Dacomitinib + Pemetrexed for Patients With Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC)
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|ClinicalTrials.gov Identifier: NCT01918761|
Recruitment Status : Terminated (poor accrual)
First Posted : August 8, 2013
Results First Posted : December 30, 2019
Last Update Posted : December 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Non Small Cell Lung Cancer||Drug: Dacomitinib, Pemetrexed||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Study Start Date :||July 30, 2013|
|Actual Primary Completion Date :||September 15, 2016|
|Actual Study Completion Date :||September 15, 2016|
Experimental: Dacomitinib, Pemetrexed
Pemetrexed 500mg/m2 (i.v) q21d Dacomitinib 45mg/ orally (continuous)
Drug: Dacomitinib, Pemetrexed
Pemetrexed 500mg/m2 i.v (q21d) Dacomitinib 45mg orally (continuous)
Other Name: Alimta
- Dose Limiting Toxicities (DLTs) [ Time Frame: From start of treatment to end of treatment or death, whichever occurs first. The study was suspended after 36 months. ]The primary objective of this study is to determine the maximal tolerated dose (MTD) of the combination pemetrexed + dacomitinib by the incidence of dose limiting toxicities (DLTs).
- Overall Response Rate [ Time Frame: Until progression of disease (PD) or 24 month after end of treatment for participants with no PD. The study was suspended after 36 months ]Overall Response Rate (ORR) is defined as the proportion of patients with complete Response (CR) or partial Response (PR).
- Overall Survival [ Time Frame: until date of death. The study was suspended after 36 months. ]Overall survival (OS) defined as time from start of Dacomitinib to date of death from any cause. Patients without recorded death were censored at the date the patient was last known to be alive. Patients were followed up for survival for 24 month after end of Treatment.
- Progression-free Survival [ Time Frame: Up to progression or death due to any cause. The study was suspended after 36 months ]Progression-free survival (PFS) defined as time from start of Dacomitinib to date of progression or date of death from any cause, whichever occurred first. Patients without recorded progression or death were censored at the last date they were known to have not progressed. Patients were followed up for progression-free survival for 24 month after end of Treatment.
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): NCT01918761
|Medizinische Universität Graz Klinische Abteilung für Onkologie|
|Universitätsklinik für Innere Medizin I|
|Principal Investigator:||Christoph C Zielinski, Univ. Prof.||Univ Clinic for Internal Medicine I, Dep of Oncology, Medical University of Vienna|