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Phase I/II of Oral Vorinostat Combination With Erlotinib in NSCLC Patients With EGFR Mutations With DP After Erlotinib.

NCT00503971 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2025-03-07

Study results available
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Summary

This is an open label, non-randomized, sequential, phase I/II trial in patients with stage IIIB or IV non-small cell lung cancer (NSCLC) with EGFR mutations after progression to Erlotinib. The study will have two parts. The first part (phase I) will be a dose finding (MTD) study to be implemented at three hospitals. The second part of the study (phase II) will asses the safety and efficacy of the combination. In this second part (phase II) patients will be treated with oral Erlotinib 150 mg P.O daily plus oral Vorinostat administered according to the results of the phase I. The study endpoints to be evaluated will include safety and response rate (RR) as primary endpoints and clinical benefit rate (CBR), time to progression, time to response, response duration and progression free survival as secondary endpoints. All the patients (phase I and II) will be treated until progression disease, unacceptable toxicity or withdrawal of the consent, and will be treated at the discretion of the principal investigator.

Conditions

Interventions

DRUG

Vorinostat plus Erlotinib

Phase I: Dose level 1: 300 mg V d1-7 every 21 days plus 100 mg E daily Dose level 2: 400 mg V d1-7 every 21 days plus 100 mg E daily Dose level 2b: 300 mg V d1-7 and 15-21 every 28 days plus 100 mg E daily Dose level 3: 400 mg V d1-7 and 15-21 every 28 days plus 150 mg E daily Phase II: Dose level 3: 400 mg V d1-7 and 15-21 every 28 days plus 150 mg E daily

Sponsors & Collaborators

Principal Investigators

  • Teresa Moran, MD · Medical Oncology Service. Institut Catala d'Oncologia- ICO. Hospital Germans Trias i Pujol. Badalona - Barcelona (Spain)

  • Dolores Isla, MD · Medical Oncology Service. Hospital Clinico Lozano Blesa. Zaragoza. Spain

  • Felip Cardenal, MD · Institut Catala d'Oncologia. Centre Sanitari i Universitari de Bellvitge (CSUB). Hospitalet de Llobregat (Barcelona). Spain

  • Bertomeu Massutti, MD · Medical Oncology Service. General Hospital. Alicante. Spain

  • Rafael Rosell, MD · Medical Oncology Service. Institut Catala d'Oncologia- ICO. Hospital Germans Trias i Pujol. Badalona - Barcelona (Spain)

  • Noemi Reguart, MD · Medical Oncology Service. Hospital Clinic - Barcelona (Spain)

  • Amelia Insa, MD · Medical Oncology Service. Hospital Clínico Universitario - Valencia (Spain)

  • Cinta Pallarés, MD · Medical Oncology Service. Hospital de la Santa Creu i Sant Pau - Barcelona (Spain)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • Spain

Study Locations

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Entities

Diseases
Companies

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 NCT00503971 on ClinicalTrials.gov