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

NCT01188707 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2020-10-19

No results posted yet for this study

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

Interventions

DRUG

Belinostat and Erlotinib

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.

Sponsors & Collaborators

  • Valerio Therapeutics

    collaborator INDUSTRY

  • Roche Pharma AG

    collaborator INDUSTRY

  • Copenhagen University Hospital at Herlev

    collaborator OTHER

  • Bispebjerg Hospital

    collaborator OTHER

  • Herlev Hospital

    lead OTHER

Principal Investigators

  • Jon L Andersen, MD · Dept of Oncology Copenhagen University Hospital Herlev

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-01
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01188707 on ClinicalTrials.gov