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A Phase II Study of LBH589 in the Treatment of Patients With Refractory Clear Cell Renal Carcinoma

Phase 2
18 Years
Not Enrolling
Renal Cell Carcinoma

Thank you

Trial Information

A Phase II Study of LBH589 in the Treatment of Patients With Refractory Clear Cell Renal Carcinoma

Inhibition of histone deacetylase (HDAC) provides a potential target for cancer treatment.
Histones are components of the core proteins of nucleosomes, and acetylation and
deacetylation of these proteins play a role in the regulation of gene expression. HDAC
activity is known to be increased in many types of malignant cells; HDAC inhibitors have
been shown to induce differentiation, cell cycle arrest, and apoptosis in cultured tumor
cells. Since this tumor-associated mechanism is common to many types of cancer, HDAC may
have a broad role in cancer treatment.

Inclusion Criteria:

- Histologically documented metastatic or locally unresectable clear cell renal
carcinoma. In patients with mixed histologies, the clear cell component must
comprise > 75% of the cancer.

- Documented disease progression or intolerance while receiving treatment with: a)
sunitinib, sorafenib, or both, and b) temsirolimus.

- Maximum of 4 prior systemic regimens allowed and may include other targeted agents,
immunotherapy and chemotherapy.

- Measurable disease by RECIST criteria.

- ECOG PS 0 or 1.

- Laboratory values as follows: ANC >= 1500/μL, Hgb >= 9 g/dL, Platelets >= 100,000/uL,
AST/SGOT and ALT/SGPT <= 2.5 x ULN or <= 5.0 x ULN in patients with liver metastases,
Creatinine <= 2.0 mg/dL Or Calculated Creatinine Clearance >= 50 ml/min, Albumin >= 3
g/dL, Potassium >= lower limit normal (LLN),Phosphorous >= LLN, Calcium >= LLN,
Magnesium > LLN

- Women of childbearing potential must have a negative serum or urine pregnancy test
performed within 7 days prior to start of treatment.

- Life expectancy > 12 weeks.

- Accessible for treatment and follow-up.

- All patients must be able to understand the nature of the study and give written
informed consent prior to study entry.

Exclusion Criteria:

- Age < 18 years of age.

- Prior treatment with an HDAC inhibitor.

- Impaired cardiac function

- Ongoing therapy with antiarrhythmics or other medications associated with QTc

- Uncorrected hypokalemia or hypomagnesemia.

- Uncontrolled hypertension or cardiac arrhythmias.

- Active parenchymal brain metastases. Patients who have had brain metastases
resected, or have received radiation therapy ending > 8 weeks prior to study entry
are eligible if they meet all of the following criteria: 1) residual neurologic
symptoms < grade 1, 2) no dexamethasone requirement, 3) follow-up MRI shows
regression of lesions after treatment, with no new lesions appearing.

- Active meningeal metastases.

- Known diagnosis of human immunodeficiency virus (HIV) infection.

- Unresolved diarrhea > CTCAE grade 1.

- Concomitant requirement for medication classified as CYP3A4 inducers or inhibitors.

- Chemotherapy, investigational drug therapy, major surgery < 4 weeks prior to starting
study drug or patients that have not recovered from side effects of previous therapy.

- Patient is < 5 years free of another primary malignancy except if the other primary
malignancy is not currently clinically significant or requiring active intervention,
or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in
situ. Existence of any other malignant disease is not allowed.

- Concomitant use of any anti-cancer therapy or radiation therapy.

- Pregnant or breast feeding or female of reproductive potential not using 2 effective
methods of birth control.

- Male patients whose sexual partners are women of childbearing potential not using
effective birth control.

- Patients with gastrointestinal (GI) tract disease, causing the inability to take oral
medication, malabsorption syndrome, a requirement for intravenous (IV) alimentation,
prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease.

- Other concurrent severe, uncontrolled infection or intercurrent illness

- Abnormal thyroid function (TSH or free T4) detected at screening. Patients with
known hypothyroidism who are stable on thyroid replacement are eligible.

Type of Study:


Study Design:

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

Outcome Measure:

To Evaluate the Efficacy of LBH589 in the Treatment of Patients With Refractory Clear Cell Carcinoma, as Measured by Progression-free Survival

Outcome Time Frame:

18 months

Safety Issue:


Principal Investigator

John D. Hainsworth, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Sarah Cannon Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

January 2008

Completion Date:

June 2010

Related Keywords:

  • Renal Cell Carcinoma
  • Renal Cell Carcinoma
  • Refractory
  • LBH589
  • Carcinoma
  • Carcinoma, Renal Cell
  • Kidney Neoplasms



Florida Cancer SpecialistsFort Myers, Florida  33901
Northeast Georgia Medical CenterGainesville, Georgia  30501
Baton Rouge General Medical CenterBaton Rouge, Louisiana  70821-2511
Methodist Cancer CenterOmaha, Nebraska  68114
Peninsula Cancer InstituteNewport News, Virginia  23601
Center for Cancer and Blood DisordersBethesda, Maryland  20817
Tennessee Oncology, PLLCClarksville, Tennessee  37043
Oncology Hematology CareCincinnati, Ohio  45242
Hematology Oncology Associates of Northern NJMorristown, New Jersey  07960
Chattanooga Oncology Hematology AssociatesChattanooga, Tennessee  37404