NCT00609999

Ph I Dasatinib + Erlotinib in Recurrent MG

Phase I Study of Dasatinib Plus Erlotinib in Recurrent Malignant Glioma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary: To determine maximum tolerated dose \& dose limiting toxicity of dasatinib when combined w erlotinib among pts w recurrent MG Secondary: To further evaluate safety \& tolerability of dasatinib + erlotinib To evaluate pharmacokinetics of dasatinib when administered w erlotinib among recurrent MG pts who are on \& not on CYP-3A enzyme inducing anti-epileptic drugs To evaluate for anti-tumor activity with this regimen in this patient population

Detailed description

Tarceva administered on continuous oral dosing schedule at 150 mg/day for pts not on EIAEDs \& 450 mg/day for pts on EIAEDs. Starting dose level of dasatinib will be 100 mg once day via continuous oral daily dosing. Dasatinib will be increased in successive cohorts of enrolled pts. Pts will remain on treatment until excessive toxicity, progressive disease, withdrawal of consent/death. Pts have confirmed diagnosis of recurrent/progressive WHO gr IV MG / WHO grade III MG. Phase I 3+3 dose escalation design w 2 independently escalated stratum: stratum A-pts not on CYP3A-enzyme inducing anti-epileptic drugs; stratum B-pts on EIAEDs. Assessment of safety will be based mainly on frequency of adverse events, particularly adverse events leading to discontinuation of treatment \& on number of significant lab abnormalities.

Conditions

• Glioblastoma
• Gliosarcoma

Interventions

Type	Name	Description
DRUG	Erlotinib and Dasatinib	You will begin study drug regimen on day 1 of cycle 1 w Dasatinib. If you are undergoing Dasatinib pharmacokinetic blood analysis, Dasatinib will be taken alone until initial PK assessments are collected. Erlotinib will be begin after initial Dasatinib PK assessments are collected \& will continue to be administered w Dasatinib on continuous daily dosing schedule. Initial Dasatinib PK assessments will be collected over 24hrs between days 3-7 of cycle 1 \& at end of cycle 1. If you are not undergoing Dasatinib PK collections you will begin both Dasatinib \& Erlotinib together on day 1 of cycle 1. Both drugs will be given in continuous daily oral manner. Cycle is defined as Dasatinib \& Erlotinib given daily for 28 days for purpose of scheduling evaluations.

Timeline

• Start date: 2008-01-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2008-02-07
• Last updated: 2014-07-16

Locations

1 site across 1 country: United States