NCT00348790

A Phase II Trial of PTK-787 in Recurrent or Progressive Meningiomas

Completed Phase 2 Results posted Last updated 24 October 2018

What this trial tests

Phase 2 trial testing vatalanib in Brain and Central Nervous System Tumors in 25 participants. Completed in 1 July 2013.

Timeline

1 May 2006

Primary endpoint
1 November 2010

1 July 2013

Quick facts

Lead sponsor	Northwestern University
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	25
Start date	1 May 2006
Primary completion	1 November 2010
Estimated completion	1 July 2013
Sites	3 locations across United States

Drugs / interventions tested

• vatalanib — full drug profile →

Conditions studied

• Brain and Central Nervous System Tumors — all drugs for Brain and Central Nervous System Tumors →
• Sarcoma — all drugs for Sarcoma →

Sponsor

Northwestern University

Who can join

18 and older, any sex, with Brain and Central Nervous System Tumors or Sarcoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of Patients Who DID NOT Experience Disease Progression or Death by 6 Months After Starting Treatment.
  Time frame: From the date the first patient began treatment until the date the last patient has disease progression, becomes deceased, or completes 6 months of treatment
  Patients were assessed with imaging techniques (MRI) during screening/baseline and then every 2 months after starting treatment. Survival status and disease status were recorded. The number of patients who did not experience an event (defined as either death for any reason or progression of their disease) by 6 months after starting treatment were counted.

Sponsor's own description

RATIONALE: Vatalanib may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well vatalanib works in treating patients with recurrent or progressive meningioma.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Historical benchmarks for medical therapy trials in surgery- and radiation-refractory meningioma: a RANO review.
   Kaley T, Barani I, Chamberlain M, McDermott M, et al · · 2014 · cited 198× · PMID 24500419 · DOI 10.1093/neuonc/not330
2. Targeting protein kinases in central nervous system disorders.
   Chico LK, Van Eldik LJ, Watterson DM. · · 2009 · cited 197× · PMID 19876042 · DOI 10.1038/nrd2999
3. Profiling and targeting cancer stem cell signaling pathways for cancer therapeutics.
   Borlongan MC, Wang H. · · 2023 · cited 30× · PMID 37305676 · DOI 10.3389/fcell.2023.1125174
4. Potential Molecular Mechanisms of Recurrent and Progressive Meningiomas: A Review of the Latest Literature.
   Peng W, Wu P, Yuan M, Yuan B, et al · · 2022 · cited 4× · PMID 35712491 · DOI 10.3389/fonc.2022.850463