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Colorectal CancerPhase 2NCT00690677

Phase II Trial of LBH589 in Refractory Colorectal Cancer

A Phase 2 study testing LBH589 in people with Colorectal Cancer, run by Swedish Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine the effects of the study drug, LBH589, on patients with metastatic colorectal cancer that has continued to grow despite previous treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
LBH589
Type of treatment
Pill or oral medicine
How many people
29 participants
Where
1 siteUnited States
Study dates
Jun 2008to Dec 2011
Phase
Phase 2
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

  • Male or female patients aged ≥ 18 years old
  • Patients with measurable metastatic colorectal cancer
  • Refractory to at least 2 standard chemotherapy/biologic regimens to include 5FU, oxaliplatin, irinotecan, bevacizumab, cetuximab or combinations thereof
  • ECOG Performance Status of ≤ 2
  • Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
  • Laboratory values as follows:
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  • Neutrophil count of >1500/mm3
  • Platelet count of > 100,000/mm3L
  • Hemoglobin ≥ 9 g/dL
  • AST/SGOT and ALT/SGPT ≤ 2.5 x upper limit of normal (ULN) or ≤ 5.0 x ULN if the transaminase elevation is due to disease involvement
  • Serum bilirubin ≤ 1.5 x ULN
  • Serum creatinine ≤ 1.5 x ULN or 24-hour creatinine clearance ≥ 50 ml/min
  • Total serum calcium (corrected for serum albumin) or ionized calcium ≥ LLN
  • Serum potassium ≥ LLN
  • Serum sodium ≥ LLN
  • Serum albumin ≥ LLN or 3g/dl
  • Patients with any elevated Alkaline Phosphatase due to bone metastasis can be enrolled
  • Baseline MUGA or ECHO must demonstrate LVEF ≥ the lower limit of the institutional normal
  • TSH and free T4 within normal limits (patients may be on thyroid hormone replacement)
  • Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days of the first administration of study treatment. and must be willing to use two methods of contraception one of them being a barrier method during the study and for 3 months after last study drug administration
  • Radiographically bi-dimensionally measurable disease that has not been previously irradiated. If the patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation
  • Life expectancy must be greater than 12 weeks

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 one of the following:
  • Screening ECG with a QTc > 450 msec confirmed by central laboratory prior to enrollment to the study
  • Patients with congenital long QT syndrome
  • History of sustained ventricular tachycardia
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  • Any history of ventricular fibrillation or torsades de pointes
  • Bradycardia defined as heart rate < 50 beats per minute. Patients with a pacemaker and heart rate ≥ 50 beats per minute are eligible.
  • Patients with a 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)
  • Uncontrolled hypertension
  • Concomitant use of drugs with a risk of causing torsades de pointes
  • Concomitant use of CYP3A4 inhibitors
  • Patients with unresolved diarrhea > 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, any investigational drug 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 or radiation therapy
  • 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 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 a history of another primary malignancy within 5 years other than curatively treated CIS of the cervix, or basal or squamous cell carcinoma of the skin
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Swedish Medical Center

    Seattle, Washington, 98104

Other trials in United States

About this study

The purpose of this study is to determine the effects of the study drug, LBH589, on patients with metastatic colorectal cancer that has continued to grow despite previous treatment.

Being tested
LBH589
Keywords
LBH589, Metastatic Colorectal Cancer, Refractory Colorectal Cancer
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LBH589Drug

    LBH589 will be administered orally at a dose of 30mg (1 - 20mg capsule and 2 - 5g capsules) on Monday, Wednesday and Friday of each week (three times a week). Patients may continue treatment with oral LBH589 until they experience unacceptable toxicity that precludes further treatment, disease progression, and/or at the discretion of the investigator.

    The LBH589 capsules should be swallowed by mouth with a glass of water in the morning. The recommended way to take LBH589 is after not eating for at least 2 hours. You should also not eat for another 2 hours after taking your LBH589 capsules. The daily dose of LBH589 should be taken at approximately the same time each day. You should avoid eating grapefruit, seville oranges, or drinking grapefruit or seville orange juice during the study.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To evaluate the effect of LBH589 on overall survival (OS) in patients with colorectal cancer

    Measured: 18 months

Secondary outcomes (1)

  1. Time to tumor progression and response rates

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2008 (estimated)
  2. Study startJun 2008
  3. Primary completionDec 2011
  4. Study completionDec 2011

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00690677
Sponsor's protocol ID
CLBH589BUS19T
Other IDs
CRC GOLP CNOV 0823
Status last verified
Jan 2012
First submitted
3 Jun 2008
Last updated
18 Jan 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LBH589 in people with Colorectal Cancer, run by Swedish Medical Center 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 22 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: finished, as of the sponsor's last update on 18 Jan 2012. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 evaluate the effect of LBH589 on overall survival (OS) in patients with colorectal cancer (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00690677.

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 18 Jan 2012.

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