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Non-Small-Cell Lung CarcinomaPhase 1/2NCT01027676

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

A Phase 1/2 study testing Study treatment in people with Non-Small-Cell Lung Carcinoma, run by National Cancer Center, Korea at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Gefitinib is an orally active epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) and produces 8-20% of response rates in patients with advanced non-small cell lung cancer (NSCLC). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small-Cell Lung Carcinoma
What is being tested?
Study treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteSouth Korea
Study dates
Jun 2010to Mar 2014
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 chemotherapy.
  • 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.
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  • 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

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 410-769

Other trials in South Korea

About this study

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

Gefitinib is an orally active epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) and produces 8-20% of response rates in patients with advanced non-small cell lung cancer (NSCLC). Vorinostat (suberoylanilide hydroxamic acid [SAHA]) is a small-molecule inhibitor of histone deacetylase (HDAC) and induces cell differentiation, cell cycle arrest, and apoptosis in several tumor cells. There is a strong synergistic antiproliferative effect of vorinostat in combination with gefitinib in NSCLC cells. Vorinostat increases expression of E-cadherin and ErbB-3, which results in increased sensitivity to gefitinib. Moreover, In-vitro studies have shown that vorinostat leads to acetylation and disruption of Hsp90, which may lead to decreases in activity of pro-growth and prosurvival client proteins (J Bio Chem 2005;280:26729, Br J Cancer 2006;95:S2). These findings suggest that combination of vorinostat with gefitinib may improve the efficacy of gefitinib in NSCLC.

Read the detailed description

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 patients.
  • 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 DLTs.
Being tested
Study treatment
Keywords
Gefitinib, Vorinostat
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Study treatmentDrug

    Gefitinib 250mg/QD plus vorinostat D1~7 \& D15-21 / QD q 4weeks

Study groups in NCT01027676
Study groupRoleWhat they receive
study armExperimentalsingle arm Gefitinib plus vorinostat
Receives: Drug: Study treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival

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

    Measured: every 8 weeks

Secondary outcomes (2)

  1. Overall Survival

    The first day of treatment to the date that death is reported or last survival status reported or

    Measured: every 8 weeks

  2. Objective Response rate

    The date of first evaluation to the date of disease progression

    Measured: every 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2009 (estimated)
  2. Study startJun 2010
  3. Primary completionDec 2013 (estimated)
  4. Study completionMar 2014 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01027676
Sponsor's protocol ID
NCCCTS-09-433
Status last verified
Nov 2013
First submitted
8 Dec 2009
Last updated
14 Nov 2013
Results posted
No
Data monitoring committee
No

Publications

  • Han JY, Lee SH, Lee GK, Yun T, Lee YJ, Hwang KH, Kim JY, Kim HT. Phase I/II study of gefitinib (Iressa((R))) and vorinostat (IVORI) in previously treated patients with advanced non-small cell lung cancer. Cancer Chemother Pharmacol. 2015 Mar;75(3):475-83. doi: 10.1007/s00280-014-2664-9. Epub 2015 Jan 1.

    PubMed 25552401

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Study treatment in people with Non-Small-Cell Lung Carcinoma, run by National Cancer Center, Korea at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (time frame: every 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01027676, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2013; AzTrials last refreshed its copy on 8 Nov 2026.

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