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Romidepsin and Erlotinib Hydrochloride in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

NCT01302808 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2021-01-20

Study results available
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Summary

RATIONALE: Romidepsin and erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase I/II trial is studying the side effects and best dose of romidepsin when given together with erlotinib hydrochloride and to see how well they work in treating patients with stage III or stage IV non-small cell lung cancer.

Conditions

Interventions

COMBINATION_PRODUCT

Erlotinib plus Romidepsin (8 mg/m^2)

COMBINATION_PRODUCT

Erlotinib plus Romidepsin (10 mg/m^2)

COMBINATION_PRODUCT

Erlotinib plus Romidepsin (10 mg/m^2) + Antiemetic prophylaxis

COMBINATION_PRODUCT

(Erlotinib plus Romidepsin (8mg/m^2)) + Antiemetic prophylaxis

Sponsors & Collaborators

  • Celgene

    collaborator INDUSTRY

  • Genentech, Inc.

    collaborator INDUSTRY

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • David E. Gerber, MD · Simmons Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT01302808 on ClinicalTrials.gov