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Phase I/II Study of Vorinostat and Gefitinib in Relapsed/ or Refractory Patients With Advanced Non-small Cell Carcinoma (NSCLC)

Phase 1/Phase 2
18 Years
Open (Enrolling)
Non-Small-Cell Lung Carcinoma

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Trial Information

Phase I/II Study of Vorinostat and Gefitinib in Relapsed/ or Refractory Patients With Advanced Non-small Cell Carcinoma (NSCLC)

Phase I design

- Three patients will be treated per cohort for one cycle (28 days per cycle).

- If no DLTs are recorded, treatment will continue and three patients will be treated in
the subsequent cohort.

- However, if a patient develops a DLT, another three patients will be treated in this
cohort for one cycle.

- If there are no more DLTs, dose escalation continues.

- If more than one of three patients develop a DLT in any cohort, another three patients
will be treated in the next lower dosage cohort.

- If no DLTs are recorded in any of the cohorts, cohort 3 will be expanded to six

- Up to 12 patients will be enrolled at the MTD.

- The phase II dose for this combined treatment will be therefore defined as the highest
dosage cohort in which six patients had been treated and there are less than three

Inclusion Criteria:

- Histologic or cytologic diagnosis of NSCLC, Stage IV or selected stage IIIB (with
positive pleural effusion or multiple ipsilateral lung nodules) according to the
American Joint Committee on Cancer (AJCC).

- Previously treated with at least one platinum-based chemotherapy.

- Before study entry, a minimum of 28 days must have elapsed since any prior

- Prior radiation therapy is allowed as long as the irradiated area is not the only
source of measurable disease.

- No other forms of cancer therapy, such as radiation, immunotherapy for at least 2
weeks before the enrollment in study.

- Performance status of 0-2 on the ECOG criteria.

- At least one unidimensionally measurable lesion meeting Response Evaluation Criteria
in Solid Tumors (Revised RECIST guideline version 1.1)

- Estimated life expectancy of at least 8 weeks.

- Patient compliance that allow adequate follow-up.

- Adequate hematologic (WBC count 4,000/mm3, platelet count 150,000/mm3), hepatic
(bilirubin level 1.5 mg/dL, AST/ALT 80 IU/L), and renal (creatinine concentration
1.5 mg/dL) function.

- Informed consent from patient or patient's relative.

- Males or females at least 18 years of age.

- If female: childbearing potential either terminated by surgery, radiation, or
menopause, or attenuated by use of an approved contraceptive method (intrauterine
device [IUD], birth control pills, or barrier device) during and for 3 months after
trial. If male, use of an approved contraceptive method during the study and 3
months afterwards. Females with childbearing potential must have a urine negative hCG
test within 7 days prior to the study enrollment.

- Patients with brain metastasis are allowed unless there were clinically significant
neurological symptoms or signs

Exclusion Criteria:

- Presence of small-cell lung cancer alone or with NSCLC

- Unresolved chronic toxic effects from previous anticancer therapy: but patient could
be enrolled, if they have recovered from any treatment-related toxicities NCI CTCAE
grade ≤2

- Inability to swallow tablets

- Second primary malignancy (except in situ carcinoma of the cervix or adequately
treated basal cell carcinoma of the skin or prior malignancy treated more than 5
years ago without recurrence).

- More than three previous chemotherapy regimens for NSCLC

- Previous treatment with any EGFR-TKI

- Patients who have been exposed to any prior HDAC inhibitor, with the exception of
exception of valpronic acid used for treating seizures, provided there is a 30-day
washout period

- Patients with active HIV or hepatitis B or C infection

- Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, cyclosporine
A, valpronic acid, Phenobarbital, ketoconazole, coumarin-derivative anticoagulants or
St John's wort; severe or uncontrolled systemic disease; clinically active
interstitial lung disease (except uncomplicated lymphangitic carcinomatosis)
pregnancy; and breastfeeding.

- MI within preceding 6 months or symptomatic heart disease, including unstable angina,
congestive heart failure or uncontrolled arrhythmia

- Serious concomitant infection including postobstructive pneumonia

- Major surgery other than biopsy within the past two weeks.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-Free Survival

Outcome Description:

The first day of treatment to the date that disease progression is reported or death date

Outcome Time Frame:

every 8 weeks

Safety Issue:


Principal Investigator


Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Center


Korea: Food and Drug Administration

Study ID:




Start Date:

June 2010

Completion Date:

December 2012

Related Keywords:

  • Non-Small-Cell Lung Carcinoma
  • Gefitinib
  • Vorinostat
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms