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

Sponsor
Herlev Hospital
Study ID
NCT01188707
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Aug 25, 2010
Start date
Oct 1, 2010
Status verified
Oct 2020
Primary completion
Jun 30, 2011
Completion
Jun 30, 2011

Study Design

Enrollment
5 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Belinostat, Erlotinib, NSCLC

Primary Outcome Measure

Safety [ Time Frame: 1 year ]

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