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

NCT01918761 | Terminated Phase 1 Results

• 1 other identifier: CECOG/ NSCLC.1.1.001
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Non Small Cell Lung Cancer

Keywords

NSCLC; Stage IV; Pemetrexed; Dacomitinib

Outcome Measures

Primary Outcomes (1)

• Dose Limiting Toxicities (DLTs)

  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).

  From start of treatment to end of treatment or death, whichever occurs first. The study was suspended after 36 months.

Secondary Outcomes (3)

• Overall Response Rate

  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 Survival

  until date of death. The study was suspended after 36 months.

• Progression-free Survival

  Up to progression or death due to any cause. The study was suspended after 36 months

Study Arms (1)

Dacomitinib, Pemetrexed

EXPERIMENTAL

Pemetrexed 500mg/m2 (i.v) q21d Dacomitinib 45mg/ orally (continuous)

Drug: Dacomitinib, Pemetrexed

Interventions

Dacomitinib, Pemetrexed DRUG

Pemetrexed 500mg/m2 i.v (q21d) Dacomitinib 45mg orally (continuous)

Also known as: Alimta

Dacomitinib, Pemetrexed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• Histologically or cytologically confirmed stage IV non-squamous NSCLC
• Patients who are candidates to receive pemetrexed monotherapy
• If pemetrexed has been administered as first line therapy there must be a treatment free interval of at least one cycle (21 days)
• Measurable disease by RECIST criteria version 1.1.
• ≥18 years of age
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
• Adequate left ventricular ejection fraction (LVEF) ≥ 50% by either echocardiogram or multigated acquisition scan (MUGA)
• Adequate organ function, including:
• Adequate bone marrow reserve: absolute neutrophil count (ANC) should be ≥ 1500 cells/mm3, platelets should be ≥ 100.000 cells/mm3
• Creatinine clearance ≥ 45 mL/min
• Total bilirubin ≤ 1.5 x upper normal limit (ULN)
• Aspartate Aminotransferase (AST) (SGOT) ≤ 3 x ULN (≤ 5.0 x ULN if hepatic metastases)
• Alanine Aminotransferase (ALT) (SGPT) ≤ 3 x ULN (≤ 5.0 x ULN if hepatic metastases)
• Female patients or their partners must be postmenopausal (defined as 12 months of amenorrhea following last menses), surgically sterile or must agree to use effective contraception while receiving trial treatment and for at least 3 months thereafter (the definition of effective contraception will be based on the judgment of the investigator). Male patients or their partners must be surgically sterile or must agree to use a barrier method of contraception while receiving trial treatment and for at least 3 months thereafter. (In all cases the definition of effective contraception will be based on the judgment of the investigator).

You may not qualify if:

• Any evidence of mixed histology that includes elements of small cell or carcinoid lung cancer
• Predominantly squamous cell histology
• Patients with symptomatic brain metastases
• Chemotherapy, radiotherapy, biological or investigational agents within two weeks of baseline disease assessments
• Patients with uncontrolled or significant cardiovascular disease, including:
• Myocardial infarction within 12 months
• Uncontrolled angina within 6 months
• Congestive heart failure within 6 months
• Diagnosed or suspected congenital long QT syndrome
• Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes)
• Prolonged QTc interval on pre-entry electrocardiogram. QTc must be less than CTC Grade 2 (≤480 msec) using appropriate correction formula with manual read by investigator if required. The echocardiogram (ECG) may be repeated for evaluation of eligibility after management of correctable causes for observed QTc prolongation
• Any history of second or third degree heart block (may be eligible if currently have a pacemaker)
• Heart rate \<50/minute on baseline electrocardiogram
• Uncontrolled hypertension
• Prior malignancy: Patients will not be eligible if they have evidence of other malignancy (other than non-melanoma skin cancer or in situ cervical cancer, or localized and presumed cured prostate cancer with prostate specific antigen (PSA) \< ULN) within the last 3 years.

Sponsors & Collaborators

• Central European Cooperative Oncology Group: lead

Study Sites (2)

Medizinische Universität Graz Klinische Abteilung für Onkologie

Graz, Austria

Location

Universitätsklinik für Innere Medizin I

Innsbruck, Austria

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

dacomitinib; Pemetrexed

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Results Point of Contact

• Title: MD Christiane Thallinger
• Organization: Cecog

office@cecog.at

+43 1 409 77 25

Study Officials

• Christoph C Zielinski, Univ. Prof.

  Univ Clinic for Internal Medicine I, Dep of Oncology, Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2013
• First Posted: August 8, 2013
• Study Start: July 30, 2013
• Primary Completion: September 15, 2016
• Study Completion: September 15, 2016
• Last Updated: December 30, 2019
• Results First Posted: December 30, 2019

Record last verified: 2018-01

Locations

AU (2)