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A Phase I/II Clinical Trial of Oral Vorinostat (MK0683) in Combination With Erlotinib in Patients With Relapsed/Refractory Non-Small-Cell Lung Cancer


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma, Non-Small-Cell Lung

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Trial Information

A Phase I/II Clinical Trial of Oral Vorinostat (MK0683) in Combination With Erlotinib in Patients With Relapsed/Refractory Non-Small-Cell Lung Cancer


Inclusion Criteria:



- Males and females 18 years of age and older with a confirmed diagnosis of
non-small-cell lung cancer (NSCLC) who have failed at least one prior treatment for
NSCLC.

- Patients must have proven disease by CT scan or MRI.

- Patients must be at least 4 weeks from any chemotherapy for cancer or from any
surgeries or from any treatment using an investigational drug.

- Patients must be 2 weeks out from radiation therapy.

- At screening the patient must have normal lab results and can not be pregnant.

- Women and men must agree to practice adequate birth control during the study.

- Patient has the ability to understand and sign the consent form.

Exclusion Criteria:

- Patient had prior treatment with vorinostat or erlotinib.

- Patient has any of the following conditions: active infections including hepatitis B
or C, unstable brain metastases, swallowing difficulties, heart problems, significant
eye abnormalities, drug or alcohol abuse, mental illness or pregnancy.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose Limiting Toxicity (DLT) Occurring in Cycle 1 of the Phase I Portion of the Study

Outcome Time Frame:

Day 1 to 28 in the Phase I portion of the study

Safety Issue:

Yes

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Merck

Authority:

United States: Food and Drug Administration

Study ID:

2005_080

NCT ID:

NCT00251589

Start Date:

November 2005

Completion Date:

December 2007

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Relapsed Non-Small-Cell Lung Cancer
  • Refractory Non-Small-Cell Lung Cancer
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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