NCT01918761

Dacomitinib + Pemetrexed for Patients With Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC)

Dacomitinib + Pemetrexed for Patients With Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC): a Phase I Trial to Identify a Dose of Dacomitinib in Combination With Pemetrexed That is Safe and Tolerated as Determined by the Incidence of Dose Limiting Toxicities (DLTs)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Central European Cooperative Oncology Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To identify a dose of dacomitinib in combination with pemetrexed that is safe and tolerated as determined by the incidence of DLTs (dose limiting toxicities).

Detailed description

This open label phase Ib trial aims to determine the safety, tolerability, the pharmacokinetic profile, and to identify a dose of dacomitinib in combination with pemetrexed. Three sites in Austria will participate in this study. Six to nine patients will initially be enrolled to receive the target dose of 45 mg qd dacomitinib (starting from day 2 of first cycle) in combination with pemetrexed (500 mg/m² 10 min infusion, once every 3 weeks). One cycle is defined as 21 days. The first 3 subjects will be enrolled at a rate of ≤ 1 subject per week. If the target dose regimen is safe based on the incidence of DLT another 3 subjects will be enrolled. If the dose of 45 mg qd is not safe alternate lower doses will be explored (dose level -1, dose level -2) to identify the maximal tolerated dose (MTD) of dacomitinib in combination of pemetrexed. Six to nine patients per dose level will be enrolled.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Dacomitinib, Pemetrexed	Pemetrexed 500mg/m2 i.v (q21d) Dacomitinib 45mg orally (continuous)

Timeline

• Start date: 2013-07-30
• Primary completion: 2016-09-15
• Completion: 2016-09-15
• First posted: 2013-08-08
• Last updated: 2019-12-30
• Results posted: 2019-12-30

Locations

2 sites across 1 country: Austria