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Phase I Study of LBH589 in Combination With Erlotinib for Advanced Aerodigestive Tract Cancers (CLBH5889CUS11T)

Phase 1
18 Years
Open (Enrolling)
Lung Cancer, Head and Neck Cancer

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Trial Information

Phase I Study of LBH589 in Combination With Erlotinib for Advanced Aerodigestive Tract Cancers (CLBH5889CUS11T)

Patients will be asked to remain on the study for a minimum of 3 months unless the study
doctor decides the patient should be taken off the study or the patient withdraws from the
study. Each cycle of treatment is 21 days in length and there is a 30 day follow-up after
the patient receives their last dose of study drug. Scans will be repeated to see how their
cancer is doing after two cycles of treatment. These scans wil be repeated every 2 cycles
for the first 6 cycles and then every 3 cycles for as long as the patient remains on the
study. The patient may continue on therapy as long as they are responding or have stable

Inclusion Criteria:

- Histologically or cytologically documented diagnosis of advanced/metastatic NSCLC or
Head and Neck cancer.

- Male or female patients aged ≥ 18 years old

- Ability to provide written informed consent obtained prior to participation in the
study and any related procedures being performed

- Have progressive and measurable disease that can be measured by Response Evaluation
Criteria in Solid Tumors (RECIST) criteria

- Patients must have discontinued prior systemic chemotherapy by 14 days.

- Patients must meet the following laboratory criteria:

1. Serum albumin ≥ 3g/dL

2. Aspartic transaminase (AST/SGOT) and alanine transaminase (ALT/SGPT) ≤ 2.5 x
upper limit of normal (ULN)or ≤ 5.0 x ULN if the transaminase elevation is due
to leukemic involvement

3. Serum bilirubin ≤ 1.5 x ULN

4. Serum creatinine ≤ 1.5 x ULN or 24-hour creatinine clearance ≥ 50 ml/min

5. Serum potassium ≥ lower limit of normal (LLN) and ≤ ULN

6. Serum phosphorous ≥ LLN

7. Serum total calcium (corrected for serum albumin) or serum ionized calcium ≥ LLN

8. Serum magnesium ≥ LLN

9. Absolute neutrophil count (ANC)(ANC: segmented and bands) ≥ 1.5 X10^9/L

10. Platelets ≥ 100 X 10^9/L

- Baseline multiple gated acquisition imaging (MUGA) or echocardiogram (ECHO) must
demonstrate left ventricular ejection fraction (LVEF) ≥ the lower limit of the
institutional normal

- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1

- Reproductive potential must be either terminated (by surgery, radiation, or
menopause) or attenuated by the use of an approved contraceptive method during and
for 3 to 6 months following the study.

- Patient instructed that intravenous (IV) bisphosphonates will be withheld for the
first 8 weeks of LBH589 therapy due to risk of hypocalcemia.

Exclusion Criteria:

- Impaired cardiac function including any one of the following:

1. Screening electrocardiogram (ECG) with a corrected QT (QTc) > 450 msec confirmed
by central laboratory prior to enrollment to the study

2. Patients with congenital long QT syndrome

3. History of sustained ventricular tachycardia

4. Any history of ventricular fibrillation or torsades de pointes

5. Bradycardia defined as heart rate < 50 beats per minute. Patients with a
pacemaker and heart rate ≥ 50 beats per minute are eligible.

6. Patients with a myocardial infarction or unstable angina within 6 months of
study entry

7. Congestive heart failure - New York Heart Association (NYHA) class III or IV

8. Right bundle branch block and left anterior hemiblock (bifascicular block)

9. Patients with a history of uncontrolled or chronic atrial fibrillation.

- Uncontrolled hypertension, blood pressure (BP) >180/110 on 3 separate occasions
despite oral antihypertensive medications

- Concomitant use of drugs with a risk of causing torsades de pointes Concomitant use
of CYP3A4 inhibitors

- Patients with documented central nervous system or leptomeningeal metastasis (brain
metastasis) at the time of study entry. Patients with prior brain metastasis may be
considered if they have completed their treatment for brain metastasis, no longer
require corticosteroids, and are asymptomatic.

- Patients with unresolved diarrhea > Common Terminology Criteria for Adverse Events
(CTCAE) grade 1

- Impairment of gastrointestinal (GI) function or GI disease that may significantly
alter the absorption of oral LBH589

- Other concurrent severe and/or uncontrolled medical conditions

- Patients who have received chemotherapy < 14 days, any investigational drug < 14 days
or undergone major surgery < 4 weeks prior to starting study drug or who have not
recovered from side effects of such therapy.

- Concomitant use of any anti-cancer therapy (except erlotinib) or radiation therapy.

- Female patients who are pregnant or breast feeding or patients of reproductive
potential not using two effective methods of birth control. Women of childbearing
potential (WOCBP) must have a negative serum pregnancy test within 7 days of the
first administration of oral LBH589

- Male patients whose sexual partners are WOCBP not using effective birth control

- Patients with known positivity for human immunodeficiency virus (HIV) or hepatitis C;
baseline testing for HIV and hepatitis C is not required

- Patients with any significant history of non-compliance to medical regimens or with
inability to grant a reliable informed consent

- Patients who are not willing to refrain from wearing contact lenses during study
participation will be excluded.

Type of Study:


Study Design:

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

Outcome Measure:

Maximum Tolerated Dose (MTD)

Outcome Description:

Determine safety and tolerability of erlotinib and LBH589B and establish a recommended phase II expansion dosing of LBH589B and erlotinib in patients with advanced aerodigestive tract cancers.

Outcome Time Frame:

4 Months

Safety Issue:


Principal Investigator

Jhanelle Gray, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

November 2008

Completion Date:

December 2013

Related Keywords:

  • Lung Cancer
  • Head and Neck Cancer
  • Metastatic
  • erlotinib
  • aerodigestive tract cancers
  • non-small cell lung cancer
  • H&N cancer
  • Head and Neck Neoplasms
  • Lung Neoplasms



H. Lee Moffitt Cancer Center & Research Institute Tampa, Florida  33612