Phase I Trial of PX-478

Phase I Trial of PX-478

Solid Tumors

Completed

1

Start Date 08/01/2007

Age of Trial (yrs) 16.7

Gleevec-resistant

HIF-1α inhibitor

Block related tumor signal paths Block tumor blood vessel growth

GIST not specified. GIST patient enrollment unknown.

PX-478-001

ProlX Pharmaceuticals, Oncothyreon, Inc.

See site contact info below

Oral

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment
Official Title: A Phase 1 Trial of Oral PX-478 (a HIF-1α Inhibitor) in Patients With Advanced Solid Tumors or Lymphoma
Further study details as provided by ProlX Pharmaceuticals:
Primary Outcome Measures:
* Determination of MTD and PK profile when given orally on days 1 to 5 of a 21 day cycle; and, evaluation of the safety profile and PD effects of the drug on the HIF-1α pathway and related tumor markers. [Time Frame: 21 days]
Secondary Outcome Measures:
* Evaluation of the effects of PX-478 on tumor blood flow and vascular permeability as measured by DCE MRI; and, evaluation of the anti-tumor activity of PX-478 in patients with advanced malignancies [Time Frame: 6 weeks]
Must be 18 years old or older.
Patients with Familial Paraganglioma/Gastric Stromal Sarcoma might be good candidates for this trial.
Total Enrollment: 36
Study start: August 2007