NCT01112527

An Open-Label, Phase 2 Trial of Orally Administered PF-00299804 in Adult Patients With Relapsed/Recurrent Glioblastoma (GBM)

Completed Phase 2 Last updated 14 August 2018

What this trial tests

Phase 2 trial testing PF-00299804 in Glioblastoma in 58 participants. Completed in 1 September 2015.

Timeline

1 April 2010

Primary endpoint
1 September 2015

1 September 2015

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	58
Start date	1 April 2010
Primary completion	1 September 2015
Estimated completion	1 September 2015
Sites	4 locations across United States

Drugs / interventions tested

• PF-00299804 — full drug profile →

Conditions studied

• Glioblastoma — all drugs for Glioblastoma →
• GBM — all drugs for GBM →
• Glioblastoma Multiforme — all drugs for Glioblastoma Multiforme →

Sponsor

Massachusetts General Hospital

Who can join

18 and older, any sex, with Glioblastoma or GBM. 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.

• Progression-Free Survival
  Time frame: 2 years
  Assess progression-free survival at six months in patients with recurrent GBM and EGFR amplification in archival tumor material who are treated with continuous daily dosing of PF-00299804 (Arm B)

Sponsor's own description

There are three arms to this study (A, B and C) The purpose of this research study during Arm A is to see how much of PF-00299804 gets into the brain tumor. For many brain tumors, one reason that chemotherapy drugs might not be effective is that the drug may not be able to get into the brain tumor and kill the cancer cells. We will determine how much PF-00299804 gets into the brain tumor by obtaining a sample of the tumor from the surgery that the participant already has scheduled. The purpose of this research study during Arm B and C, is to determine how well PF-00299804 works in killing cancer cells. PF-00299804 works by binding to specific proteins found on the surface of some cancer cells that promote a growth signal. Blocking this signal from reaching its target on the cancer cells may slow or stop the cancer from growing.

Publications & conference data

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

1. EGFR heterogeneity and implications for therapeutic intervention in glioblastoma.
   Eskilsson E, Røsland GV, Solecki G, Wang Q, et al · · 2018 · cited 228× · PMID 29040782 · DOI 10.1093/neuonc/nox191
2. Toward precision medicine in glioblastoma: the promise and the challenges.
   Prados MD, Byron SA, Tran NL, Phillips JJ, et al · · 2015 · cited 163× · PMID 25934816 · DOI 10.1093/neuonc/nov031
3. Updated Insights on EGFR Signaling Pathways in Glioma.
   Oprita A, Baloi SC, Staicu GA, Alexandru O, et al · · 2021 · cited 111× · PMID 33435537 · DOI 10.3390/ijms22020587
4. A Systematic Review of Glioblastoma-Targeted Therapies in Phases II, III, IV Clinical Trials.
   Cruz Da Silva E, Mercier MC, Etienne-Selloum N, Dontenwill M, et al · · 2021 · cited 99× · PMID 33918704 · DOI 10.3390/cancers13081795
5. Targeted molecular therapies against epidermal growth factor receptor: past experiences and challenges.
   Reardon DA, Wen PY, Mellinghoff IK. · · 2014 · cited 80× · PMID 25342602 · DOI 10.1093/neuonc/nou232
6. Treating recurrent glioblastoma: an update.
   Kamiya-Matsuoka C, Gilbert MR. · · 2015 · cited 52× · PMID 25768333 · DOI 10.2217/cns.14.55
7. Challenges to targeting epidermal growth factor receptor in glioblastoma: escape mechanisms and combinatorial treatment strategies.
   Roth P, Weller M. · · 2014 · cited 49× · PMID 25342600 · DOI 10.1093/neuonc/nou222
8. Prospective, high-throughput molecular profiling of human gliomas.
   Chi AS, Batchelor TT, Dias-Santagata D, Borger D, et al · · 2012 · cited 43× · PMID 22821383 · DOI 10.1007/s11060-012-0938-9