- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00550199
LBH589 and Gemcitabine in the Treatment of Solid Tumors
A Phase I Study of LBH589 in Combination With Gemcitabine in the Treatment of Solid Tumors
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Tennessee
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Nashville, Tennessee, United States, 37023
- Tennessee Oncology, PLLC
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Histologically documented metastatic or locally advanced, incurable malignancy for which gemcitabine is clinically appropriate (e.g., non-small cell lung cancer, breast, ovarian, bladder cancer and lymphoma).
- Male or female patients aged ≥ 18 years old.
- Maximum of 3 prior regimens in a metastatic setting 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
- Bilirubin < 1.5 mg/dL
- 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 24-hour Creatinine Clearance > 50 ml/min
- Albumin > 3 g/dL
- Potassium > lower limit normal (LLN)
- Phosphorous > LLN
- Calcium > LLN
- Magnesium > LLN
8. Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to start of treatment. 9. Life expectancy > 12 weeks. 10. Accessible for treatment and follow-up. 11. All patients must be able to understand the nature of the study and be given written informed consent prior to study entry.
Exclusion Criteria:
- Prior HDAC, DAC, HSP90 inhibitors or valproic acid for the treatment of cancer. Patients who will need valproic acid for any medical condition during the study or within 5 days prior to first LBH589 treatment
Impaired cardiac function including any of the following:
- Screening ECG with a QTc > 450 msec.
- Congenital long QT syndrome.
- History of sustained ventricular tachycardia.
- Any history of ventricular fibrillation or torsades de pointes.
- Bradycardia defined as heart rate < 50 beats per minutes. Patients wit a pacemaker and heart rate > 50 beats per minute are eligible.
- Myocardial infarction or unstable angina within 6 months of study entry.
- Congestive heart failure (NY Heart Association class III or IV.
- Right bundle branch block and left anterior hemiblock (bifasicular block).
- Atrial fibrillation or flutter.
- Uncontrolled hypertension (systolic blood pressure [BP] 180 or diastolic BP >100mm Hg) or uncontrolled cardiac arrhythmias.
- Active CNS disease, including meningeal metastases.
- Known diagnosis of human immunodeficiency virus (HIV) infection.
- Unresolved diarrhea > CTCAE grade 1.
- 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 other than protocol required gemcitabine.
- Women who are pregnant or breast feeding or women of childbearing potential (WOCBP) not willing to use a double barrier method of contraception during the study and 3 months after the end of treatment. One of these methods of contraception must be a barrier method. WOCBP are defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months (i.e., who has had menses any time in the preceding 12 consecutive months). Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 7 days of the first administration of oral LBH589.
- Male patients whose sexual partners are WOCBP not using a double method of contraception during the study and 3 months after the end of treatment. One of these methods must be a condom.
- 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 (e.g., Crohn's disease, ulcerative colitis).
- Other concurrent severe, uncontrolled infection or intercurrent illness, including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients with uncontrolled coagulopathy.
- Abnormal thyroid function (TSH or free T4) detected at screening. Patients with known hypothyroidism who are stable on thyroid replacement are eligible.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: LBH589 and Gemcitabine
Phase I dose escalation study
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Phase I dose escalation: LBH589 will be administered orally twice weekly.
Gemcitabine will be administered intravenously over 30 minutes on days 1, 8, and 15 every 28 days.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine the maximum tolerated doses and dose limiting toxicities of LBH589 in combination with gemcitabine when administered to patients with advanced incurable malignant solid tumors.
Time Frame: 18 months
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18 months
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Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Howard Burris, M.D., SCRI Development Innovations, LLC
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Histone Deacetylase Inhibitors
- Gemcitabine
- Panobinostat
Other Study ID Numbers
- SCRI REFMAL 120
- IND 79,355
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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