Clinical trial · Interventional
LBH589 Treatment for Refractory Clear Cell Renal Carcinoma
A Phase II Study of LBH589 in the Treatment of Patients With Refractory Clear Cell Renal Carcinoma
NCT00550277CI-TRIAL-00055186completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Inhibition of histone deacetylase (HDAC) provides a novel approach for cancer treatment. LBH589, an oral HDAC inhibitor, has been well tolerated in phase I trials and has shown activity against several types of cancer. In this nonrandomized phase II trial, we are investigating the activity of LBH589 in the treatment of patients with refractory clear cell renal carcinoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LBH589 | Drug | Panobinostat | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Treatment
- description
- LBH589 will be administered orally at a dose of 45 mg (1 - 5 mg capsule and 2 - 20 mg capsules) on Monday and Thursday of each week (twice weekly). To enable patients to undergo cardiac monitoring, all patients must begin treatment on a Monday, and continue Monday/Thursday dosing during subsequent treatment cycles. Patients with objective response or stable disease after re-evaluation at week 8 will continue LBH589 at the same dose until disease progression, unacceptable toxicity and/or at the discretion of the investigator.
- interventionNames
- Drug: LBH589
Primary outcomes (1)
- measure
- Progression-free Survival
- timeFrame
- 18 months
- description
- Progression-free survival was defined as the interval from the date of first treatment with panobinostat until the date that disease progression or death occurred. Progressive disease (PD): 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 prolongation. * 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.
References
Publications (1)
- BACKGROUNDHainsworth JD, Infante JR, Spigel DR, Arrowsmith ER, Boccia RV, Burris HA. A phase II trial of panobinostat, a histone deacetylase inhibitor, in the treatment of patients with refractory metastatic renal cell carcinoma. Cancer Invest. 2011 Aug;29(7):451-5. doi: 10.3109/07357907.2011.590568. Epub 2011 Jun 22. PMID 21696296