A Trial of Belinostat in Combination With Erlotinib in Patients With Non-small Cell Lung Cancer

NCT01188707 | Terminated Phase 1 DMC

• 1 other identifier: LU0928
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The Belinostat-Erlotinib trial is designed as an open, non randomized phase I / II trial to assess the efficacy and safety of Belinostat in combination with Erlotinib in patients with non-small cell lung cancer who are eligible for treatment with erlotinib.

Conditions

Non Small Cell Lung Cancer

Keywords

Non small cell lung cancer; Belinostat; Erlotinib; HDAC inhibitor; Phase I/II

Outcome Measures

Primary Outcomes (1)

• Safety

  The primary purpose of the phase I part of the trial is to establish the tolerance dose (maximum tolerated dose (MTD) and dose limiting toxicity (DLT).

  1 year

Secondary Outcomes (1)

• Efficacy

  1 year

Study Arms (1)

Belinostat, Erlotinib, NSCLC

EXPERIMENTAL

Drug: Belinostat and Erlotinib

Interventions

Belinostat and Erlotinib DRUG

The design of the first phase is a 3 +3 phase I trial. The Belinostat dose will start at 500 mg and will be increased with 250 mg until a maximum dose of 1500 mg, administered daily in 2/3 weeks. Each patient will at the same time receive 150 mg of Erlotinib daily continously. When the patient is enrolled at one dose level, there will be no further dose escalation for that individual patient. 3 patients will be treated at each dose level.

Also known as: Tarceva

Belinostat, Erlotinib, NSCLC

Eligibility Criteria

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

You may qualify if:

• Signed consent of an approved informed consent form
• A. For the dose escalation phase: Patients with histological or cytological confirmed non-small cell lung cancer who are rated suitable for treatment with Erlotinib B. For MTD expansion phase: Patients diagnosed with non- small cell lung cancer rated suitable for treatment with Erlotinib and with measurable disease according to RECIST version 1.1
• Performance status (ECOG) ≤ 2
• Life expectancy at least 3 months
• Age ≥ 18 years
• Acceptable liver, kidney and bone marrow function, defined as:
• Bilirubin ≤ 1.5 x upper limit of normal (ULN)
• ASAT, ALAT and alkaline phosphatase ≤ 3 x ULN (if liver metastases is ≤ 5 x ULN allowed)
• Serum creatinine ≤ 1.5 x upper limit of normal (ULN)
• WBC\> 2.5 x 109 / l, neutrophils\> 1.0 x 109 / l, platelets\> 100 x 109 / l
• Hemoglobin\> 9.0 g / dl or\> 5.6 mmol / l
• Acceptable coagulation: PT and APTT within ≤ 1.5 x ULN or in the therapeutic range if given anticoagulant
• A negative pregnancy test for women of childbearing age. In fertile men and women the use of effective contraception methods are required during the trial
• Serum potassium within normal range

You may not qualify if:

• Treatment with experimental drugs within the last 4 weeks
• Former anti-cancer therapy within the last 3 weeks before the start of experimental treatment, including chemotherapy, radiotherapy, endocrine therapy or immunotherapy
• Simultaneous presence of active infection or other concomitant present medical condition likely to affect the experimental procedures, including significant cardiovascular disease (New York Heart Association Class III or IV heart disease, myocardial infarction within the past 6 months, unstable angina, congestive heart failure requiring treatment, unstable arrhythmia or the need for antiarrhythmic drugs or signs of ischemia on ECG, marked baseline prolongation of QT / QTc interval, for example repeated demonstration of a QTc interval\> 500 msec; long QT syndrome; required the use of concurrent medication on dosage belinostat days, which may cause torsades de pointes (see Appendix 1).
• Altered mental status that prevents understanding of the informed consent process and / or execution of the necessary experiments
• Secondary malignancy present (previous malignancy accepted if cured by treatment for \> 3 years ago)
• Intestinal obstruction or threatening bowel obstruction

Sponsors & Collaborators

• Herlev Hospital: lead
• Copenhagen University Hospital at Herlev: collaborator
• Bispebjerg Hospital: collaborator
• Valerio Therapeutics: collaborator
• Roche Pharma AG: collaborator

Study Sites (1)

Dept of Oncology Copenhagen University Hospital Herlev

Copenhagen, 2730, Denmark

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

belinostat; Erlotinib Hydrochloride

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)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jon L Andersen, MD

  Dept of Oncology Copenhagen University Hospital Herlev

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 24, 2010
• First Posted: August 25, 2010
• Study Start: October 1, 2010
• Primary Completion: June 30, 2011
• Study Completion: June 30, 2011
• Last Updated: October 19, 2020

Record last verified: 2020-10

Locations

DK (1)