Solid TumorsPhase 1NCT00550199
LBH589 and Gemcitabine in the Treatment of Solid Tumors
A Phase 1 study testing LBH589, Gemcitabine in people with Solid Tumors, run by SCRI Development Innovations, LLC at 1 site in United States.
Trial summary
This will be a single center phase I dose escalation trial. LBH589 will be administered orally twice weekly. Gemcitabine will be administered intravenously over 30 minutes on days 1, 8, and 15 every 28 days. Dose escalation will begin at Dose Level 1. Three patients will be enrolled at each dose level. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- LBH589, Gemcitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Feb 2010
- Phase
- Phase 1
- 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
- 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:
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Tennessee Oncology, PLLC
Nashville, Tennessee, 37023
About this study
Official title: A Phase I Study of LBH589 in Combination With Gemcitabine in the Treatment of Solid Tumors
This will be a single center phase I dose escalation trial. LBH589 will be administered orally twice weekly. Gemcitabine will be administered intravenously over 30 minutes on days 1, 8, and 15 every 28 days. Dose escalation will begin at Dose Level 1. Three patients will be enrolled at each dose level. If 1/3 patients experiences dose-limiting toxicity, the dose level will be expanded to 6 patients. If 2/6 patients experience dose-limiting toxicity at a specific dose level, then the previous dose level will be considered the recommended phase II dose. Dose escalation will continue until the maximum tolerated dose is determined or until all dose levels outlined in the protocol have been completed. A total of 10 patients will be treated at the dose that is recommended for further phase II evaluation to further assess the safety of the combination regimen. Toxicity assessments will be ongoing and disease assessments will be repeated every 2 treatment cycles. Patients will be allowed to continue on study until disease progression unless toxicity warrants drug discontinuation.
- Conditions
- Solid Tumors
- Being tested
- LBH589, Gemcitabine
- Keywords
- Solid Tumors, Phase I, LBH589, Gemcitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LBH589, GemcitabineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| LBH589 and Gemcitabine | Experimental | Phase I dose escalation study Receives: Drug: LBH589, Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2007 (estimated)
- Study startNov 2007
- Primary completionFeb 2010
- Study completionFeb 2010
Why it stopped: Study terminated due to LBH589 toxicity.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- SCRI Development Innovations, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Howard Burris, M.D., Study chair, SCRI Development Innovations, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00550199
- Sponsor's protocol ID
- SCRI REFMAL 120
- Other IDs
- IND 79,355
- Status last verified
- Aug 2013
- First submitted
- 26 Oct 2007
- Last updated
- 19 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of LBH589 in Combination With Gemcitabine in the Treatment of Solid Tumors
- ClinicalTrials.gov ID
- NCT00550199
- Acronym / sponsor ID
- SCRI REFMAL 120
- Conditions
- Solid Tumors
- Keywords
- Solid Tumors, Phase I, LBH589, Gemcitabine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to LBH589 toxicity.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- SCRI Development Innovations, LLCUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Nov 2007
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 29 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a single center phase I dose escalation trial. LBH589 will be administered orally twice weekly. Gemcitabine will be administered intravenously over 30 minutes on days 1, 8, and 15 every 28 days. Dose escalation will begin at Dose Level 1. Three patients will be enrolled at each dose level. If 1/3 patients experiences dose-limiting toxicity, the dose level will be expanded to 6 patients. If 2/6 patients experience dose-limiting toxicity at a specific dose level, then the previous dose level will be considered the recommended phase II dose. Dose escalation will continue until the maximum tolerated dose is determined or until all dose levels outlined in the protocol have been completed. A total of 10 patients will be treated at the dose that is recommended for further phase II evaluation to further assess the safety of the combination regimen. Toxicity assessments will be ongoing and disease assessments will be repeated every 2 treatment cycles. Patients will be allowed to continue on study until disease progression unless toxicity warrants drug discontinuation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LBH589 and Gemcitabine | Experimental | Drug: LBH589, GemcitabinePhase I dose escalation study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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.
Key exclusion criteria (24 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LBH589, GemcitabinePhase 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. | Drug | LBH589 and Gemcitabine |
Primary outcome
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
Results and safety
The study was stopped early (reason given: Study terminated due to LBH589 toxicity.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Howard Burris, M.D. study chair
SCRI Development Innovations, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LBH589, Gemcitabine in people with Solid Tumors, run by SCRI Development Innovations, LLC at 1 site in United States.
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 18 inclusion and 24 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: stopped early, as of the sponsor's last update on 19 Aug 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 United States. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study terminated due to LBH589 toxicity.). 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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2013.