran J, Gu Y, Wilson WR, Melink TJ, Tchekmedyian NS. PR-104 a bioreductive pre-prodrug combined with gemcitabine or docetaxel in a phase Ib study of patients with advanced solid tumours. BMC Cancer. 2012 Oct 25;12:496. doi: 10.1186/1471-2407-12-496.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Docetaxel	Small molecule	60 mg/m2	Intravenous
Subject	Docetaxel	Small molecule	75 mg/m2	Intravenous
Subject	Gemcitabine	Small molecule	800 mg/m2	Intravenous
Subject	PR104	Small molecule	140 mg/m2	Intravenous
Subject	PR104	Small molecule	200 mg/m2	Intravenous
Subject	PR104	Small molecule	770 mg/m2	Intravenous
Subject	PR104	Small molecule	1100 mg/m2	Intravenous

PR-104 and Docetaxel or Gemcitabine in Treating Patients With Solid Tumors

Summary

Timeline

Publications

Drugs

Indications