Safety and Efficacy of PF-299804 (Dacomitinib), a Pan-HER Irreversible Inhibitor, in Patients With Recurrent Glioblastoma With EGFR Amplification or Presence of EGFRvIII Mutation. A Phase II CT.
|ClinicalTrials.gov Identifier: NCT01520870|
Recruitment Status : Completed
First Posted : January 30, 2012
Last Update Posted : March 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Brain Tumor, Recurrent||Drug: PF-299804 (Dacomitinib)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Pilot, Prospective, Open Label, Multicenter CT, to Evaluate the Safety and Efficacy of PF299804, a Pan-HER Irreversible Inhibitor, in Patients With Recurrent Glioblastoma With EGFR Amplification or Presence of EGFRvIII Mutation|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||March 9, 2017|
Experimental: PF-299804 (Dacomitinib)
Dacomitinib will be administered orally at a dose of 45 mg/day, until disease progression, unacceptable adverse side effects or study end. Patients at first recurrence will be enrolled onto 1 of 2 cohorts that will be recruited and analysed independently. Cohort A will include patients who have EGFRvIII mutations. Cohort B will include patients who have EGFR gene amplification but no EGFRvIII mutations.
Drug: PF-299804 (Dacomitinib)
Dacomitinib will be administered orally at a dose of 45 mg/day, until disease progression, unacceptable adverse side effects or study end.
- Progression-free survival (PFS) at six months (PFS6m) [ Time Frame: Baseline and after 6 months ]Percentage of patients who have progressed / no progress after 6 months of treatment in each of the two cohorts.
- Safety and tolerability of oral administration of PF-00299804. [ Time Frame: Up to 42 months ]Type, incidence, severity, frequency, severity and relationship with IMP of reported adverse events, physical examinations and laboratory tests. Toxicity will be classified and tabulated by NCI-CTCAE v 4.0.
- Anti-tumor response [ Time Frame: Baseline and every 12 weeks ]According to RANO criteria. Based on neurological symptoms, doses of dexamethasone and radiological response, assessed by the PI of each center. There will be central review of MRI.
- Overall survival (OS) [ Time Frame: Up to 42 months ]Time from randomization to death by any cause.
- Response duration [ Time Frame: Baseline and every 12 weeks ]Time from first objective response up to disease progression according RANO (in patients with objective responses).
- Changes in the use of glucocorticoids [ Time Frame: Baseline and every 12 weeks ]Percentage of patients decreasing doses of corticosteroids during treatment.
- Changes in neurological status. [ Time Frame: Baseline and every 12 weeks ]By means of minimental test, it will be determined the changes in neurological status of patients.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01520870
|Hospital Universitari Germans Trias I Pujol de Badalona|
|Badalona, Barcelona, Spain, 08916|
|Institut Català D'Oncologia L'Hospitalet (Ico)|
|L'Hospitalet de Llobregat, Barcelona, Spain, 08908|
|Hospital Universitario A Coruña|
|A Coruna, Coruña (A), Spain, 15006|
|Hospital Del Mar|
|Barcelona, Spain, 08003|
|Hospital de La Santa Creu I Sant Pau|
|Barcelona, Spain, 08025|
|Complejo Hospitalario Regional Virgen de Las Nieves|
|Granada, Spain, 18004|
|Hospital Ramón Y Cajal|
|Madrid, Spain, 28034|
|Hospital Clínico San Carlos|
|Madrid, Spain, 28040|
|Hospital Universitario 12 de Octubre|
|Madrid, Spain, 28041|
|Hospital Regional Universitario de Malaga|
|Complejo Hospitalario Universitario Insular-Materno Infantil|
|Palmas de Gran Canaria, Spain, 35016|
|Hospital Universitario Y Politécnico La Fe|
|Valencia, Spain, 46009|
|Principal Investigator:||Juan Sepúlveda, MD||Hospital 12 de Octubre|